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NCT01915277 · ClinicalTrials.gov registry record · Phase 1
A Phase I Study of Dexmedetomidine Bolus and Infusion in Corrective Infant Cardiac Surgery: Safety and Pharmacokinetics
A Phase 1 study, sponsored by Carelon Research.
- Completed
- Registry status
- Phase 1
- Development phase
- 119
- Enrollment target
NCT01915277: Completed Phase 1 study, sponsored by Carelon Research.
NCT01915277 is a Phase 1 study that has completed, run by Carelon Research. The registered enrollment target is 119 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (98% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01915277, a Phase 1 study, has completed, sponsored by Carelon Research.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 119 participants
- Enrollment target
Study Summary
The purpose of this Phase I study is to determine the safety of a drug called dexmedetomidine (DEX) as part of a balanced general anesthetic and sedative strategy for neonates and infants undergoing corrective cardiac surgery that requires the use of cardiopulmonary bypass for congenital cardiac problems. This study will also design and validate a dosing schema for the use of DEX as described above.
Primary Outcome
The occurrence of any of the following that is possibly, probably, or definitely related to DEX administration: * Bradycardia * Heart block * Junctional rhythm * Hypotension * Excessive sedation * Cardiac arrest or ECMO cannulation * Serious Adverse Event (SAE) Both the DEX dose, and DEX exposure will be assessed for associations with the primary outcome.
Interventions
- DRUG Dexmedetomidine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 119 participants |
| Start Date | 2014-04-02 |
| Est. Completion | 2017-10-17 |
| Phase | Phase 1 |
What the finished NCT01915277 record still lists
NCT01915277 is an interventional study that assigns participants to a tested intervention. The registered 119 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (98% higher).
The record links to 0 conditions, and to 1 intervention - of which Dexmedetomidine is the first listed.
NCT01915277 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01915277 about?
NCT01915277 is a clinical study titled "A Phase I Study of Dexmedetomidine Bolus and Infusion in Corrective Infant Cardiac Surgery: Safety and Pharmacokinetics". The purpose of this Phase I study is to determine the safety of a drug called dexmedetomidine (DEX) as part of a balanced general anesthetic and sedative strategy for neonates and infants undergoing corrective cardiac surgery that requires the use of cardiopulmonary bypass for congenital cardiac pro...
What is the current status of trial NCT01915277?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 119 participants. The study started on 2014-04-02. Estimated completion is 2017-10-17.
What interventions are being tested in trial NCT01915277?
The interventions under investigation include: Dexmedetomidine (DRUG).
Who is sponsoring clinical trial NCT01915277?
This trial is sponsored by Carelon Research, which has 50 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01915277's enrollment target sits among peer trials
119 498th of 2000 higher than 1,502 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
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