Journal of critical care
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Journal of critical care · Oct 2024
Randomized Controlled TrialEchocardiography predictors of sustained sinus rhythm after cardioversion of supraventricular arrhythmia in patients with septic shock.
The echocardiography parameters may predict the maintenance of sinus rhythm after cardioversion of a supraventricular arrhythmia (SVA). ⋯ The LA_EF and Avti are related to arrhythmia recurrences post-cardioversion suggesting potential guidance to the choice between rhythm and rate control strategies.
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Journal of critical care · Aug 2024
Randomized Controlled Trial Multicenter StudyHierarchical endpoints in critical care: A post-hoc exploratory analysis of the standard versus accelerated initiation of renal-replacement therapy in acute kidney injury and the intensity of continuous renal-replacement therapy in critically ill patients trials.
To perform a post-hoc reanalysis of the Standard versus Accelerated Initiation of Renal-Replacement Therapy in Acute Kidney Injury (STARRT-AKI) and the Intensity of Continuous Renal-Replacement Therapy in Critically Ill Patients (RENAL) trials through hierarchical composite endpoint analysis using win ratio (WR). ⋯ WR approach using a hierarchical composite endpoint is feasible for trials in critical care nephrology. The primary re-analyses of the STARRT-AKI and RENAL trials both yielded neutral results; however, there was suggestion of heterogeneity in treatment effect in stratified analyses of the STARRT-AKI trial by surgical status and sepsis. Selection of the endpoints and hierarchical ordering before trial design using the WR approach can have important implications for trial interpretation.
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Journal of critical care · Jun 2024
Randomized Controlled TrialImmunologic effect and clinical impact of erythromycin in septic patients: A randomized clinical trial.
To investigate the potential regulatory effect of erythromycin added to standard care in septic patients on sepsis biomarkers and clinical outcome. It was a single-blind randomized trial including critical septic patients. The primary endpoint was the change in the TNF/IL-10 ratio between days 0 and 6. ⋯ Serum Procalcitonin (PCT) and CRP dropped considerably in the Erythromycin group, whereas only PCT showed a drop in the placebo group. On day 6, the non-survivors' serum TNF/IL-10 ratio was lower than that of the survivors (0.55 [0.17-1.04] vs 1.08 [0.4-2.28], p = 0.029). Neither the pro/anti-inflammatory imbalance nor the mortality were impacted by the addition of erythromycin to standard care in septic patients (ClinicalTrials.gov ID: NCT04665089 (11/12/2020)).
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Journal of critical care · Apr 2024
Randomized Controlled TrialEarly prediction of sepsis in intensive care patients using the machine learning algorithm NAVOY® Sepsis, a prospective randomized clinical validation study.
To prospectively validate, in an ICU setting, the prognostic accuracy of the sepsis prediction algorithm NAVOY® Sepsis which uses 4 h of input for routinely collected vital parameters, blood gas values, and lab values. ⋯ The accuracy, sensitivity, and specificity were all high, validating the prognostic accuracy of NAVOY® Sepsis in an ICU setting, including Covid-19 patients.
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Journal of critical care · Feb 2024
Randomized Controlled Trial Multicenter StudyThe safety and efficacy of stem cells for the treatment of severe community-acquired bacterial pneumonia: A randomized clinical trial.
Evaluate the safety profile of expanded allogeneic adipose-derived mesenchymal stem cell (eASC) for the treatment of severe community-acquired bacterial pneumonia (CABP). ⋯ Cx611 was well tolerated in severe CABP. These data provide insights for future stem cell clinical study designs, endpoints and sample size calculation.