NO During CPB in Neonates to Reduce Risk of AKI

Launched by CHILDREN'S HOSPITAL MEDICAL CENTER, CINCINNATI · Dec 31, 2019

Keywords

ClinConnect Summary

This clinical trial is studying whether giving nitric oxide during heart surgery can help reduce the risk of acute kidney injury (AKI) in newborns with congenital heart defects. AKI can be a serious complication that affects many children after surgery, leading to health problems both in the short and long term. Researchers believe that nitric oxide, which helps improve blood flow and manage inflammation, might protect the kidneys during surgery.

To participate in this study, babies up to 31 days old who are scheduled for heart surgery that requires a heart-lung machine (known as cardiopulmonary bypass) may be eligible. However, certain conditions may disqualify them, such as having a pre-existing kidney problem or being too small. Families who agree to participate will help researchers understand if nitric oxide can make a difference in kidney health after surgery. This trial is currently recruiting participants, and it aims to find a new way to keep our youngest patients safer during important heart procedures.

Gender

ALL

Eligibility criteria

• 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.