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NO During CPB in Neonates to Reduce Risk of AKI

RecruitingPhase 3Ages 1 Day - 31 DaysAllChildren's Hospital Medical Center, Cincinnati
NCT04216927 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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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📋 Eligibility rules (as published)
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.
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What it tests

  • Nitric Oxide
  • Oxygen
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Where

1 site
Cincinnati Children's Hospital Medical Center
Cincinnati, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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