CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 18 enrolled
Drug / intervention
Hydrocortisone +1 moredrug
Likely dose
Hydrocortisone 100mg/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/NCT00590018
NCT00590018Phase 2Completed

Corticosteroids in Postoperative Critically Ill Neonates With Low Cardiac Output Syndrome With Congenital Heart Disease

Baylor College of Medicine·interventional·Posted Jan 10, 2008·Updated May 26, 2016

In Brief

A Phase 2 clinical trial evaluating Hydrocortisone and Placebo for Cardiac Output, Low. Completed, enrolled 18 participants across 1 site.

Detailed Summary

Babies having heart surgery often have problems after surgery with their blood pressure and getting enough blood to their bodies. To treat this they require medicines to keep their blood pressure high enough to get blood to their bodies. The side effects of these medicines include fast heart rates and increasing the amount of work the heart has to do. Corticosteroids are made by the body and help to use the energy in the food people eat, control the chemicals in their blood and maintain their blood pressure. Corticosteroids made by the body may be decreased in patients that have major surgery. Corticosteroids help to increase blood pressure and can decrease the amount of blood pressure medicines a patient requires. Corticosteroids have been shown to increase blood pressure in patients with bacterial infections and in very small, premature babies but have only been studied in a few babies who have had heart surgery. The way corticosteroids work is unknown but may involve decreasing the body's response to being on a heart-lung machine or give steroids not being made by the patient. Corticosteroids have been shown to be helpful in treating many diseases. The purpose of this study is to look at the effects of corticosteroids in babies who have had heart surgery and need blood pressure medicines in the intensive care unit after surgery. Our idea is that getting corticosteroids will allow us to decrease the amount of blood pressure medicines each patient needs and improve how they do after surgery. We also plan to do blood tests to help determine how the corticosteroids are working. It will be randomly determined if the subject receives corticosteroids or salt water. The subject will receive a corticosteroid or salt water once a day for five days. Their vital signs will be monitored, especially blood pressure and their need for medicines to increase their blood pressure. Blood work will also be obtained to determine their body's ability to make steroids.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 10, 2008
Enrollment StartFeb 1, 2003
Primary CompletionDec 1, 2009
TodayJul 2, 2026
Enrollment to primary: 6.8 yearsPosted 18.5 years ago

Interventions

Hydrocortisonedrug

Hydrocortisone taper (100mg/m2/day --\> 25mg/m2/day) over 5 days intravenously.

Placebodrug

Placebo for 5 days intravenously.