Nitric Oxide During CPB to Reduce AKI in Neonates

NCT03946462 | Withdrawn Phase 1 DMC FDA Drug

• 1 other identifier: H-44435
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Conditions

Congenital Heart Disease; Acute Kidney Injury

Keywords

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

Outcome Measures

Primary Outcomes (2)

• NGAL level

  1 of 2 biomarkers to determine acute kidney injury (AKI)

  48 hours

• Cystatin-C level

  2 of 2 biomarkers to determine acute kidney injury (AKI)

  48 hours

Study Arms (2)

NO Group

EXPERIMENTAL

Drug: NO gas delivered during cardiac surgery

Placebo Group

PLACEBO COMPARATOR

Other: placebo gas delivered during cardiac surgery

Interventions

NO gas delivered during cardiac surgery DRUG

intra-operative NO gas at 20ppm blended into the fresh gas flow of the CPB oxygenator via the INOMax delivery system.

NO Group

placebo gas delivered during cardiac surgery OTHER

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.

Placebo Group

Eligibility Criteria

• Age: Up to 30 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fabio Savorgnan: lead
• Mallinckrodt: collaborator

Study Sites (1)

Texas Children's Hospital

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Heart Defects, Congenital; Acute Kidney Injury

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Fabio Savorgnan, MD

  Texas Children's Hospital / Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: subjects, caregivers and research team members are blinded while respiratory therapists are unblinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator / Assistant Professor

Study Record Dates

• First Submitted: May 7, 2019
• First Posted: May 10, 2019
• Study Start: October 1, 2021
• Primary Completion: October 1, 2022
• Study Completion: March 1, 2023
• Last Updated: December 1, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)