NO During CPB in Neonates to Reduce Risk of AKI

Recruitment Status
RECRUITING
(See Contacts and Locations)Verified June 2025 by Children's Hospital Medical Center, Cincinnati
Sponsor
Children's Hospital Medical Center, Cincinnati
Information Provided by (Responsible Party)
Children's Hospital Medical Center, Cincinnati
Clinicaltrials.gov Identifier
NCT04216927
Other Study ID Numbers:
MOD00004808
First Submitted
December 3, 2019
First Posted
January 2, 2020
Last Update Posted
July 23, 2025
Last Verified
June 2025

ClinicalTrials.gov processed this data on July 2025. Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study Description

Condition or DiseaseIntervention/Treatment
AKICHD - Congenital Heart DiseaseSurgery
Drug: Nitric OxideDrug: Oxygen

Study Design

Study TypeInterventional
Actual Enrollment40 participants
Design AllocationRandomized
Interventional ModelSequential Assignment
MaskingTriple
Primary PurposePrevention
Official TitleEfficacy of Nitric Oxide Administration During Cardiopulmonary Bypass in Neonates at Reducing the Risk of Acute Kidney Injury
Study Start DateJanuary 9, 2023
Actual Primary Completion Date1mo 3d from now
Actual Study Completion Date1mo 3d from now

Groups and Cohorts

Group/CohortIntervention/Treatment
Nitric Oxide
Intraoperative NO entrained at 20 ppm into the oxygenator of the CPB circuit with standard care
Drug: Nitric Oxide
gNO will be entrained at 20 ppm into the oxygenator of the CPB circuit
Oxygen
Standard CPB without NO administered at any point intraoperatively
Drug: Oxygen
Oxygen alone will be entrained for placebo arm

Outcome Measures

Primary Outcome Measures
  1. AKI
    Incidence of AKI in the first 72 hours postoperative as defined by the Kidney Disease Improving Global Outcomes (KDIGO) diagnostic classification
Secondary Outcome Measures
  1. Biomarker evidence of AKI - NGAL
    Incidence of structural AKI in the first 72 hours postoperative will be assessed by measurement of urine biomarker neutrophil gelatinase-associated lipocalin (NGAL)
  2. Biomarker evidence of AKI - KIM-1
    Incidence of structural AKI in the first 72 hours postoperative will be assessed by measurement of urine biomarker kidney injury molecule-1 (KIM-1)
  3. Biomarker evidence of AKI - IL-18
    Incidence of structural AKI in the first 72 hours postoperative will be assessed by measurement of urine biomarker interleukin-18 (IL-18)
  4. Biomarker evidence of AKI - L-FABP
    Incidence of structural AKI in the first 72 hours postoperative will be assessed by measurement of urine biomarker liver-type fatty acid-binding protein (L-FABP)
  5. Biomarker evidence of AKI - urinary nitrite
    Incidence of structural AKI in the first 72 hours postoperative will be assessed by measurement of urine biomarker urinary nitrate.
  6. Impact on GFR
    Postoperative GFR measured using serum cystatin C.
  7. Low Cardiac Output
    Incidence of low cardiac output syndrome (LCOS) during the first 48 hours postoperative

Eligibility Criteria

Ages Eligible for Study(Child)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
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.

Contacts and Locations

Sponsors and CollaboratorsChildren's Hospital Medical Center, Cincinnati
Locations
Cincinnati Children's Hospital Medical Center | Cincinnati Ohio, United States, 45229