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NCT04216927 · ClinicalTrials.gov registry record · Phase 3
NO During CPB in Neonates to Reduce Risk of AKI
A Phase 3 study of Surgery and AKI, sponsored by Children's Hospital Medical Center, Cincinnati.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 40
- Enrollment target
- 1
- Study location
NCT04216927: Recruiting Phase 3 study of Surgery and AKI, sponsored by Children's Hospital Medical Center, Cincinnati.
NCT04216927 is a Phase 3 study of Surgery and AKI that is actively recruiting participants, run by Children's Hospital Medical Center, Cincinnati. The registered enrollment target is 40 participants, below the 52,851-participant average among 120 other Surgery trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04216927, a Phase 3 study of Surgery and AKI, is actively recruiting participants, sponsored by Children's Hospital Medical Center, Cincinnati.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 40 participants
- Enrollment target
- 1
- Study location
Study Summary
Acute kidney injury (AKI) following cardiac surgery for congenital heart defects (CHD) in children affects up to 60% of high risk-patients and is a major cause of both short- and long-term morbidity and mortality. Despite effort, to date, no successful therapeutic agent has gained widespread success in preventing this postoperative decline in renal function. Nitric oxide is an intricate regulator of acute inflammation and coagulation and is a potent vasodilator. The investigators hypothesize that nitric oxide, administered during cardiopulmonary bypass (CPB), may reduce the incidence of AKI.
Primary Outcome
Incidence of AKI in the first 72 hours postoperative as defined by the Kidney Disease Improving Global Outcomes (KDIGO) diagnostic classification
Conditions Studied
Interventions
- DRUG Nitric Oxide
- DRUG Oxygen
Study Locations (1)
Ohio
- Cincinnati Children's Hospital Medical Center - Cincinnati
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2023-01-10 |
| Est. Completion | 2026-06-30 |
| Phase | Phase 3 |
What NCT04216927 shows while recruiting
NCT04216927 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 52,851-participant average among 120 other Surgery trials with a reported enrollment target (100% lower).
The record links to 3 conditions, with Surgery appearing as the primary indexed condition, and to 2 interventions - of which Nitric Oxide is the first listed.
NCT04216927 reports a single indexed study location in Ohio.
Frequently Asked Questions
What is clinical trial NCT04216927 about?
NCT04216927 is a clinical study titled "NO During CPB in Neonates to Reduce Risk of AKI". Acute kidney injury (AKI) following cardiac surgery for congenital heart defects (CHD) in children affects up to 60% of high risk-patients and is a major cause of both short- and long-term morbidity and mortality. Despite effort, to date, no successful therapeutic agent has gained widespread success...
What is the current status of trial NCT04216927?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 40 participants. The study started on 2023-01-10. Estimated completion is 2026-06-30.
What conditions does trial NCT04216927 study?
This clinical trial studies the following conditions: Surgery, AKI, CHD - Congenital Heart Disease.
What interventions are being tested in trial NCT04216927?
The interventions under investigation include: Nitric Oxide (DRUG), Oxygen (DRUG).
Who is sponsoring clinical trial NCT04216927?
This trial is sponsored by Children's Hospital Medical Center, Cincinnati, which has 571 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04216927 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Surgery
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 NCT04216927's enrollment target sits among peer trials
40 100th of 120 higher than 19 of 120 other Surgery trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Surgery 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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