Nitric Oxide During CPB to Reduce AKI in Neonates

Sponsor

Fabio Savorgnan (Other)

Overall Status

Withdrawn

CT.gov ID

NCT03946462

Collaborator

Mallinckrodt (Industry)

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Congenital Heart Disease Acute Kidney Injury	Drug: NO gas delivered during cardiac surgery Other: placebo gas delivered during cardiac surgery	Phase 1

Detailed 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Masking Description:

subjects, caregivers and research team members are blinded while respiratory therapists are unblinded

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Oct 1, 2021

Anticipated Primary Completion Date :

Oct 1, 2022

Anticipated Study Completion Date :

Mar 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: NO Group	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.
Placebo Comparator: Placebo Group	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.

Arm

Intervention/Treatment

Experimental: NO Group

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.

Placebo Comparator: Placebo Group

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.

Outcome Measures

Primary Outcome Measures

NGAL level [48 hours]
1 of 2 biomarkers to determine acute kidney injury (AKI)
Cystatin-C level [48 hours]
2 of 2 biomarkers to determine acute kidney injury (AKI)

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 30 Days

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.