Nitric Oxide During CPB to Reduce AKI in Neonates

• ClinicalTrials.gov Identifier: NCT03946462
• Recruitment Status: Withdrawn
• First Posted: May 10, 2019
• Last Update Posted: December 1, 2021
• Sponsor: Fabio Savorgnan
• Collaborator: Mallinckrodt
• Information provided by (Responsible Party): Fabio Savorgnan, Baylor College of Medicine

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 (Clinical Trial)
• 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
• Estimated Study Start Date: October 2021
• Estimated Primary Completion Date: October 2022
• Estimated Study Completion Date: March 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.

Outcome Measures

Primary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: up to 30 Days (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Locations

United States, Texas

Texas Children's Hospital

Houston, Texas, United States, 77030

Sponsors and Collaborators

Fabio Savorgnan

Mallinckrodt

Investigators

• Principal Investigator: Fabio Savorgnan, MD; Texas Children's Hospital / Baylor College of Medicine

More Information

• Responsible Party: Fabio Savorgnan, Principal Investigator / Assistant Professor, Baylor College of Medicine
• ClinicalTrials.gov Identifier: NCT03946462
• Other Study ID Numbers: H-44435
• First Posted: May 10, 2019
• Last Update Posted: December 1, 2021
• Last Verified: November 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

Keywords provided by Fabio Savorgnan, Baylor College of Medicine:

Congenital Heart Disease; CHD; Acute Kidney Injury; AKI; Cardiopulmonary bypass; CPB; cardiac surgery; neonate; infant; nitric oxide; NO; gestational age

Additional relevant MeSH terms:

Acute Kidney Injury; Heart Diseases; Heart Defects, Congenital; Cardiovascular Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Cardiovascular Abnormalities; Congenital Abnormalities