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NCT Number: NCT04216927

NO During CPB in Neonates to Reduce Risk of AKI

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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Key information

Conditions

AKI CHD - Congenital Heart Disease Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases Surgery

Age range

1 day–31 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location status: Recruiting

Location contact

David S. Cooper, MD

CONTACT

[email protected]

5138035448

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

nitric oxide

Drug

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

Oxygen

Drug

Oxygen alone will be entrained for placebo arm

Primary outcomes

  1. AKI

    Time frame: 72 hours

    Incidence of AKI in the first 72 hours postoperative as defined by the Kidney Disease Improving Global Outcomes (KDIGO) diagnostic classification

Secondary outcomes

  1. Biomarker evidence of AKI - NGAL

    Time frame: 72 hours

    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

    Time frame: 72 hours

    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

    Time frame: 72 hours

    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

    Time frame: 72 hours

    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

    Time frame: 72 hours

    Incidence of structural AKI in the first 72 hours postoperative will be assessed by measurement of urine biomarker urinary nitrate.

  6. Impact on GFR

    Time frame: 72 hours

    Postoperative GFR measured using serum cystatin C.

  7. Low Cardiac Output

    Time frame: 48 hours

    Incidence of low cardiac output syndrome (LCOS) during the first 48 hours postoperative

Study contacts

Contact information is provided by the study sponsor or research team.

David S Cooepr, MD

CONTACT

[email protected]

5138035448

Sponsors and collaborators

Lead sponsor

Children's Hospital Medical Center, Cincinnati

Other

Collaborators

  • Indiana University
  • Mallinckrodt

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jan 3, 2020
Registry last updated
Jul 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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