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NCT01839812 · ClinicalTrials.gov registry record · Phase 1
Adrenal Responsiveness During the Perioperative Period in Children Undergoing Congenital Cardiac Surgery
A Phase 1 study of Infant Morbidity and Adrenal Cortex Diseases, sponsored by Mayo Clinic.
- Completed
- Registry status
- Phase 1
- Development phase
- 35
- Enrollment target
- 1
- Study location
NCT01839812 is a Phase 1 study of Infant Morbidity and Adrenal Cortex Diseases that has completed, run by Mayo Clinic. The registered enrollment target is 35 participants. The trial reports 1 study location across 1 state.
The verdict
NCT01839812, a Phase 1 study of Infant Morbidity and Adrenal Cortex Diseases, has completed, sponsored by Mayo Clinic.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 35 participants
- Enrollment target
- 1
- Study location
Study Summary
Our objective was to determine whether a standard 1mg/kg intraoperative dose of dexamethasone results in similar drug levels for all patients and to characterize the relationship between these drug levels and the innate stress response following infant Cardiopulmonary Bypass (CPB). The investigators hypothesized that postoperative dexamethasone levels are highly variable, and that the infant stress response is inversely related to the amount of dexamethasone measured in the blood. To test this theory the investigators simultaneously measured blood levels of dexamethasone and cortisol at critical time points during the perioperative period for infants undergoing CPB for CHD surgery.
Conditions Studied
Interventions
- DRUG Cosyntropin
Study Locations (1)
Minnesota
- Mayo Clinic - Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2009-03 |
| Est. Completion | 2013-06 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01839812
The ClinicalTrials.gov registry entry for NCT01839812 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 35 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Mayo Clinic, which has 2,844 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Infant Morbidity appearing as the primary indexed condition, and to 1 intervention - of which Cosyntropin is the first listed.
NCT01839812 reports 1 study location spanning 1 distinct geographic area - top geographies include Minnesota.
Frequently Asked Questions
What is clinical trial NCT01839812 about?
NCT01839812 is a clinical study titled "Adrenal Responsiveness During the Perioperative Period in Children Undergoing Congenital Cardiac Surgery". Our objective was to determine whether a standard 1mg/kg intraoperative dose of dexamethasone results in similar drug levels for all patients and to characterize the relationship between these drug levels and the innate stress response following infant Cardiopulmonary Bypass (CPB). The investigators...
What is the current status of trial NCT01839812?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 35 participants. The study started on 2009-03. Estimated completion is 2013-06.
What conditions does trial NCT01839812 study?
This clinical trial studies the following conditions: Infant Morbidity, Adrenal Cortex Diseases.
What interventions are being tested in trial NCT01839812?
The interventions under investigation include: Cosyntropin (DRUG).
Who is sponsoring clinical trial NCT01839812?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01839812 being conducted?
This trial has 1 study location across Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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