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Corticosteroids in Postoperative Critically Ill Neonates With Low Cardiac Output Syndrome With Congenital Heart Disease
NCT00590018 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00590018
The ClinicalTrials.gov registry entry for NCT00590018 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 18 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Baylor College of Medicine, which has 678 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00590018 reports 1 study location spanning 1 distinct geographic area — top geographies include Texas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00590018?
The interventions under investigation include: Placebo (DRUG), Hydrocortisone (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00590018?
This trial is sponsored by Baylor College of Medicine, which has 678 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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