NO During CPB in Neonates to Reduce Risk of AKI

Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04216927
• Other study ID #: MOD00004808
• Status: Recruiting
• Phase: Phase 3
• Start date: January 10, 2023
• Est. completion date: June 1, 2025

Study information

• Verified date: March 2024
• Source: Children's Hospital Medical Center, Cincinnati
• Contact: David S Cooepr, MD
• Phone: 5138035448
• Email: David.Cooper[@]cchmc.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: June 1, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Day to 31 Days

Eligibility

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.

Related Conditions & MeSH terms

• AKI
• CHD - Congenital Heart Disease
• Heart Defects, Congenital
• Heart Diseases
• Surgery

Intervention

Drug:
• Nitric Oxide
gNO will be entrained at 20 ppm into the oxygenator of the CPB circuit
• Oxygen
Oxygen alone will be entrained for placebo arm

Locations

Country	Name	City	State
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio

Sponsors (3)

Lead Sponsor	Collaborator
Children's Hospital Medical Center, Cincinnati	Indiana University, Mallinckrodt

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AKI	Incidence of AKI in the first 72 hours postoperative as defined by the Kidney Disease Improving Global Outcomes (KDIGO) diagnostic classification	72 hours
Secondary	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)	72 hours
Secondary	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)	72 hours
Secondary	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)	72 hours
Secondary	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)	72 hours
Secondary	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.	72 hours
Secondary	Impact on GFR	Postoperative GFR measured using serum cystatin C.	72 hours
Secondary	Low Cardiac Output	Incidence of low cardiac output syndrome (LCOS) during the first 48 hours postoperative	48 hours