CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 191 enrolled
Drug / intervention
Stress-dose hydrocortisonedrug
Likely dose
Stress-dose hydrocortisone 300 mgfrom record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02408939
NCT02408939N/ACompleted

Effect of Stress-dose Steroids on Post-resuscitation Infectious (Septic) Complications After In-hospital Cardiac Arrest. Individual Patient Data-based Re-analysis of Synthesized Prior Randomized Clinical Trial Data

University of Athens·observational·Posted Apr 6, 2015·Updated Jan 17, 2024

In Brief

An observational study evaluating Stress-dose hydrocortisone for Infections and Cardiac Arrest. Completed, enrolled 191 participants across 5 sites in 2 countries.

Detailed Summary

Postresuscitation disease is characterized by post-insult systemic inflammation, adrenal insufficiency, and circulatory failure. Such severe pathology may be associated with increased susceptibility to infectious complications and increased risk of death due to postresuscitation septic shock. The latter may be attenuated by stress-dose steroids. In this re-analysis of synthesized randomized clinical trial (RCT) data, the investigators will use individual patient data from two prior RCTs of in-hospital cardiac arrest (NCT00411879 \& NCT00729794), in order to determine the effect of stress-dose steroids on the severity of postresuscitation infectious complications, and more specifically, on the risk of septic shock-associated death.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesFrance, Greece

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedApr 6, 2015
Enrollment StartMar 1, 2015
Primary CompletionAug 1, 2015
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 11.2 years ago

Interventions

Stress-dose hydrocortisonedrug

Patients with postresuscitation shock received stress-dose (300 mg) of hydrocortisone for 7 days maximum followed by gradual taper and discontinuation over 48 hours after either the resolution of their hemodynamic instability or day 7 of treatment.