NO During CPB in Neonates to Reduce Risk of AKI
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Nitric Oxide, Oxygen.
- Who it may be relevant to
- Registry conditions: AKI, CHD - Congenital Heart Disease, Surgery. Basic parameters: 1 Day — 31 Days · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Efficacy of Nitric Oxide Administration During Cardiopulmonary Bypass in Neonates at Reducing the Risk of Acute Kidney Injury
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.
Interventions
- Drug Nitric Oxide
gNO will be entrained at 20 ppm into the oxygenator of the CPB circuit - Drug Oxygen
Oxygen alone will be entrained for placebo arm
Primary outcome measures
- AKI [Time frame: 72 hours]
Secondary outcome measures (7)
- Biomarker evidence of AKI - NGAL [Time frame: 72 hours]
- Biomarker evidence of AKI - KIM-1 [Time frame: 72 hours]
- Biomarker evidence of AKI - IL-18 [Time frame: 72 hours]
- Biomarker evidence of AKI - L-FABP [Time frame: 72 hours]
- Biomarker evidence of AKI - urinary nitrite [Time frame: 72 hours]
- Impact on GFR [Time frame: 72 hours]
- Low Cardiac Output [Time frame: 48 hours]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Sequential
- Masking
- Triple blind
- Primary purpose
- Prevention
Study locations
United States · 1 center
- Cincinnati Children's Hospital Medical Center — Cincinnati
Identifiers
NCT: NCT04216927 · MOD00004808