Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed Phase 1 study of Infant Morbidity and Adrenal Cortex Diseases, sponsored by Mayo Clinic.
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, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (42% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Primary outcome measure is the cortisol level for each patient at 7 time points throughout the operation and first 24 post-operative hours. Dexamethasone level of the patient is compared with the cortisol level.
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 |
What the finished NCT01839812 record still lists
NCT01839812 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 35 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (42% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Infant Morbidity
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01839812's enrollment target sits among peer trials
35 1258th of 2000 higher than 728 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT01697371 · 35 participants · NA
Proton Therapy in the Treatment of Liver Metastases
- NCT01940757 · 35 participants · Phase 1
Experimental Infection of Hookworm-naïve Adults With Dermally-applied Infectious Necator Americanus Hookworm Larvae
- NCT02235857 · 35 participants · NA
Post Approval Study of Liposorber LA-15 System for the Treatment of Focal Segmental Glomerulosclerosis in Children
- NCT02637934 · 35 participants · Phase 1
Phase I Pilot Study of Biodistribution, Metabolism and Excretion of Novel Radiotracer [18F]Fluorthanatrace (FTT) by PET/CT
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia