CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 40 enrolled
Drug / intervention
Hydrocortisone +1 moredrug
Likely dose
Hydrocortisone 50mg/m2from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01595386
NCT01595386N/ACompleted
CompareCT.gov

Effect of Postoperative Hydrocortisone on Cardiovascular and Respiratory Function in Neonates Undergoing Cardiopulmonary Bypass

University of Alabama at Birmingham·interventional·Posted May 10, 2012·Updated Nov 10, 2015

In Brief

A clinical study evaluating Hydrocortisone and Normal Saline for Heart Disease Congenital Complex. Completed, enrolled 40 participants across 1 site.

Detailed Summary

This protocol is designed to offer insight into critical illness related corticosteroid insufficiency and steroid supplementation in neonates undergoing cardiac surgery with cardiopulmonary bypass by administering exogenous steroids in the immediate post-operative period.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHeart Disease Congenital Complex
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedMay 10, 2012
Enrollment StartApr 1, 2012
Primary CompletionNov 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 14.1 years ago

Interventions

Hydrocortisonedrug

The drug will be bolused at 50mg/m2 followed by a continuous infusion that will start at 50mg/m2 for the first 48 hours and then be tapered as follows: 40mg/m2/day over 24 hours, 30mg/m2/day over 12 hours, 20 mg/m2/day over 12 hours, 10mg/m2/day over 24 hours, then off.

Normal Salinedrug

This will be bolused and infused in the same manner as the hydrocortisone arm to ensure blinding of study arm.