for the Atlanrea Study Group and the Société Française d'Anesthésie Réanimation (SFAR) Research Network IMPORTANCE Fluid therapy is an important component of care for patients with traumatic brain injury, but whether it modulates clinical outcomes remains unclear.OBJECTIVE To determine whether continuous infusion of hypertonic saline solution improves neurological outcome at 6 months in patients with traumatic brain injury. DESIGN, SETTING, AND PARTICIPANTSMulticenter randomized clinical trial conducted in 9 intensive care units in France, including 370 patients with moderate to severe traumatic brain injury who were recruited from October 2017 to August 2019. Follow-up was completed in February 2020.INTERVENTIONS Adult patients with moderate to severe traumatic brain injury were randomly assigned to receive continuous infusion of 20% hypertonic saline solution plus standard care (n = 185) or standard care alone (controls; n = 185). The 20% hypertonic saline solution was administered for 48 hours or longer if patients remained at risk of intracranial hypertension. MAIN OUTCOMES AND MEASURESThe primary outcome was Extended Glasgow Outcome Scale (GOS-E) score (range, 1-8, with lower scores indicating worse functional outcome) at 6 months, obtained centrally by blinded assessors and analyzed with ordinal logistic regression adjusted for prespecified prognostic factors (with a common odds ratio [OR] >1.0 favoring intervention). There were 12 secondary outcomes measured at multiple time points, including development of intracranial hypertension and 6-month mortality. RESULTS Among 370 patients who were randomized (median age, 44 [interquartile range, 27-59] years; 77 [20.2%] women), 359 (97%) completed the trial. The adjusted common OR for the GOS-E score at 6 months was 1.02 (95% CI, 0.71-1.47; P = .92). Of the 12 secondary outcomes, 10 were not significantly different. Intracranial hypertension developed in 62 (33.7%) patients in the intervention group and 66 (36.3%) patients in the control group (absolute difference, −2.6% [95% CI, −12.3% to 7.2%]; OR, 0.80 [95% CI, 0.51-1.26]). There was no significant difference in 6-month mortality (29 [15.9%] in the intervention group vs 37 [20.8%] in the control group; absolute difference, −4.9% [95% CI, −12.8% to 3.1%]; hazard ratio, 0.79 [95% CI, 0.48-1.28]).CONCLUSIONS AND RELEVANCE Among patients with moderate to severe traumatic brain injury, treatment with continuous infusion of 20% hypertonic saline compared with standard care did not result in a significantly better neurological status at 6 months. However, confidence intervals for the findings were wide, and the study may have had limited power to detect a clinically important difference.
Background We determined whether an audit on the adherence to guidelines for hospital-acquired pneumonia (HAP) for can improve the outcomes of patients in intensive care units (ICUs). Methods This study was conducted at 35 ICUs in 30 hospitals. We included consecutive adult patients hospitalized in ICUs for three days or more. After a three-month baseline period followed by the dissemination of recommendations, an audit on the compliance to recommendations (audit period) was followed by a three-month cluster-randomized trial. We randomly assigned ICUs to either audit and feedback (intervention group) or participation to a national registry (control group). The primary outcome was the duration of ICU stay. Results Among 1,856 patients enrolled, 602, 669, and 585 were recruited in the baseline, audit, and intervention periods, respectively. The composite measure of compliance was 47(38-56)% in the intervention group and 42(25-53)% in the control group (p=0.001). As compared to the baseline period, the ICU length of stay was reduced by 3.2 days in the intervention group (p=0.07) and by 2.8 days in the control group (p=0.02). The duration of ICU stay was 7 (5–14) in the control group and 9 (5–20) days in the intervention group (p=0.10). After adjustment for unbalanced baseline characteristics, the hazard ratio for being discharged alive from ICU in the control group was 1.17 (95% CI, 0.69 to 2.01; p=0.10). Conclusions The publication of French guidelines for HAP was associated with a reduction of the ICU length of stay. However, the realization of an audit to improve their application did not further improve outcomes.
Objectives: To describe early electrocardiogram (ECG) abnormalities after status epilepticus (SE) and evaluate their association with 90-day neurological outcomes. Design: Retrospective analysis of a multicenter, national prospective registry between February 2018 and June 2020. Setting: Sixteen ICUs in France, IctalGroup Research Network. Patients: Adults with available ECG performed less than or equal to 24 hours after the onset of SE and less than or equal to 12 hours after its resolution. Intervention: Double-blinded review of all ECGs was performed by two independent cardiologists. ECGs were categorized as normal/abnormal and then with minor/major early ECG abnormalities according to the Novacode ECG Classification system. Measurements and Main Results: Among 155 critically ill patients with SE, early ECG abnormalities were encountered in 145 (93.5%), categorized as major in 91 of 145 (62.8%). In addition to sinus tachycardia, the main abnormalities were in the ST segment (elevation [16.6%] or depression [17.9%]) or negative T waves (42.1%). Major early ECG abnormalities were significantly associated with respiratory distress and sinus tachycardia at the scene and hyperlactatemia at ICU admission. By multivariable analysis, three variables were significantly associated with 90-day poor outcome: age, preexisting ultimately fatal comorbidity, and cerebral insult as the cause of SE. Early major ECG abnormalities were not independently associated with 90-day functional outcome. Conclusions: In our study, early ECG abnormalities in the acute phase of SE were frequent, often unrecognized and were associated with clinical and biological stigma of hypoxemia. Although they were not independently associated with 90-day functional outcome, ECG changes at the early stage of SE should be systematically evaluated. TRIAL REGISTRATION: https://clinicaltrials.gov/ct2/show/NCT03457831.
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