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NCT02956707 · ClinicalTrials.gov registry record
Impact of Pre-operative Steroids on Adrenal Insufficiency
A clinical trial, sponsored by University of Alabama at Birmingham.
- Completed
- Registry status
- 50
- Enrollment target
NCT02956707 is a clinical trial that has completed, run by University of Alabama at Birmingham. The registered enrollment target is 50 participants.
The verdict
NCT02956707 has completed, sponsored by University of Alabama at Birmingham.
- COMPLETED
- Registry status
- 50 participants
- Enrollment target
Study Summary
Little is known regarding the incidence and clinical impact of AI in neonates during the acute postoperative period following separation from CPB. In a randomized control pilot study performed by the UAB CVICU research team, prophylactic post-CPB hydrocortisone infusions improved some postoperative outcomes, especially in those that acquired AI7. In an attempt to further explore post-CPB AI, a retrospective analysis of data from this study was performed. Of the 40 neonates included in the study, one-third (32.5%) developed AI following CPB (as determined by low-dose, 1 µg, cosyntropin stimulation test). Almost all of these subjects had normal response to cosyntropin stimulation pre-CPB. Subjects that developed AI demonstrated more hemodynamic instability, increased serum lactate and required more colloid resuscitation in the immediate post-CPB period in the operating room. Recent evidence has begun to highlight potential morbidity associated with perioperative steroid administration. Our cardiac surgery program is changing clinical practice and ceasing to give preoperative steroids to all patients (previously only neonatal CPB patients received preoperative methylprednisolone). With the possibility that preoperative steroid administration, and not CPB, primarily causes the high incidence of AI, it is prudent to further investigate the benefit and/or harm of perioperative steroid administration
Interventions
- OTHER No pre-operative steroids
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2016-07 |
| Est. Completion | 2019-01-12 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02956707
The ClinicalTrials.gov registry entry for NCT02956707 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Alabama at Birmingham, which has 1,160 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which No pre-operative steroids is the first listed.
NCT02956707 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02956707 about?
NCT02956707 is a clinical study titled "Impact of Pre-operative Steroids on Adrenal Insufficiency". Little is known regarding the incidence and clinical impact of AI in neonates during the acute postoperative period following separation from CPB. In a randomized control pilot study performed by the UAB CVICU research team, prophylactic post-CPB hydrocortisone infusions improved some postoperative ...
What is the current status of trial NCT02956707?
This trial is currently completed. The enrollment target is 50 participants. The study started on 2016-07. Estimated completion is 2019-01-12.
What interventions are being tested in trial NCT02956707?
The interventions under investigation include: No pre-operative steroids (OTHER).
Who is sponsoring clinical trial NCT02956707?
This trial is sponsored by University of Alabama at Birmingham, which has 1,160 total clinical trials registered on ClinicalTrials.gov.
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