NO During CPB in Neonates to Reduce Risk of AKI

Description

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

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Study Overview

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Study Details

Study overview

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.

Efficacy of Nitric Oxide Administration During Cardiopulmonary Bypass in Neonates at Reducing the Risk of Acute Kidney Injury

NO During CPB in Neonates to Reduce Risk of AKI

Condition
AKI
Intervention / Treatment

-

Contacts and Locations

Cincinnati

Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, United States, 45229

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

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

Ages Eligible for Study

1 Day to 31 Days

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Children's Hospital Medical Center, Cincinnati,

Study Record Dates

2025-06-01