NO During CPB in Neonates to Reduce Risk of AKI

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-10

Study Completion Date

2026-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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AKI CHD - Congenital Heart Disease Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

• This pilot study is a single center, double-blind, randomized controlled trial.

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Nitric Oxide

Intraoperative NO entrained at 20 ppm into the oxygenator of the CPB circuit with standard care

Group Type EXPERIMENTAL

Nitric Oxide

Intervention Type DRUG

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

Oxygen

Standard CPB without NO administered at any point intraoperatively

Group Type PLACEBO_COMPARATOR

Oxygen

Intervention Type DRUG

Oxygen alone will be entrained for placebo arm

Interventions

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Nitric Oxide

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

Intervention Type DRUG

Oxygen

Oxygen alone will be entrained for placebo arm

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* All neonates (≤31 days) undergoing cardiac surgery with CPB for CHD will be deemed eligible for enrollment.

Exclusion Criteria

1. Failure to obtain informed consent from parent/guardian
2. Clinical signs of preoperative persistent elevated pulmonary vascular resistance,
3. Emergency surgery,
4. Episode of cardiac arrest within 1 week before surgery,
5. Recent treatment with steroids and/or a condition that may require treatment with steroids (excluding steroid administration specifically for CPB),
6. Use of inhaled NO (iNO) immediately prior to surgery,
7. Structural renal abnormalities by ultrasound,
8. Preoperative AKI,
9. Use of other investigational drugs,
10. Weight less than \<2 kg,
11. Gestational age \<36 weeks,
12. Major extracardiac congenital anomalies,
13. Non-English speakers.

Minimum Eligible Age

1 Day

Maximum Eligible Age

31 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No