NO During CPB in Neonates to Reduce Risk of AKI

Phase 3RecruitingNCT04216927

Children's Hospital Medical Center, Cincinnati40 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

Conditions

AKI CHD - Congenital Heart Disease Surgery

Interventions

Eligibility

Sex: ALLMin age: 1 DayMax age: 31 Days

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

AKI

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

Time frame: 72 hours

Secondary Outcomes

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)

Time frame: 72 hours

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)

Time frame: 72 hours

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)

Time frame: 72 hours

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)

Time frame: 72 hours

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.

Time frame: 72 hours

Impact on GFR

Postoperative GFR measured using serum cystatin C.

Time frame: 72 hours

Low Cardiac Output

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

Time frame: 48 hours

NO During CPB in Neonates to Reduce Risk of AKI

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts