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NO During CPB in Neonates to Reduce Risk of AKI

NCT04216927 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-07-24

No results posted yet for this 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

  • AKI
  • CHD - Congenital Heart Disease
  • Surgery

Interventions

DRUG

Nitric Oxide

gNO will be entrained at 20 ppm into the oxygenator of the CPB circuit

DRUG

Oxygen

Oxygen alone will be entrained for placebo arm

Sponsors & Collaborators

  • Mallinckrodt

    collaborator INDUSTRY

  • Indiana University

    collaborator OTHER

  • Children's Hospital Medical Center, Cincinnati

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
SEQUENTIAL

Eligibility

Min Age
1 Day
Max Age
31 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-10
Primary Completion
2026-06-30
Completion
2026-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04216927 on ClinicalTrials.gov