NO During CPB in Neonates to Reduce Risk of AKI

Part of paid clinical trials in Cincinnati, Ohio.

Sponsor
Children's Hospital Medical Center, Cincinnati
Study ID
NCT04216927
Phase
PHASE3
Status
Recruiting
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Conditions

  • AKI
  • CHD - Congenital Heart Disease
  • Surgery

Eligibility Criteria

Sex
ALL
Age
1 Day - 31 Days
Healthy Volunteers
Not accepted

Interventions

  • Nitric Oxide — DRUG
    gNO will be entrained at 20 ppm into the oxygenator of the CPB circuit
  • Oxygen — DRUG
    Oxygen alone will be entrained for placebo arm

Study Details

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.

Key Dates

Start date
Jan 10, 2023
Status verified
Jul 2025
Primary completion
Jun 30, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION

Arms

  • Experimental: Nitric Oxide
    Intraoperative NO entrained at 20 ppm into the oxygenator of the CPB circuit with standard care
  • Placebo Comparator: Oxygen
    Standard CPB without NO administered at any point intraoperatively

Primary Outcome Measure

AKI [ Time Frame: 72 hours ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Cincinnati Children's Hospital Medical CenterCincinnatiOhio45229
David S. Cooper, MD
[email protected]
5138035448

Find similar trials in Cincinnati, OH

By research site
Cincinnati Children's Hospital Medical Center· Cincinnati, OH

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