Publications by authors named "Sébastien Pili Floury"

53 Publications

Impact on antimicrobial consumption of procalcitonin-guided antibiotic therapy for pneumonia/pneumonitis associated with aspiration in comatose mechanically ventilated patients: a multicenter, randomized controlled study.

Ann Intensive Care 2021 Oct 12;11(1):145. Epub 2021 Oct 12.

Medical Intensive Care Unit, University Hospital, Besançon, France.

Background: In comatose patients receiving oro-tracheal intubation for mechanical ventilation (MV), the risk of aspiration is increased. Aspiration can lead to chemical pneumonitis (inflammatory reaction to the gastric contents), or aspiration pneumonia (infection caused by inhalation of microorganisms). Distinguishing between the two types is challenging. We tested the interest of using a decisional algorithm based on procalcitonin (PCT) values to guide initiation and discontinuation of antibiotic therapies in intubated patients.

Methods: The PROPASPI (PROcalcitonin Pneumonia/pneumonitis Associated with ASPIration) trial is a multicenter, prospective, randomized, controlled, single-blind, superiority study comparing two strategies: (1) an intervention group where threshold PCT values were used to guide initiation and discontinuation of antibiotics (PCT group); and (2) a control group, where antibiotic therapy was managed at the physician's discretion. Patients aged 18 years or over, intubated for coma (Glasgow score ≤ 8), with MV initiated within 48 h after admission, were eligible. The primary endpoint was the duration of antibiotic treatment during the first 15 days after admission to the ICU.

Results: From 24/2/2015 to 28/8/2019, 1712 patients were intubated for coma in the 5 participating centers, of whom 166 were included in the study. Data from 159 were available for intention-to-treat analysis: 81 in the PCT group, and 78 in the control group. Overall, 67 patients (43%) received antibiotics in the intensive care unit (ICU); there was no significant difference between groups (37 (46%) vs 30 (40%) for PCT vs control, p = 0.432). The mean duration of antibiotic treatment during the first 15 days in the ICU was 2.7 ± 3.8 days; there was no significant difference between groups (3.0 ± 4.1 days vs 2.3 ± 3.4 days for PCT vs control, p = 0.311). The mean number of days under MV was significantly higher in the PCT group (3.7 ± 3.6 days) than in controls (2.7 ± 2.5 days, p = 0.033). The duration of ICU stay was also significantly longer in the PCT group: 6.4 ± 6.5 days vs 4.6 ± 3.5 days in the control group (p = 0.043). After adjustment for SAPS II score, the difference in length of stay and duration of mechanical ventilation between groups was no longer significant.

Conclusion: The use of PCT values to guide therapy, in comparison to the use of clinical, biological (apart from PCT) and radiological criteria, does not modify exposure to antibiotics in patients intubated for coma. Trial registration Clinicaltrials.gov Identifier NCT02862314.
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http://dx.doi.org/10.1186/s13613-021-00931-4DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8505789PMC
October 2021

Minimum effective concentration of ropivacaine for 90% ultrasound-guided axillary brachial plexus block, with or without intravenous dexamethasone.

J Clin Anesth 2021 Jul 28;75:110468. Epub 2021 Jul 28.

Department of Anesthesiology and Intensive Care Medicine, University Hospital of Besancon, Besancon, France. Electronic address:

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http://dx.doi.org/10.1016/j.jclinane.2021.110468DOI Listing
July 2021

Evaluating the Risk of Irreversible Intestinal Necrosis Among Critically Ill Patients With Nonocclusive Mesenteric Ischemia.

Am J Gastroenterol 2021 07;116(7):1506-1513

Medical Intensive Care Unit, University of Bourgogne Franche-Comté, CHRU Besançon, Besançon, France.

Introduction: To identify factors associated with irreversible transmural necrosis (ITN) among critically ill patients experiencing nonocclusive mesenteric ischemia (NOMI) and to compare the predictive value regarding ITN risk stratification with that of the previously described Clichy score.

Methods: All consecutive patients admitted to the intensive care unit between 2009 and 2019 who underwent exploratory laparotomy for NOMI and who had an available contrast-enhanced computed tomography with at least 1 portal venous phase were evaluated for inclusion. Clinical, laboratory, and radiological variables were collected. ITN was assessed on pathological reports of surgical specimens and/or on laparotomy findings in cases of open-close surgery. Factors associated with ITN were identified by univariate and multivariate analysis to derive a NOMI-ITN score. This score was further compared with the Clichy score.

Results: We identified 4 factors associated with ITN in the context of NOMI: absence of bowel enhancement, bowel thinning, plasma bicarbonate concentration ≤15 mmol/L, and prothrombin rate <40%. These factors were included in a new NOMI-ITN score, with 1 point attributed for each variable. ITN was observed in 6%, 38%, 65%, 88%, and 100% of patients with NOMI-ITN score ranging from 0 to 4, respectively. The NOMI-ITN score outperformed the Clichy score for the prediction of ITN (area under the receiver operating characteristics curve 0.882 [95% confidence interval 0.826-0.938] vs 0.674 [95% confidence interval 0.582-0.766], respectively, P < 0.001).

Discussion: We propose a new 4-point score aimed at stratifying risk of ITN in patients with NOMI. The Clichy score should be applied to patients with occlusive acute mesenteric ischemia only.
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http://dx.doi.org/10.14309/ajg.0000000000001274DOI Listing
July 2021

Lung Recruiting Effect of Prone Positioning in Spontaneously Breathing Patients with COVID-19 Assessed by Electrical Impedance Tomography.

Am J Respir Crit Care Med 2021 08;204(4):476-477

Department of Anesthesiology and Intensive Care Medicine, Centre Hospitalier Régional Universitaire de Besançon, Besançon, France; and.

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http://dx.doi.org/10.1164/rccm.202008-3044IMDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8480241PMC
August 2021

Extracorporeal Membrane Oxygenation Cannula-Related Infections: Epidemiology and Risk Factors.

ASAIO J 2021 Jun 1. Epub 2021 Jun 1.

From the Medical Intensive Care Unit, University Hospital, Besancon, France Research Unit EA 3920, University of Franche Comte, Besancon, France Anaesthesia and Surgical Intensive Care Unit, University Hospital, Besancon, France Bacteriology Department, University Hospital, Besancon, France Cardiac Surgery Unit, University Hospital, Besancon, France Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Faculty of Medicine, Nursing and Health Sciences, Clayton, Australia.

Although being a potential major source of infection in extracorporeal membrane oxygenation (ECMO) patients, data regarding cannula-related infections (CRI) remain scarce. We therefore aimed at describing the epidemiology of CRI among critically ill patients supported by ECMO. Between October 2017 and November 2019, adult patients supported by either venoarterial (VA), venopulmonary arterial, or venovenous (VV) ECMO for more than 24 hours were prospectively enrolled. When CRI was suspected, cannula swab and subcutaneous needle aspirate samples were obtained for microbiological culture. Cannula tips were systematically sent for culture at the time of ECMO removal. Primary end-point was CRI, which was defined by sepsis or local sign of cannula infection and at least one positive culture among swab, subcutaneous needle aspirate or tip. Multivariate analysis was performed to identify risk factors of CRI. Hundred patients were included, including 77 VA, 12 venopulmonary arterial, and 11 VV ECMO. Cannula-related infections were diagnosed after a median duration of ECMO of 10 [7-13] days. Rate of CRI was 24%, including 10% with bacteremia. Most frequent involved pathogens were Enterobacteriaceae (n = 14), Enterococci (n = 8), and coagulase-negative Staphylococci (n = 7). By multivariate analysis, diabetes and ECMO duration were independently associated with CRI.
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http://dx.doi.org/10.1097/MAT.0000000000001505DOI Listing
June 2021

Individual versus collective debriefing after interprofessional training course simulation: The randomised DEBRIEF-SIM trial.

Anaesth Crit Care Pain Med 2021 04 17;40(2):100828. Epub 2021 Mar 17.

Department of Anaesthesiology and Intensive Care Medicine, University Hospital of Besancon, F-25000 Besancon, France; SFR FED 4234, EA 3920, University of Franche-Comté, F-25000 Besancon, France.

Introduction: Debriefing is a critical phase in simulation-based education that is extremely time-consuming for the instructors. The aim of the study was to assess whether a collective debriefing was non-inferior to an individual debriefing to improve learning outcomes after a simulation session.

Methods: This randomised controlled multicentre non-inferiority study included pairs comprising one resident and one student nurse in anaesthesia. Each pair underwent two sessions of a simulated life-threatening emergency held at a 6-week interval. Six participant pairs underwent simulation sessions every half-day of training. The debriefing performed after the first session was either individual (1 debriefing by pair; individual group) or collective (1 debriefing by 6 pairs; collective group). The primary outcome was the evolution of a 34-parameter technical skill score (Delta-TSS-34) between the two simulation sessions. The non-inferiority margin was 5. The change in the Anaesthetists' Non-Technical Skills score (Delta-ANTS), and the debriefing duration per participant pair were secondary endpoint measures.

Results: Respectively 23 and 21 pairs were included in the collective and individual groups. Delta-TSS-34 was non-inferior in the collective group compared to the individual group (mean intergroup difference [95% confidence interval]: 2.71 [0.44-4.98]). Delta-ANTS did not significantly differ between the two groups (median [interquartile range]: 22 [10-37] versus 25 [17-35], p = 0.57; respectively in the collective and individual groups). The debriefing duration per participant pair was significantly lower in the collective group (10 [10-11] min versus 27 [25-28] min; p < 0.001).

Conclusion: Collective debriefing was non-inferior to individual debriefing to improve learning outcomes after simulation of medical emergencies and allows a significant reduction in the time dedicated to the debriefing.
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http://dx.doi.org/10.1016/j.accpm.2021.100828DOI Listing
April 2021

Continuous Pneumatic Regulation of Tracheal Cuff Pressure to Decrease Ventilator-associated Pneumonia in Trauma Patients Who Were Mechanically Ventilated: The AGATE Multicenter Randomized Controlled Study.

Chest 2021 Aug 13;160(2):499-508. Epub 2021 Mar 13.

Service des Urgences et SAMU 86 Centre 15, CHU de Poitiers, France; Université de Poitiers, Faculté de Médecine, Poitiers, France; INSERM U1070, Pharmacologie des Agents anti-infectieux, France. Electronic address:

Background: Ventilator-associated pneumonia (VAP) is the most frequent health care-associated infection in severely ill patients, and aspiration of contaminated oropharyngeal content around the cuff of the tracheal tube is the main route of contamination.

Research Question: Is continuous regulation of tracheal cuff pressure using a pneumatic device superior to manual assessment three times daily using a portable manometer (routine care) in preventing VAP in patients with severe trauma?

Study Design And Methods: In this open-label, randomized controlled superiority trial conducted in 13 French ICUs, adults (age ≥ 18 years) with severe trauma (Injury Severity Score > 15) and requiring invasive mechanical ventilation for ≥ 48 h were enrolled. Patients were randomly assigned (1:1) via a secure Web-based random number generator in permuted blocks of variable sizes to one of two groups according to the method of tracheal cuff pressure control. The primary outcome was the proportion of patients developing VAP within 28 days following the tracheal intubation, as determined by two assessors masked to group assignment, in the modified intention-to-treat population. This study is closed to new participants.

Results: A total of 434 patients were recruited between July 31, 2015, and February 15, 2018, of whom 216 were assigned to the intervention group and 218 to the control group. Seventy-three patients (33.8%) developed at least one episode of VAP within 28 days following the tracheal intubation in the intervention group compared with 64 patients (29.4%) in the control group (adjusted subdistribution hazard ratio, 0.96; 95% CI, 0.76-1.20; P = .71). No serious adverse events related to the use of the pneumatic device were noted.

Interpretation: Continuous regulation of cuff pressure of the tracheal tube using a pneumatic device was not superior to routine care in preventing VAP in patients with severe trauma.

Clinical Trial Registration: ClinicalTrials.gov; No.: NCT02534974; URL: www.clinicaltrials.gov.
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http://dx.doi.org/10.1016/j.chest.2021.03.007DOI Listing
August 2021

Diagnostic performance of CT for the detection of transmural bowel necrosis in non-occlusive mesenteric ischemia.

Eur Radiol 2021 Sep 14;31(9):6835-6845. Epub 2021 Feb 14.

Department of Radiology, University of Bourgogne Franche-Comté, CHRU Besançon, 25030, Besançon, France.

Objectives: To evaluate the diagnostic performance of CT for transmural necrosis (TN) in non-occlusive mesenteric ischemia (NOMI) according to the bowel segment involved.

Methods: From January 2009 to December 2019, all patients admitted to the intensive care unit (ICU) and requiring laparotomy for NOMI were retrospectively studied. CT had to have been performed within 24 h prior to laparotomy and were reviewed by two abdominal radiologists, with a consensus reading in case of disagreement. A set of CT features of mesenteric ischemia were assessed, separating the stomach, jejunum, ileum, and right (RC) and left colon (LC). Univariate and multivariate analyses were performed to identify features associated with TN. Its influence on overall survival (OS) was assessed.

Results: Among 145 patients, 95 (66%) had ≥ 1 bowel segment with TN, including 7 (5%), 31 (21%), 43 (29%), 45 (31%), and 52 (35%) in the stomach, jejunum, ileum, RC, and LC, respectively. Overall inter-reader agreement of CT features was significantly lower in the colon than in the small bowel (0.59 [0.52-0.65] vs 0.74 [0.70-0.77] respectively). The absence of bowel wall enhancement was the only CT feature associated with TN by multivariate analysis, whatever the bowel segment involved. Proximal TN was associated with poorer OS (p < 0.001).

Conclusions: The absence of bowel wall enhancement remains the most consistent CT feature of transmural necrosis, whatever the bowel segment involved in NOMI. Inter-reader agreement of CT features is lower in the colon than in the small bowel. Proximal TN seems to be associated with poorer OS.

Key Points: • The absence of bowel wall enhancement is the most consistent CT feature associated with transmural necrosis in NOMI, whatever is the bowel segment involved. • Inter-reader agreement is lower in the colon than in the small bowel in NOMI. • In NOMI, the more proximal the bowel necrosis, the worse the prognosis.
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http://dx.doi.org/10.1007/s00330-021-07728-wDOI Listing
September 2021

Semi-elemental versus polymeric formula for enteral nutrition in brain-injured critically ill patients: a randomized trial.

Crit Care 2021 01 20;25(1):31. Epub 2021 Jan 20.

Department of Anesthesiology and Intensive Care Medicine, University Hospital of Besancon, 3 bvd Alexander Fleming, 25000, Besancon, France.

Background: The properties of semi-elemental enteral nutrition might theoretically improve gastrointestinal tolerance in brain-injured patients, known to suffer gastroparesis. The purpose of this study was to compare the efficacy and tolerance of a semi-elemental versus a polymeric formula for enteral nutrition (EN) in brain-injured critically ill patients.

Methods: Prospective, randomized study including brain-injured adult patients [Glasgow Coma Scale (GCS) ≤ 8] with an expected duration of mechanical ventilation > 48 h.

Intervention: an enteral semi-elemental (SE group) or polymeric (P group) formula. EN was started within 36 h after admission to the intensive care unit and was delivered according to a standardized nurse-driven protocol. The primary endpoint was the percentage of patients who received both 60% of the daily energy goal at 3 days and 100% of the daily energy goal at 5 days after inclusion. Tolerance of EN was assessed by the rate of gastroparesis, vomiting and diarrhea.

Results: Respectively, 100 and 95 patients were analyzed in the SE and P groups: Age (57[44-65] versus 55[40-65] years) and GCS (6[3-7] versus 5[3-7]) did not differ between groups. The percentage of patients achieving the primary endpoint was similar (46% and 48%, respectively; relative risk (RR) [95% confidence interval (CI)] = 1.05 (0.78-1.42); p = 0.73). The mean daily energy intake was, respectively, 20.2 ± 6.3 versus 21.0 ± 6.5 kcal/kg/day (p = 0.42). Protein intakes were 1.3 ± 0.4 versus 1.1 ± 0.3 g/kg/day (p < 0.0001). Respectively, 18% versus 12% patients presented gastroparesis (p = 0.21), and 16% versus 8% patients suffered from diarrhea (p = 0.11). No patient presented vomiting in either group.

Conclusion: Semi-elemental compared to polymeric formula did not improve daily energy intake or gastrointestinal tolerance of enteral nutrition.

Trial Registration: EudraCT/ID-RCB 2012-A00078-35 (registered January 17, 2012).
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http://dx.doi.org/10.1186/s13054-020-03456-7DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7818740PMC
January 2021

Atherosclerosis is associated with poorer outcome in non-occlusive mesenteric ischemia.

Eur J Radiol 2021 Jan 30;134:109453. Epub 2020 Nov 30.

Department of Radiology, University of Bourgogne Franche-Comté, CHRU Besançon, 25030, Besançon, France.

Purpose: To evaluate whether abdominal atherosclerosis was associated with poorer outcome in a single-centre cohort of patients suffering from nonocclusive mesenteric ischemia (NOMI).

Methods: From January 2009 to December 2019, 121 consecutive patients from the critical care unit who underwent laparotomy for suspected NOMI and with available unenhanced and contrast-enhanced CT were included. Clinical and biological data at the time of the CT scan were retrospectively extracted from medical charts and reviewed by a single radiologist. Unenhanced CT acquisitions were used to calculate calcium scores of the abdominal aorta, celiac trunk, superior mesenteric artery (SMA) and common iliac arteries according to the Agatston method. Univariate and multivariate analysis were performed.

Results: Among the 121 patients with NOMI and calcium score calculation, only 4 patients had no aortic calcifications (3 %) and 32 had no superior mesenteric artery calcification (26 %). 35 patients (29 %) died within 24 h after the abdominal CT scan. Univariate analysis showed that a total abdominal calcium score greater than 15 000 (last quartile) was significantly associated with death within 24 h (14 (40 %) vs 17 (20 %) patients, p = 0.035). By multivariate analysis, a total abdominal calcium score greater than 15 000 was an independent risk factor for death (HR = 1.94, 95 %CI [1.02-3.73], p = 0.044). Regarding separate calcium scores, only a SMA calcium score greater than 50 was a risk factor for death (HR 2.46, 95 %CI [1.14-3.93], p = 0.019).

Conclusion: Our results show that abdominal atherosclerosis, especially in the SMA, is associated with poorer outcome in NOMI.
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http://dx.doi.org/10.1016/j.ejrad.2020.109453DOI Listing
January 2021

Postoperative Neurocognitive Disorders After Closed-Loop Versus Manual Target Controlled-Infusion of Propofol and Remifentanil in Patients Undergoing Elective Major Noncardiac Surgery: The Randomized Controlled Postoperative Cognitive Dysfunction-Electroencephalographic-Guided Anesthetic Administration Trial.

Anesth Analg 2021 Oct;133(4):837-847

From the Department of Anesthesiology and Intensive Care Medicine, University Hospital of Besancon, Besancon, France.

Background: The aim of the study was to investigate whether closed-loop compared to manual bispectral index (BIS)-guided target-controlled infusion of propofol and remifentanil could decrease the incidence of postoperative neurocognitive disorders after elective major noncardiac surgery.

Methods: Patients aged >50 admitted for elective major noncardiac surgery were included in a single-blind randomized (ratio 2:1) trial. The anesthetic protocol was allocated by randomization into either closed-loop or manual BIS-guided propofol and remifentanil titration. The BIS target range was 40-60. All patients had cognitive assessment the day before surgery and within 72 hours after surgery using a battery of neuropsychological tests. The primary outcome was the rate of postoperative neurocognitive disorders. Postoperative neurocognitive disorders were defined as a decrease >20% from baseline on at least 3 scores. Intergroup comparison of the primary outcome was performed using the χ2 test.

Results: A total of 143 and 61 patients were included in the closed-loop and manual groups, respectively (age: 66 [8] vs 66 [9] years). The primary outcome was observed in 18 (13%) and 10 (16%) patients of the closed-loop and manual groups, respectively (relative risk [95% confidence interval {CI}], 0.77 [0.38-1.57], P = .47). Intraoperative propofol consumption was lower (4.7 [1.4] vs 5.7 [1.4] mg·kg-1·h-1, mean difference [MD] [95% CI], -0.73 [-0.98 to -0.48], P < .0001) and the proportion of time within the BIS target range higher (84 [77-89] vs 74 [54-81]%, MD [95% CI], 0.94 [0.67-1.21], P < .0001) in the closed-loop group.

Conclusions: Closed-loop compared to manual BIS-guided total intravenous anesthesia provided a significant reduction in episodes of an excessive depth of anesthesia while decreasing intraoperative propofol requirement but no evidence for a reduction of the incidence of postoperative neurocognitive disorders after elective major noncardiac surgery was observed.
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http://dx.doi.org/10.1213/ANE.0000000000005278DOI Listing
October 2021

Neck ultrasound to improve risk assessment for difficult tracheal intubation in the operating room: The TUBECHO case-control prospective observational pilot study.

J Clin Anesth 2021 Feb 15;68:110101. Epub 2020 Oct 15.

Department of Anesthesiology and Intensive Care Medicine, University Hospital of Besancon, Besancon, France; EA 3920, University of Franche-Comte, Besancon, France. Electronic address:

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http://dx.doi.org/10.1016/j.jclinane.2020.110101DOI Listing
February 2021

Elevated D-dimers and lack of anticoagulation predict PE in severe COVID-19 patients.

Eur Respir J 2020 10 22;56(4). Epub 2020 Oct 22.

Dept of Cardiology, University Hospital, Besançon, France.

Background: Coronavirus disease 2019 (COVID-19) may predispose to venous thromboembolism. We determined factors independently associated with computed tomography pulmonary angiography (CTPA)-confirmed pulmonary embolism (PE) in hospitalised severe COVID-19 patients.

Methods: Among all (n=349) patients hospitalised for COVID-19 in a university hospital in a French region with a high rate of COVID-19, we analysed patients who underwent CTPA for clinical signs of severe disease (oxygen saturation measured by pulse oximetry ≤93% or breathing rate ≥30 breaths·min) or rapid clinical worsening. Multivariable analysis was performed using Firth penalised maximum likelihood estimates.

Results: 162 (46.4%) patients underwent CTPA (mean±sd age 65.6±13.0 years; 67.3% male (95% CI 59.5-75.5%). PE was diagnosed in 44 (27.2%) patients. Most PEs were segmental and the rate of PE-related right ventricular dysfunction was 15.9%. By multivariable analysis, the only two significant predictors of CTPA-confirmed PE were D-dimer level and the lack of any anticoagulant therapy (OR 4.0 (95% CI 2.4-6.7) per additional quartile and OR 4.5 (95% CI 1.1-7.4), respectively). Receiver operating characteristic curve analysis identified a D-dimer cut-off value of 2590 ng·mL to best predict occurrence of PE (area under the curve 0.88, p<0.001, sensitivity 83.3%, specificity 83.8%). D-dimer level >2590 ng·mL was associated with a 17-fold increase in the adjusted risk of PE.

Conclusion: Elevated D-dimers (>2590 ng·mL) and absence of anticoagulant therapy predict PE in hospitalised COVID-19 patients with clinical signs of severity. These data strengthen the evidence base in favour of systematic anticoagulation, and suggest wider use of D-dimer guided CTPA to screen for PE in acutely ill hospitalised patients with COVID-19.
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http://dx.doi.org/10.1183/13993003.01811-2020DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7487272PMC
October 2020

COVID-19 patients display distinct SARS-CoV-2 specific T-cell responses according to disease severity.

J Infect 2021 02 25;82(2):282-327. Epub 2020 Aug 25.

Department of Infectious Disease, University Hospital of Besançon, F-25000 Besançon, France; UMR-CNRS 6249 Chrono-Environnement, Université Bourgogne Franche-Comté, F-25000 Besançon, France. Electronic address:

Adaptive Immune responses generated by SARS-CoV-2 virus in convalescent patients according to disease severity remain poorly characterized. To this end, we designed a prospective study (NCT04365322) that included 60 COVID-19 convalescent patients (1-month post infection) in two cohorts respectively entitled mild illness and severe pneumonia. The monitoring of peripheral immune responses was performed using IFNᵧ ELISpot assay. The serology index of each patient was investigated at the same time. Patients with severe pneumonia were older and had more comorbidities than patients with mild illness. T-cell responses in term of frequency and intensity were clearly distinct between mild illness and severe pneumonia patients. Furthermore, our results demonstrated that recent history of COVID-19 did not hamper viral memory T-cell pool against common viruses (Cytomegalovirus, Epstein-Barr-virus and Flu-virus). The presence of potent adaptive immunity even in patients who underwent severe pneumonia sustain the rationale for the development of protective therapeutics against SARS-CoV-2.
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http://dx.doi.org/10.1016/j.jinf.2020.08.036DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7445469PMC
February 2021

Clinical effectiveness of ultrasound-guided dual transversus abdominis plane block for postoperative analgesia in open abdominal aortic surgery patients: The randomised, double-blind ETAP trial.

Eur J Anaesthesiol 2020 09;37(9):821-823

From the Department of Anaesthesiology and Intensive Care Medicine, University Hospital of Besancon (JC, ED, TL, VS, SP-F, ES, GB), EA 3920, Bourgogne Franche-Comte University (LSdM, SP-F, ES, GB), Department of Vascular Surgery (LSdM) and Clinical Methodology Center, University Hospital of Besancon, Besancon, France (MP).

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http://dx.doi.org/10.1097/EJA.0000000000001240DOI Listing
September 2020

Prone Positioning for Severe Acute Respiratory Distress Syndrome in COVID-19 Patients by a Dedicated Team: A Safe and Pragmatic Reallocation of Medical and Surgical Work Force in Response to the Outbreak.

Ann Surg 2020 12;272(6):e311-e315

Department of Digestive Surgical Oncology - Liver Transplant Unit, University Hospital of Besançon, Besançon, France.

Objective: The aim of this study was to define whether rapidly reallocating health care workers not experienced with PP for performing PP in ICU is feasible and safe.

Summary Background Data: In the setting of severe acute respiratory distress syndrome (ARDS), the use of prone and supine positioning procedures (PP) has been associated with improved oxygenation resulting in decreased mortality. Nevertheless, applying PP is time consuming for ICU staffs that are at risk of mental of physical exhaustion, especially with the constant surge of admitted COVID-19 patients with severe ARDS.

Methods: This prospective cohort study conducted at a single regional university hospital between March 27 and April 15, 2020. Among 117 patients admitted to ICU, 67 patients (57.3%) presented with proven SARS-CoV-2 infection with severe ARDS requiring PP. After accelerated simulation training, 109 volunteers including surgeons, physicians, nurses and physiotherapists, multiple dedicated teams performed daily multiple PP following a systematic checklist. Patient demographics and PP data were collected. Patient safety and health care workers safety were assessed.

Results: Among 117 patients admitted to ICU, 67 patients (57.3%) required PP. Overall, 53 (79%) were male, with a median age of 68.5 years and median body mass index of 29.3 kg/m. A total of 384 PP were performed. Overall, complication occurred in 34 PP (8.8%) and led to PP cancelation in 4 patients (1%). Regarding health care workers safety, four health care workers presented with potential COVID-19 related symptoms and none was positive.

Conclusions: To overcome the surge of critically ill COVID-19 patients, reallocating health care workers to targeted medical tasks beyond their respective expertise such as PP was safe.
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http://dx.doi.org/10.1097/SLA.0000000000004265DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7668324PMC
December 2020

Incidence and Outcome of Subclinical Acute Kidney Injury Using penKid in Critically Ill Patients.

Am J Respir Crit Care Med 2020 09;202(6):822-829

Paris University, Paris, France.

Subclinical acute kidney injury (sub-AKI) refers to patients with low serum creatinine but elevated alternative biomarkers of AKI. Its incidence and outcome in critically ill patients remain, however, largely unknown. Plasma proenkephalin A 119-159 (penKid) has been proposed as a sensitive biomarker of glomerular function. In this ancillary study of two cohorts, we explored the incidence and outcome of sub-AKI based on penKid. A prospective observational study in ICUs was conducted. FROG-ICU (French and European Outcome Registry in ICUs) enrolled 2,087 critically ill patients, and AdrenOSS-1 (Adrenomedullin and Outcome in Severe Sepsis and Septic Shock-1) enrolled 583 septic patients. The primary endpoint was 28-day mortality after ICU admission. Sub-AKI was defined by an admission penKid concentration above the normal range (i.e., >80 pmol/L) in patients not meeting the definition of AKI. A sensitivity analysis was performed among patients with estimated glomerular filtration rate above 60 ml/min/1.73 m at ICU admission. In total, 6.1% (122/2,004) and 6.7% (39/583) of patients from the FROG-ICU and AdrenOSS-1 cohorts met the definition of sub-AKI (11.6% and 17.5% of patients without AKI). In patients without AKI or with high estimated glomerular filtration rate, penKid was associated with higher mortality (adjusted standardized hazard ratio [HR], 1.4 [95% confidence interval, 1.1-1.8];  = 0.010; and HR, 1.6 [95% confidence interval, 1.3-1.8];  < 0.0001, respectively) after adjustment for age, sex, comorbidities, diagnosis, creatinine, diuresis, and study. Patients with sub-AKI had higher mortality compared with no AKI (HR, 2.4 [95% confidence interval, 1.5-3.7] in FROG-ICU and 2.5 [95% confidence interval, 1.1-5.9] in AdrenOSS-1). Sub-AKI defined using penKid occurred in 11.6-17.5% of patients without AKI and was associated with a risk of death close to patients with AKI.
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http://dx.doi.org/10.1164/rccm.201910-1950OCDOI Listing
September 2020

Blood glucose control management in critically ill adult patients: Results of a French nationwide practice survey.

Anaesth Crit Care Pain Med 2020 06 21;39(3):447-449. Epub 2020 May 21.

Department of Anaesthesiology and Intensive Care Medicine, University Hospital of Besancon, 3, boulevard Alexander Fleming, 25000 Besancon, France; EA 3920, Bourgogne Franche-Comte University, 3, boulevard Alexander Fleming, 25000 Besancon, France. Electronic address:

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http://dx.doi.org/10.1016/j.accpm.2020.04.017DOI Listing
June 2020

Prone positioning combined with high-flow nasal or conventional oxygen therapy in severe Covid-19 patients.

Crit Care 2020 May 26;24(1):256. Epub 2020 May 26.

Department of Anesthesiology and Intensive Care Medicine, University Hospital of Besancon, University of Franche-Comte, Besancon, France.

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http://dx.doi.org/10.1186/s13054-020-03001-6DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7250283PMC
May 2020

Initial pH and shockable rhythm are associated with favorable neurological outcome in cardiac arrest patients resuscitated with extracorporeal cardiopulmonary resuscitation.

J Thorac Dis 2020 Mar;12(3):849-857

Medical Intensive Care Unit, School of Public Health and Preventive Medicine, Faculty of Medicine, Nursing and Health Sciences, Clayton, Australia.

Background: There is uncertainty about best selection criteria for extracorporeal cardiopulmonary resuscitation (eCPR) in the setting of refractory cardiac arrest. We aimed to identify factors associated with a favorable neurological outcome, and to build a score calculable at the time of ECMO insertion predicting the prognosis.

Methods: Retrospective analysis of all patients who underwent eCPR between 2010 and 2017 in a single university hospital. Primary end point was survival with favorable neurological outcome at intensive care unit (ICU) discharge defined as a Cerebral Performance Category of 1 or 2.

Results: Overall low-flow time of the 113 included patients was 84 [55-122] minutes. Eighteen patients (16%) survived with a favorable neurological outcome. By multivariate logistic regression analysis, initial shockable rhythm, and arterial blood pH at the time of eCPR implantation ≥7.0, were independent predictors of survival with favorable neurological outcome. All of the patients presenting with both non-shockable rhythm and pH <7.0 at the time of eCPR implantation died in the ICU.

Conclusions: At the time of eCPR start, only initial shockable rhythm and arterial pH ≥7.0 predicted neurological outcome. A selection of the patients who might benefit from eCPR, based upon initial rhythm and arterial pH rather than on low flow time, should be further evaluated.
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http://dx.doi.org/10.21037/jtd.2019.12.127DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7139075PMC
March 2020

Liberal or Conservative Oxygen Therapy for Acute Respiratory Distress Syndrome.

N Engl J Med 2020 03;382(11):999-1008

From the Medical Intensive Care Unit (L.B., H.W., L.V., G.C.), the Anesthesia and Intensive Care Unit (L.B., S.P.-F.), Unité de Méthodologie, INSERM Clinical Investigation Center 1431, University Hospital (F. Mauny, M.P.), and Research Unit EA3920, Université de Franche Comté (L.B., H.W. S.P.-F., G.C.), Besançon, the Medical Intensive Care Unit, University Hospital of Angers, Angers (P.A.), the Intensive Care Unit, General Hospital of Avignon, Avignon (F. Montini), the Intensive Care Unit, General Hospital of Nord Franche-Comté, Trévenans (J.B.), the Medical Intensive Care Unit (J.-P.Q.) and the Anesthesia and Intensive Care Unit (B.B.), University Hospital of Dijon, Dijon, the Intensive Care Unit, General Hospital of Metz-Thionville, Metz (G.L.), the Medical Intensive Care Unit (B.S.) and the Anesthesia and Intensive Care Unit (J.-M.C.), University Hospital of Clermont-Ferrand, Clermont-Ferrand, the Anesthesia and Intensive Care Unit, University Hospital of Strasbourg, Strasbourg (O.C., J.P.), and the Medical Intensive Care Unit, University Hospital of Nancy, Nancy (B.L.) - all in France; and the Australian and New Zealand Intensive Care Research Centre, Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, VIC, Australia (G.C.).

Background: In patients with acute respiratory distress syndrome (ARDS), the National Heart, Lung, and Blood Institute ARDS Clinical Trials Network recommends a target partial pressure of arterial oxygen (Pao) between 55 and 80 mm Hg. Prospective validation of this range in patients with ARDS is lacking. We hypothesized that targeting the lower limit of this range would improve outcomes in patients with ARDS.

Methods: In this multicenter, randomized trial, we assigned patients with ARDS to receive either conservative oxygen therapy (target Pao, 55 to 70 mm Hg; oxygen saturation as measured by pulse oximetry [Spo], 88 to 92%) or liberal oxygen therapy (target Pao, 90 to 105 mm Hg; Spo, ≥96%) for 7 days. The same mechanical-ventilation strategies were used in both groups. The primary outcome was death from any cause at 28 days.

Results: After the enrollment of 205 patients, the trial was prematurely stopped by the data and safety monitoring board because of safety concerns and a low likelihood of a significant difference between the two groups in the primary outcome. Four patients who did not meet the eligibility criteria were excluded. At day 28, a total of 34 of 99 patients (34.3%) in the conservative-oxygen group and 27 of 102 patients (26.5%) in the liberal-oxygen group had died (difference, 7.8 percentage points; 95% confidence interval [CI], -4.8 to 20.6). At day 90, 44.4% of the patients in the conservative-oxygen group and 30.4% of the patients in the liberal-oxygen group had died (difference, 14.0 percentage points; 95% CI, 0.7 to 27.2). Five mesenteric ischemic events occurred in the conservative-oxygen group.

Conclusions: Among patients with ARDS, early exposure to a conservative-oxygenation strategy with a Pao between 55 and 70 mm Hg did not increase survival at 28 days. (Funded by the French Ministry of Health; LOCO ClinicalTrials.gov number, NCT02713451.).
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http://dx.doi.org/10.1056/NEJMoa1916431DOI Listing
March 2020

One-Year Prognosis of Kidney Injury at Discharge From the ICU: A Multicenter Observational Study.

Crit Care Med 2019 12;47(12):e953-e961

Department of Anaesthesiology, Critical Care Medicine and Burn unit, AP-HP, Saint Louis and Lariboisière University Hospitals, Paris, France.

Objectives: The association between outcome and kidney injury detected at discharge from the ICU using different biomarkers remains unknown. The objective was to evaluate the association between 1-year survival and kidney injury at ICU discharge.

Design: Ancillary investigation of a prospective observational study.

Setting: Twenty-one ICUs with 1-year follow-up.

Patients: Critically ill patients receiving mechanical ventilation and/or hemodynamic support for at least 24 hours were included.

Interventions: Serum creatinine, plasma Cystatin C, plasma neutrophil gelatinase-associated lipocalin, urinary neutrophil gelatinase-associated lipocalin, plasma Proenkephalin A 119-159, and estimated glomerular filtration rate (on serum creatinine and plasma Cystatin C) were measured at ICU discharge among ICU survivors.

Measurements And Main Results: The association between kidney biomarkers at discharge and mortality was estimated using logistic model with and without adjustment for prognostic factors previously identified in this cohort. Subgroup analyses were performed in patients with discharge serum creatinine less than 1.5-fold baseline at ICU discharge. Among 1,207 ICU survivors included, 231 died during the year following ICU discharge (19.2%). Estimated glomerular filtration rate was significantly lower and kidney injury biomarkers higher at discharge in nonsurvivors. The association between biomarker levels or estimated glomerular filtration rate and mortality remained after adjustment to potential cofounding factors influencing outcome. In patients with low serum creatinine at ICU discharge, 25-47% of patients were classified as subclinical kidney injury depending on the biomarker. The association between kidney biomarkers and mortality remained and mortality was higher than patients without subclinical kidney injury. The majority of patients who developed acute kidney injury during ICU stay had elevated biomarkers of kidney injury at discharge even with apparent recovery based on serum creatinine (i.e., subclinical acute kidney disease).

Conclusions: Elevated kidney biomarkers measured at ICU discharge are associated with poor 1-year outcome, including in patients with low serum creatinine at ICU discharge.
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http://dx.doi.org/10.1097/CCM.0000000000004010DOI Listing
December 2019

Long-term mortality and quality of life after trauma: an ancillary study from the prospective multicenter trial FROG-ICU.

Eur J Trauma Emerg Surg 2021 Apr 18;47(2):461-466. Epub 2019 Jun 18.

Service d'Anesthésie et de Réanimation, Hôpital Nord, Aix Marseille Université, Assistance Publique Hôpitaux de Marseille, Marseille, France.

Introduction: The long-term outcomes of intensive care unit (ICU) patients are known to be worse than those of the general population, but they are poorly known in severe trauma patients. We conducted an ancillary examination of the FROG-ICU study to identify risk factors and biomarkers associated with the poorer long-term outcomes and mortality in trauma ICU patients.

Methods: Mortality, quality of life (QoL) and stress level scores were obtained 1 year after discharge from ICU. Blood samples were collected at ICU admission and discharge for measurement of inflammatory and cardiovascular biomarkers.

Results: ICU trauma patients had a significantly lower 1-year mortality than non-trauma patients (7% vs. 23%, p < 0.001), but had worse stress levels scores (19 vs. 13, p = 0.041). No difference was found regarding physical and mental QoL scores (33 vs. 31, p = 0.19 and 30 vs. 28, p = 0.42). Patients with better QoL scores had lower tracheotomy rates (11% vs. 30%, p = 0.01). Worse stress level scores are associated with poor QoL scores and vice versa. Some study biomarkers were significantly higher in those ICU trauma patients who had worse QoL scores at 1 year after discharge.

Discussion: Our study suggests that quality of life 1 year after an ICU stay is poor and is similar in both trauma and non-trauma patients, but ICU trauma patients are at greater risk of developing post-traumatic stress disorder-related symptoms. Tracheotomy and high levels of inflammatory biomarkers could be associated with impaired quality of life.
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http://dx.doi.org/10.1007/s00068-019-01176-4DOI Listing
April 2021

Impact of post-procedural glycemic variability on cardiovascular morbidity and mortality after transcatheter aortic valve implantation: a post hoc cohort analysis.

Cardiovasc Diabetol 2019 03 11;18(1):27. Epub 2019 Mar 11.

EA3920, University of Franche-Comte, 25000, Besancon, France.

Background: Glycemic variability is associated with worse outcomes after cardiac surgery, but the prognosis value of early glycemic variability after transcatheter aortic valve implantation is not known. This study was therefore designed to analyze the prognosis significance of post-procedural glycemic variability within 30 days after transcatheter aortic valve implantation.

Methods: A post hoc analysis of patients from our center included in the FRANCE and FRANCE-2 registries was conducted. Post-procedural glycemic variability was assessed by calculating the mean daily δ blood glucose during the first 2 days after transcatheter aortic valve implantation. Major complications within 30 days were death, stroke, myocardial infarction, acute heart failure, and life-threatening cardiac arrhythmias.

Results: We analyzed 160 patients (age (median [interquartile] = 84 [80-88] years; diabetes mellitus (n) = 41 (26%) patients; logistic Euroscore = 20 [12-32]). The median value of mean daily δ blood glucose was 4.3 mmol l. The rate of major complications within 30 days after procedure among patients with the lowest quartile of glycemic variability was 12%, increasing from 12 to 26%, and 39% in the second, third, and fourth quartiles, respectively. In multivariate analysis, glycemic variability was independently associated with an increased risk of major complications within 30 days after the procedure (odds ratio [95% CI] = 1.83 [1.19-2.83]; p = 0.006).

Conclusions: This study showed that post-procedural glycemic variability was associated with an increased risk of major complications within 30 days after transcatheter aortic valve implantation. Trial registration Clinical trial registration number https://www.clinicaltrials.gov/ ; identifier: NCT02726958; date: April 4th, 2016.
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http://dx.doi.org/10.1186/s12933-019-0831-3DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6410509PMC
March 2019

Effect of age of transfused red blood cells on neurologic outcome following traumatic brain injury (ABLE-tbi Study): a nested study of the Age of Blood Evaluation (ABLE) trial.

Can J Anaesth 2019 06 26;66(6):696-705. Epub 2019 Feb 26.

CHU de Québec - Université Laval Research Centre, Population Health and Optimal Health Practices Research Unit, Trauma - Emergency - Critical Care Medicine, Université Laval, Quebec City, QC, Canada.

Background: Anemia is common in critically ill patients with traumatic brain injury, and often requires red blood cell transfusion. Studies suggest that prolonged storage causes lesions of the red blood cells, including a decreased ability to carry oxygen. Considering the susceptibility of the brain to hypoxemia, victims of traumatic brain injury may thus be more vulnerable to exposure to older red blood cells.

Methods: Our study aimed to ascertain whether the administration of fresh red blood cells (seven days or less) results in a better neurologic outcome compared with standard red blood cells in critically ill patients with traumatic brain injury requiring transfusion. The Age of Blood Evaluation in traumatic brain injury (ABLE-tbi) study was a nested study within the ABLE study (ISRCTN44878718). Our primary outcome was the extended Glasgow Outcome Scale (GOSe) at six months.

Results: In the ABLE study, 217 subjects suffered a traumatic brain injury: 110 in the fresh group, and 107 in the standard group. In the fresh group, 68 (73.1%) of the patients had an unfavourable neurologic outcome (GOSe ≤ 4) compared with 60 (64.5%) in the standard group (P = 0.21). Using a sliding dichotomy approach, we observed no overall effect of fresh red blood cells on neurologic outcome (odds ratio [OR], 1.34; 95% confidence interval [CI], 0.72 to 2.50; P = 0.35) but observed differences across prognostic bands with a decreased odds of unfavourable outcome in patients with the best prognosis at baseline (OR, 0.33; 95% CI, 0.11 to 0.96; P = 0.04) but an increased odds in those with intermediate and worst baseline prognosis (OR, 5.88; 95% CI,1.66 to 20.81; P = 0.006; and OR, 1.67; 95% CI, 0.53 to 5.30; P = 0.38, respectively).

Conclusion: Overall, transfusion of fresh red blood cells was not associated with a better neurologic outcome at six months in critically ill patients with traumatic brain injury. Nevertheless, we cannot exclude a differential effect according to the patient baseline prognosis.

Trial Registration: ABLE study (ISRCTN44878718); registered 22 August, 2008.
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http://dx.doi.org/10.1007/s12630-019-01326-7DOI Listing
June 2019

Clinical effectiveness of single dose of intravenous dexamethasone on the duration of ropivacaine axillary brachial plexus block: the randomized placebo-controlled ADEXA trial.

Reg Anesth Pain Med 2019 03;44(3)

Department of Anesthesiology and Intensive Care Medicine, University Hospital of Besancon, Bourgogne Franche-Comte University, Besancon, France.

Background And Objectives: The effect of intravenous dexamethasone on the duration of axillary plexus block performed using ropivacaine is not described. The aim of this study is to assess the effect of intravenous dexamethasone on the duration of axillary plexus block analgesia after distal upper arm surgery.

Methods: In this prospective, randomized, placebo-controlled, double-blinded trial, consenting patients scheduled for hand or forearm surgery under ultrasound-guided axillary plexus block performed using 0.5 mL/kg of 0.475% ropivacaine, were randomized to receive an intravenous injection of either 8 mg/2 mL of dexamethasone (Dexa group) or 2 mL of saline (Control). The primary outcome was the time of first analgesic intake after axillary block. Secondary outcomes included motor or sensory block duration, total use of postoperative analgesics, and block-related complications.

Results: Among the 98 patients included, 6 and 2 patients did not require postoperative analgesic intake in Dexa and Control groups, respectively (p=0.06). The time of first analgesic intake was significantly longer in the Dexa (20.9±9.3 hours) than in the Control group (14.7±6.6 hours, p<0.0004). Motor and sensory recovery occurred significantly later, and total analgesic consumption was lower in the Dexa than in the Control group. No nerve complication related to intravenous dexamethasone injection was recorded.

Conclusions: This study showed that intravenous dexamethasone delayed for 6 hours the time to first analgesic intake after upper arm surgery under axillary plexus block performed with the long-lasting local anesthetic ropivacaine. This suggests that intravenous dexamethasone could be an interesting adjuvant to axillary plexus block.

Trial Registration Number: NCT02862327.
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http://dx.doi.org/10.1136/rapm-2018-100035DOI Listing
March 2019

Impact of intravenous exenatide infusion for perioperative blood glucose control on myocardial ischemia-reperfusion injuries after coronary artery bypass graft surgery: sub study of the phase II/III ExSTRESS randomized trial.

Cardiovasc Diabetol 2018 11 1;17(1):140. Epub 2018 Nov 1.

Department of Anesthesiology and Intensive Care Medicine, University Hospital of Besancon, and, EA3920 and SFR-FED 4234 INSERM, University of Franche-Comte, 3 bvd Alexander Fleming, 25000, Besançon, France.

Background: The aim of the study was to investigate whether intravenous (iv) infusion of exenatide, a synthetic GLP-1 receptor agonist, could provide a protective effect against myocardial ischemia-reperfusion injury after coronary artery bypass graft (CABG) surgery.

Methods: A sub study analysis of patients > 18 years admitted for elective CABG and included in the ExSTRESS trial was conducted. Patients were randomized to receive either iv exenatide (1-h bolus of 0.05 µg min followed by a constant infusion of 0.025 µg min) (exenatide group) or iv insulin therapy (control group) for blood glucose control (target range 100-139 mg dl) during the first 48 h after surgical incision. All serum levels of troponin I measured during routine care in the Cardiac Surgery ICU were recorded. The primary outcome was the highest value of plasma concentration of troponin I measured between 12 and 24 h after ICU admission. The proportion of patients presenting an echocardiographic left ventricular ejection fraction (LVEF) > 50% at the follow-up consultation was compared between the two groups.

Results: Finally, 43 and 49 patients were analyzed in the control and exenatide groups, respectively {age: 69 [61-76] versus 71 [63-75] years; baseline LVEF < 50%: 6 (14%) versus 16 (32%) patients; on-pump surgery: 29 (67%) versus 33 (67%) patients}. The primary outcome did not significantly differ between the two groups (3.34 [1.06-6.19] µg l versus 2.64 [1.29-3.85] µg l in the control and exenatide groups, respectively; mean difference (MD) [95% confidence interval (95% CI)] 0.16 [- 0.25; 0.57], p = 0.54). The highest troponin value measured during the first 72 h in the ICU was 6.34 [1.36-10.90] versus 5.04 [2.39-7.18] µg l, in the control and exenatide groups respectively (MD [95% CI] 0.20 [- 0.22; 0.61], p = 0.39). At the follow-up consultation, 5 (12%) versus 8 (16%) patients presented a LVEF < 50% in the control and in the exenatide groups respectively (relative risk [95% CI] 0.68 [0.16; 2.59], p = 0.56).

Conclusions: Postoperative iv exenatide did not provide any additional cardioprotective effect compared to iv insulin in low-risk patients undergoing scheduled CABG surgery. Trial registration ClinicalTrials.gov Identifier NCT01969149, date of registration: January 7th, 2015; EudraCT No. 2009-009254-25 A, date of registration: January 6th, 2009.
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http://dx.doi.org/10.1186/s12933-018-0784-yDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6211400PMC
November 2018

Effect of Early Sustained Prophylactic Hypothermia on Neurologic Outcomes Among Patients With Severe Traumatic Brain Injury: The POLAR Randomized Clinical Trial.

JAMA 2018 12;320(21):2211-2220

Australian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, Victoria, Australia.

Importance: After severe traumatic brain injury, induction of prophylactic hypothermia has been suggested to be neuroprotective and improve long-term neurologic outcomes.

Objective: To determine the effectiveness of early prophylactic hypothermia compared with normothermic management of patients after severe traumatic brain injury.

Design, Setting, And Participants: The Prophylactic Hypothermia Trial to Lessen Traumatic Brain Injury-Randomized Clinical Trial (POLAR-RCT) was a multicenter randomized trial in 6 countries that recruited 511 patients both out-of-hospital and in emergency departments after severe traumatic brain injury. The first patient was enrolled on December 5, 2010, and the last on November 10, 2017. The final date of follow-up was May 15, 2018.

Interventions: There were 266 patients randomized to the prophylactic hypothermia group and 245 to normothermic management. Prophylactic hypothermia targeted the early induction of hypothermia (33°C-35°C) for at least 72 hours and up to 7 days if intracranial pressures were elevated, followed by gradual rewarming. Normothermia targeted 37°C, using surface-cooling wraps when required. Temperature was managed in both groups for 7 days. All other care was at the discretion of the treating physician.

Main Outcomes And Measures: The primary outcome was favorable neurologic outcomes or independent living (Glasgow Outcome Scale-Extended score, 5-8 [scale range, 1-8]) obtained by blinded assessors 6 months after injury.

Results: Among 511 patients who were randomized, 500 provided ongoing consent (mean age, 34.5 years [SD, 13.4]; 402 men [80.2%]) and 466 completed the primary outcome evaluation. Hypothermia was initiated rapidly after injury (median, 1.8 hours [IQR, 1.0-2.7 hours]) and rewarming occurred slowly (median, 22.5 hours [IQR, 16-27 hours]). Favorable outcomes (Glasgow Outcome Scale-Extended score, 5-8) at 6 months occurred in 117 patients (48.8%) in the hypothermia group and 111 (49.1%) in the normothermia group (risk difference, 0.4% [95% CI, -9.4% to 8.7%]; relative risk with hypothermia, 0.99 [95% CI, 0.82-1.19]; P = .94). In the hypothermia and normothermia groups, the rates of pneumonia were 55.0% vs 51.3%, respectively, and rates of increased intracranial bleeding were 18.1% vs 15.4%, respectively.

Conclusions And Relevance: Among patients with severe traumatic brain injury, early prophylactic hypothermia compared with normothermia did not improve neurologic outcomes at 6 months. These findings do not support the use of early prophylactic hypothermia for patients with severe traumatic brain injury.

Trial Registration: clinicaltrials.gov Identifier: NCT00987688; Anzctr.org.au Identifier: ACTRN12609000764235.
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http://dx.doi.org/10.1001/jama.2018.17075DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6583488PMC
December 2018

Association of social deprivation with 1-year outcome of ICU survivors: results from the FROG-ICU study.

Intensive Care Med 2018 12 23;44(12):2025-2037. Epub 2018 Oct 23.

Department of Anaesthesiology and Reanimation, Burn and Critical Care Medicine, AP-HP, Saint Louis and Lariboisière University Hospitals, 2 Rue Ambroise Paré, 75010, Paris, France.

Purpose: Intensive care unit survivors suffer from prolonged impairment, reduced quality of life, and higher mortality rates after discharge compared to the general population. Socioeconomic status may play a partial but important role in mortality and recovery. Therefore, the detection of factors that are responsible for poor long-term outcomes would be beneficial in designing targeted interventions for at-risk populations.

Methods: For an endpoint analysis, 1834 intensive care unit patients with known French Deprivation Index (FDep) scores were included from the French and euRopean Outcome reGistry in Intensive Care Units (FROG-ICU) study, which was a prospective, observational, multicenter cohort study performed in 20 French intensive care units in 13 different hospitals. Socioeconomic status was defined by using the FDep score [represented as quintiles when referring to the general French population, as quintiles when referring to the FROG-ICU cohort, or as dichotomized data (which was defined as a FDep ≤ 0 for nondeprived patients)] and by using a detailed social questionnaire that was completed 3 months after discharge. The primary outcome included an all-cause, 1-year mortality after ICU discharge when regarding socioeconomic status. The secondary outcomes included both ICU and hospital lengths of stay, both short- and medium-term mortality, and the quality of life, as assessed during the 1-year follow-up by using the Medical Outcome Survey Short Form-36 (SF-36). The Revised Impact of Event Scale (IES-R) was used to evaluate the symptoms of post-traumatic stress disorder, and the Hospital Anxiety and Depression Scale (HADS) was used to screen for anxiety and depression.

Results: Of the 1447 patients who were discharged alive from the ICU, 19.2% died over the following year. No association was found between 1-year mortality and socioeconomic status, regardless of whether this association was analyzed in quintiles (p = 0.911 in the quintiles of the general French population; p = 0.589 in the quintiles of the FROG-ICU cohort itself) or as dichotomized data [nondeprived (n = 177; 1-year mortality of 18.2%) versus deprived (n = 97; 1-year mortality of 20.5%; p = 0.304)]. Moreover, no differences were found between the nondeprived and the deprived patients in the ICU and hospital lengths of stay, ICU mortalities, in-hospital mortalities, or 28-day mortalities. The SF-36 was below the score for the normal French population throughout the follow-up period. Socially deprived patients showed significantly lower median scores in the physical function subscale [55, interquartile range (IQR) (28.8-80) vs. 65, IQR (35-90); p = 0.014], the physical role subscale [25, IQR (0-75) vs. 33.3, IQR (0-100); p = 0.022], and the overall physical component scale [47.5, IQR (30-68.8) vs. 54.4, IQR (35-78.8); p = 0.010]. Up to 31.6% of survivors presented symptoms that indicated post-traumatic stress disorder, and up to 31.5% of survivors reported clinically meaningful symptoms of anxiety or depression.

Conclusions: A lower socioeconomic status was associated with lower self-reported physical component scores in the nondeprived patients. Psychiatric symptoms are frequently reported after an ICU stay, and subsequent interventions should target those fields.

Trial Registration: ClinicalTrials.gov NCT01367093; registered on June 6, 2011.
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http://dx.doi.org/10.1007/s00134-018-5412-5DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7095041PMC
December 2018
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