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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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04216927
The ClinicalTrials.gov registry entry for NCT04216927 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 52,851-participant average among 120 other Surgery trials with a reported enrollment target (100% lower). The listed sponsor is Children's Hospital Medical Center, Cincinnati, which has 571 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.