Arterial Pressure and Stress-Dose Steroids in In-hospital Cardiac Arrest: a Mediation Analysis of Prior Randomized Clinical Trial Data.

NCT02785224 WITHDRAWN

Early stress-dose steroids are of uncertain efficacy in cardiac arrest. The current authors plan to conduct a pertinent mediation analysis using prospectively collected data from 2 prior randomized clinical trials of in-hospital cardiac arrest. These trials reported positive results on the vasopressin-steroids-epinephrine (VSE) combination. The current analysis is aimed at identifying mediators of the benefit associated with VSE, potentially attributable to its stress-dose steroid subcomponent. Tested mediators will include arterial pressure in the early postresuscitation period (primary), and arterial blood lactate in the early postresuscitation period and renal failure free days (secondary).

Details

Lead sponsor	University of Athens
Status	WITHDRAWN
Start date	2025-12
Completion	2026-12

Conditions

• Cardiac Arrest

Interventions

• Vasopressin Steroids Epinephrine

Primary outcomes

• Early postresuscitation systolic arterial pressure (SAP) as mediator of observed intervention benefit. — 20 min after return of spontaneous circulation (ROSC)
  Determination of the possible mediating role of SAP with respect to the observed vasopressin-steroids-epinephrine (VSE) outcome benefit. Multivariable mediation analysis of the following possible relationship: VSE intervention - postresuscitation SAP\>90 mmHg at 20 min post-ROSC - Survival with good neurological recovery i.e. Cerebral Performance Category (CPC) score of 1 or 2.This will result in the primary mediation analysis "SAP" model.
• Early postresuscitation mean arterial pressure (MAP) as mediator of observed intervention benefit — 24 hours after ROSC
  Determination of the possible mediating role of MAP with respect to the observed VSE outcome benefit. Multivariable mediation analysis of the following possible relationship: VSE intervention - at least 1 day-1 postrandomization MAP value\>80 mmHg - Survival with good neurological recovery i.e. CPC score of 1 or 2. This will result in the primary mediation analysis "MAP" model.

Countries

Greece