Nitric Oxide During CPB to Reduce AKI in Neonates

Acute Kidney Injury Clinical Trial

Official title:

A Prospective Randomized Controlled Trial of Supplemental Nitric Oxide During Cardiopulmonary Bypass to Reduce Acute Kidney Injury After Cardiac Surgery

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03946462
• Other study ID #: H-44435
• Status: Withdrawn
• Phase: Phase 1
• Start date: October 2021
• Est. completion date: March 2023

Study information

• Verified date: November 2021
• Source: Baylor College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a prospective, randomized, double-blind, placebo-controlled pilot study to investigate whether supplemental Nitric Oxide (NO) gas delivered during cardiac surgery with cardiopulmonary bypass (CPB) reduces the incidence and impact of acute kidney injury (AKI) in neonates undergoing surgery for congenital heart disease (CHD), when compared to placebo gas

Description:

Screening: All patients undergoing either elective or emergency cardiac surgery will be screened against the eligibility criteria.

Research Sample Collection: Blood and urine will be collected for the first 48 hours admission and analyzed. The specific time points for these parameters will be: 2 hours, 6 hours, 12 hours 24 hours, and 48 hours post admission. Blood and urine parameters will also be collected as a baseline pre-operative. Patient outcomes will be captured for 30 days post operatively.

Research Data Collection: Baseline information will be collected. Other research related variables collected during the surgical intervention and bypass. Additional information will be collected 2 hours, 6 hours, 12 hours, 24 hours, and 48 hours after admission as well as outcomes 30 days after the procedure.

Participants will be randomly allocated to the NO or control group in a 1:1 ratio.

This study is investigating a possible protective role for NO gas administration during bypass on the subsequent development of AKI. NO is typically delivered via large, stand-alone cylinders that are placed at the bedside (or adjacent to the patient) and is set up by respiratory therapists. In this research study, the study gas (NO or placebo) will be delivered directly into the bypass circuit at a constant gas flow. The placebo gas in this study will be 21% (or atmospheric) oxygen, and will appear to all members of the clinical and research teams (with the exception of the respiratory therapist responsible for setting it up) indistinguishable from NO, rendering this a double-blind study for the patient (or caregiver) and the investigators. This minimizes any possibility of bias in the study.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 2023
• Est. primary completion date: October 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 30 Days

Eligibility

Inclusion Criteria:

• Age: </= 30 days

• Gestational age: 38 weeks

• Diagnosis: Congenital Heart Disease (CHD)

• Planned surgery to include cardiopulmonary bypass (CPB )for underlying CHD

• Consent of parent/guardian

Exclusion Criteria:

• Currently receiving or has received inhaled nitric oxide (NO) or other nitrogen donors such as sildenafil or nitroprusside

• Pre-existing acute kidney injury (AKI) as per the AKIN criteria;

• Cardiac arrest within one week prior consent;

• Prior cardiac surgery with CPB procedure;

• Prior history of Extra Corporeal Membrane Oxygenation (ECMO)

• Use of another investigational drug.

Related Conditions & MeSH terms

• Acute Kidney Injury
• Congenital Heart Disease
• Heart Defects, Congenital
• Heart Diseases

Intervention

Drug:
• NO gas delivered during cardiac surgery
intra-operative NO gas at 20ppm blended into the fresh gas flow of the CPB oxygenator via the INOMax delivery system.

Other:
• placebo gas delivered during cardiac surgery
placebo blended into the fresh gas flow of the CPB oxygenator via the INOMax delivery system. The placebo gas in this study will be 21% (or atmospheric) oxygen.

Locations

Country	Name	City	State
United States	Texas Children's Hospital	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Fabio Savorgnan	Mallinckrodt

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	NGAL level	1 of 2 biomarkers to determine acute kidney injury (AKI)	48 hours
Primary	Cystatin-C level	2 of 2 biomarkers to determine acute kidney injury (AKI)	48 hours