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NCT01579513 · ClinicalTrials.gov registry record · NA
Corticosteroid Therapy in Neonates Undergoing Cardiopulmonary Bypass
A NA study, sponsored by Medical University of South Carolina.
- Completed
- Registry status
- NA
- Development phase
- 190
- Enrollment target
NCT01579513: Completed NA study, sponsored by Medical University of South Carolina.
NCT01579513 is a NA study that has completed, run by Medical University of South Carolina. The registered enrollment target is 190 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (86% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01579513, a NA study, has completed, sponsored by Medical University of South Carolina.
- COMPLETED
- Registry status
- NA
- Development phase
- 190 participants
- Enrollment target
Study Summary
Although cardiopulmonary bypass (heart-lung machine) is a necessary component of heart surgery, it is not without consequences. Cardiopulmonary bypass initiates a potent inflammatory response secondary to the body's recognition of the abnormal environment of the heart-lung machine. This inflammatory response may lead to poor heart, lung and kidney function after the heart surgery. This is turn can lead to longer times on the ventilator (breathing machine), the need for higher doses of heart medications, a longer stay in the intensive care unit and even death. This is particularly true in infants less than one month of age due to their size and the immaturity of their organs. The appreciation of the post-cardiopulmonary bypass inflammatory response has resulted in a number of interventions directed at its reduction. No therapy has been recognized as the standard of care; however steroid therapy has been applied most often despite unclear evidence of a benefit. This study aims to determine if steroids improve the outcomes of babies undergoing heart surgery.
Primary Outcome
The composite morbidity-mortality outcome will be met if any of the following occur after surgery but before hospital discharge: death, cardiac arrest, extracorporeal membrane oxygenation, renal insufficiency (creatinine more than two times normal), hepatic insufficiency (aspartate aminotransferase or alanine aminotransferase more than two times normal), or rising lactic acidosis (\>5mmol/L). This outcome was choosen because death rarely occurs in this population. We have found this endpoint to
Interventions
- DRUG Placebo
- DRUG Methylprednisolone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 190 participants |
| Start Date | 2012-06 |
| Est. Completion | 2018-12-19 |
| Phase | NA |
What the finished NCT01579513 record still lists
NCT01579513 is an interventional study that assigns participants to a tested intervention. The registered 190 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (86% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01579513 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01579513 about?
NCT01579513 is a clinical study titled "Corticosteroid Therapy in Neonates Undergoing Cardiopulmonary Bypass". Although cardiopulmonary bypass (heart-lung machine) is a necessary component of heart surgery, it is not without consequences. Cardiopulmonary bypass initiates a potent inflammatory response secondary to the body's recognition of the abnormal environment of the heart-lung machine. This inflammatory...
What is the current status of trial NCT01579513?
This trial is currently completed. It is a NA study. The enrollment target is 190 participants. The study started on 2012-06. Estimated completion is 2018-12-19.
What interventions are being tested in trial NCT01579513?
The interventions under investigation include: Placebo (DRUG), Methylprednisolone (DRUG).
Who is sponsoring clinical trial NCT01579513?
This trial is sponsored by Medical University of South Carolina, which has 755 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01579513's enrollment target sits among peer trials
190 574th of 2000 higher than 1,425 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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