Clinical trial NCT04259684: Nitric Oxide During Cardiopulmonary Bypass in Neonates to Reduce Risk of Acute Kidney Injury
Official title: Efficacy of Nitric Oxide Administration During Cardiopulmonary Bypass in Neonates at Reducing the Risk of Acute Kidney Injury: a Preliminary Double-blind Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
PHASE3
Conditions: Acute Kidney Injury
Congenital Heart Disease
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
First posted: 2020-02-06
Enrollment: 0
Sex: ALL
Maximum age (years): 31
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Each of the 40 participants will be stratified based on type of lesion (single ventricle vs. biventricular lesions) and block randomized into 1 of 2 study arms: treatment arm (receiving intraoperative administration of 20 ppm of gNO to the oxygenator of the CPB circuit) and control arm (standard CPB conduct).
Primary purpose: PREVENTION

Brief summary: Acute kidney injury following cardiac surgery for congenital heart defects in children is a major cause of both short- and long-term morbidity and mortality, affecting up to 60% of high risk patients. Despite effort, to date, no successful therapeutic agent has gained widespread success in preventing this postoperative decline in renal function. Based on preliminary data available in the literature, we hypothesize that nitric oxide (gNO), administered during cardiopulmonary bypass (CPB), may reduce the risk of acute kidney injury (AKI) via mechanisms of reduced inflammation and vasodilation. In this pilot study, 40 neonates undergoing cardiac surgery will be randomized to receive intraoperative administration of 20 ppm of nitric oxide to the oxygenator of the cardiopulmonary bypass circuit or standard CPB with no additional gas.


Eligibility criteria: Inclusion Criteria:

* Neonates (≤31 days) undergoing cardiac surgery with cardiopulmonary bypass for congenital heart disease

Exclusion Criteria:

* 1. 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 \<2.2 kg,
* Gestational age \<36 weeks,
* Major extracardiac congenital anomalies.

Primary outcomes:
measure: Acute Kidney Injury
timeFrame: up to 72 hours postoperative
measure: Glomerular Filtration Rate
timeFrame: up to 72 hours postoperative
Secondary outcomes:
measure: Structural Kidney Injury
timeFrame: up to 72 hours postoperative
measure: Low cardiac output syndrome (LCOS)
timeFrame: up to 48 hours postoperative
measure: Duration of mechanical ventilation
timeFrame: up to 2 weeks from admission to CICU to extubation
measure: Length of cardiac intensive care unit (CICU) stay
timeFrame: up to 2 weeksfrom admission to CICU to discharge from CICU
measure: Length of hospital stay
timeFrame: up to 30 days from hospital admission to discharge
measure: Inotrope free days
timeFrame: up to 30 days after surgery to CICU discharge
measure: ECMO free days
timeFrame: up to 2 weeks after surgery to CICU discharge
measure: Closed sternum days
timeFrame: up to 2 weeks from postoperative CICU admission to discharge
measure: Time to negative fluid balance
timeFrame: up to 2 weeks from CICU admission to outcome reached
measure: Urine Output
timeFrame: up to two weeks from CICU admission to discharge
measure: Use of peritoneal dialysis
timeFrame: up to two weeks from CICU admission to discharge
measure: Cardiac arrest
timeFrame: up to two weeks from CICU admission to discharge
measure: Use of postoperative inhaled Nitric Oxide (iNO)
timeFrame: up to two weeks from CICU admission to discharge
Other outcomes:
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