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NCT00590018 · ClinicalTrials.gov registry record · Phase 2
Corticosteroids in Postoperative Critically Ill Neonates With Low Cardiac Output Syndrome With Congenital Heart Disease
A Phase 2 study of Cardiac Output, Low, sponsored by Baylor College of Medicine.
- Completed
- Registry status
- Phase 2
- Development phase
- 18
- Enrollment target
- 1
- Study location
NCT00590018: Completed Phase 2 study of Cardiac Output, Low, sponsored by Baylor College of Medicine.
NCT00590018 is a Phase 2 study of Cardiac Output, Low that has completed, run by Baylor College of Medicine. The registered enrollment target is 18 participants, below the 135-participant average among 4 other Cardiac Output, Low trials with a reported enrollment target (87% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00590018, a Phase 2 study of Cardiac Output, Low, has completed, sponsored by Baylor College of Medicine.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 18 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Change in mean blood pressure recorded prior to (15 minutes prior to study drug) and subsequent to medication/placebo administration (at 2 days post drug administration).
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Hydrocortisone
Study Locations (1)
Texas
- Texas Children's Hospital - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2003-02 |
| Est. Completion | 2009-12 |
| Phase | Phase 2 |
What the finished NCT00590018 record still lists
NCT00590018 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 135-participant average among 4 other Cardiac Output, Low trials with a reported enrollment target (87% lower).
The record links to 1 condition, with Cardiac Output, Low appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT00590018 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT00590018 about?
NCT00590018 is a clinical study titled "Corticosteroids in Postoperative Critically Ill Neonates With Low Cardiac Output Syndrome With Congenital Heart Disease". 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 a...
What is the current status of trial NCT00590018?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 18 participants. The study started on 2003-02. Estimated completion is 2009-12.
What conditions does trial NCT00590018 study?
This clinical trial studies the following conditions: Cardiac Output, Low.
What interventions are being tested in trial NCT00590018?
The interventions under investigation include: Placebo (DRUG), Hydrocortisone (DRUG).
Who is sponsoring clinical trial NCT00590018?
This trial is sponsored by Baylor College of Medicine, which has 616 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00590018 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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