Critical care : the official journal of the Critical Care Forum
-
Randomized Controlled Trial Multicenter Study
Efficacy and safety of baricitinib in hospitalized adults with severe or critical COVID-19 (Bari-SolidAct): a randomised, double-blind, placebo-controlled phase 3 trial.
Baricitinib has shown efficacy in hospitalized patients with COVID-19, but no placebo-controlled trials have focused specifically on severe/critical COVID, including vaccinated participants. ⋯ This clinical trial was prematurely stopped for external evidence and therefore underpowered to conclude on a potential survival benefit of baricitinib in severe/critical COVID-19. We observed a possible safety signal in vaccinated participants, who were older with more comorbidities. Although based on a post-hoc analysis, these findings warrant further investigation in other trials and real-world studies. Trial registration Bari-SolidAct is registered at NCT04891133 (registered May 18, 2021) and EUClinicalTrials.eu ( 2022-500385-99-00 ).
-
Randomized Controlled Trial Multicenter Study
Valproic acid as adjuvant treatment for convulsive status epilepticus: a randomised clinical trial.
Generalised convulsive status epilepticus (GCSE) is a medical emergency. Guidelines recommend a stepwise strategy of benzodiazepines followed by a second-line anti-seizure medicine (ASM). However, GCSE is uncontrolled in 20-40% patients and is associated with protracted hospitalisation, disability, and mortality. The objective was to determine whether valproic acid (VPA) as complementary treatment to the stepwise strategy improves the outcomes of patients with de novo established GCSE. ⋯ VPA added to the recommended strategy for adult GCSE is well tolerated but did not increase the proportion of patients hospital-discharged by day 15.
-
Randomized Controlled Trial
Effect of high-flow oxygen versus T-piece ventilation strategies during spontaneous breathing trials on weaning failure among patients receiving mechanical ventilation: a randomized controlled trial.
A spontaneous breathing trial (SBT) is used to determine whether patients are ready for extubation, but the best method for choosing the SBT strategy remains controversial. We investigated the effect of high-flow oxygen versus T-piece ventilation strategies during SBT on rates of weaning failure among patients receiving mechanical ventilation. ⋯ Among patients receiving mechanical ventilation, high-flow oxygen SBT did not significantly reduce the risk of weaning failure compared with T-piece SBT. However, the study may have been underpowered to detect a clinically important treatment effect for the comparison of high-flow oxygen SBT versus T-piece SBT, and a higher percentage of patients with simple weaning and a lower weaning failure rate than expected should be considered when interpreting the findings. Clinical trial registration This trial was registered with ClinicalTrials.gov (number NCT03929328) on April 26, 2019.
-
Randomized Controlled Trial
Non-interventional follow-up versus fluid bolus in RESPONSE to oliguria in hemodynamically stable critically ill patients: a randomized controlled pilot trial.
Fluid bolus therapy is a common intervention to improve urine output. Data concerning the effect of a fluid bolus on oliguria originate mainly from observational studies and remain controversial regarding the actual benefit of such therapy. We compared the effect of a follow-up approach without fluid bolus to a 500 mL fluid bolus on urine output in hemodynamically stable critically ill patients with oliguria at least for 2 h (urine output < 0.5 mL/kg/h) in randomized setting. ⋯ Follow-up approach to oliguria compared to administering a fluid bolus of 500 mL crystalloid in oliguric patients improved urine output less frequently but lead to lower cumulative fluid balance. Trial registration clinical.
-
Randomized Controlled Trial
Ultra-lung-protective ventilation and biotrauma in severe ARDS patients on veno-venous extracorporeal membrane oxygenation: a randomized controlled study.
Ultra-lung-protective ventilation may be useful during veno-venous extracorporeal membrane oxygenation (vv-ECMO) for severe acute respiratory distress syndrome (ARDS) to minimize ventilator-induced lung injury and to facilitate lung recovery. The objective was to compare pulmonary and systemic biotrauma evaluated by numerous biomarkers of inflammation, epithelial, endothelial injuries, and lung repair according to two ventilator strategies on vv-ECMO. ⋯ gov ( NCT03918603 ). Registered 17 April 2019.