Related Experiment Video
Updated: Jan 20, 2026

Procedures of Laboratory Fumigation for Pest Control with Nitric Oxide Gas
Published on: November 24, 2017
Study protocol: NITric oxide during cardiopulmonary bypass to improve Recovery in Infants with Congenital heart
Luregn J Schlapbach1,2, Stephen Brian Horton3,4,5, Debbie Amanda Long1,2
1Paediatric Critical Care Research Group, Child Health Research Institute, The University of Queensland, Brisbane, Queensland, Australia.
Insights
Nitric oxide (NO) delivered during cardiopulmonary bypass (CPB) may improve recovery for infants undergoing heart surgery. The NITRIC trial investigates if NO increases ventilator-free days (VFD) in these young patients.
Area of Science:
- Cardiovascular Surgery
- Pediatric Cardiology
- Critical Care Medicine
Background:
- Congenital heart disease (CHD) is a leading cause of infant mortality, often requiring surgery with cardiopulmonary bypass (CPB).
- CPB can induce a systemic inflammatory response, leading to complications like low cardiac output syndrome (LCOS), increased morbidity, and mortality.
- Nitric oxide (NO) delivered during CPB may offer myocardial protection and reduce inflammation, potentially improving patient recovery.
Purpose of the Study:
- To investigate the efficacy of administering nitric oxide (NO) during cardiopulmonary bypass (CPB) in pediatric cardiac surgery.
- To determine if NO administration increases ventilator-free days (VFD) up to day 28 post-surgery compared to standard care.
- To assess secondary outcomes including LCOS, need for extracorporeal membrane oxygenation, mortality, length of stay, and healthcare costs.
Main Methods:
- A randomized, double-blind, controlled, parallel-group superiority trial involving 1320 infants under 2 years undergoing cardiac surgery with CPB.
- Participants are randomized 1:1 to receive NO at 20 ppm during CPB or standard care.
- Stratification by age, single ventricle physiology, and study center. Primary outcome is VFD to day 28. Intention-to-treat analysis.
Main Results:
- This section describes the study protocol and does not contain results.
- The study is designed to provide data on the primary outcome of ventilator-free days (VFD) and secondary outcomes.
- Further analyses will explore the impact of NO on postoperative inflammatory profiles.
Conclusions:
- The NITRIC trial protocol is established to evaluate the clinical benefits of NO during CPB in infants with CHD.
- Findings are expected to inform clinical practice regarding the use of NO to mitigate CPB-induced complications and improve outcomes in pediatric cardiac surgery.
- The study aims to provide robust evidence on the effectiveness of NO in enhancing recovery and reducing morbidity in this vulnerable population.
Introduction:
Congenital heart disease (CHD) is a major cause of infant mortality. Many infants with CHD require corrective surgery with most operations requiring cardiopulmonary bypass (CPB). CPB triggers a systemic inflammatory response which is associated with low cardiac output syndrome (LCOS), postoperative morbidity and mortality. Delivery of nitric oxide (NO) into CPB circuits can provide myocardial protection and reduce bypass-induced inflammation, leading to less LCOS and improved recovery. We hypothesised that using NO during CPB increases ventilator-free days (VFD) (the number of days patients spend alive and free from invasive mechanical ventilation up until day 28) compared with standard care. Here, we describe the NITRIC trial protocol.
Methods And Analysis:
The NITRIC trial is a randomised, double-blind, controlled, parallel-group, two-sided superiority trial to be conducted in six paediatric cardiac surgical centres. One thousand three-hundred and twenty infants <2 years of age undergoing cardiac surgery with CPB will be randomly assigned to NO at 20 ppm administered into the CPB oxygenator for the duration of CPB or standard care (no NO) in a 1:1 ratio with stratification by age (<6 and ≥6 weeks), single ventricle physiology (Y/N) and study centre. The primary outcome will be VFD to day 28. Secondary outcomes include a composite of LCOS, need for extracorporeal membrane oxygenation or death within 28 days of surgery; length of stay in intensive care and in hospital; and, healthcare costs. Analyses will be conducted on an intention-to-treat basis. Preplanned secondary analyses will investigate the impact of NO on host inflammatory profiles postsurgery.
Ethics And Dissemination:
The study has ethical approval (HREC/17/QRCH/43, dated 26 April 2017), is registered in the Australian New Zealand Clinical Trials Registry (ACTRN12617000821392) and commenced recruitment in July 2017. The primary manuscript will be submitted for publication in a peer-reviewed journal.
Trial Registration Number:
ACTRN12617000821392.
Related Concept Videos
Nitric Oxide Signaling Pathway
Clinical Trials
There are four phases in a clinical trial. A phase one...
Clinical Trials: Overview
Trial and Error and Algorithm
Statistical Software for Data Analysis and Clinical Trials
Bioequivalence Experimental Study Designs: Completely Randomized and Randomized Block Designs

