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.

BMJ Open
|August 18, 2019
PubMed

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.
Abstract

Related Concept Videos

Nitric Oxide Signaling Pathway01:28

Nitric Oxide Signaling Pathway

Nitric oxide (NO), an inorganic gas, acts as a potent second messenger in most animal and plant tissues. NO diffuses out of the cells that produce it and enters the neighboring cells to generate a downstream response. NO synthase (NOS) catalyzes NO production by the deamination of the amino acid arginine. There are three isoforms of NOS. Endothelial cells have endothelial NOS (eNOS), nerve and muscle cells have neuronal NOS (nNOS), and macrophages produce inducible NOS (iNOS) upon exposure...
6.2K
Clinical Trials01:16

Clinical Trials

Clinical trials are prospective experimental studies conducted on humans to determine the safety and efficacy of treatments, drugs, diet methods, and medical devices. Using statistics in clinical trials enables researchers to derive reasonable and accurate conclusions from the collected data, allowing them to make wise decisions in uncertain situations. In medical research, statistical methods are crucial for preventing errors and bias.
There are four phases in a clinical trial. A phase one...
10.2K
Clinical Trials: Overview01:11

Clinical Trials: Overview

Clinical development focuses on how the drug will interact with the human body and encompasses four key phases of clinical trials, each serving a specific purpose in assessing the safety and effectiveness of new drugs. These phases overlap and build upon one another. Phase I involves a small group of healthy volunteers (typically 20-80 individuals) or, in cases where significant toxicity is expected, patients with the targeted disease, such as cancer or AIDS. The volunteers are tested for...
4.6K
Trial and Error and Algorithm01:12

Trial and Error and Algorithm

A problem-solving strategy is a plan of action used to find a solution. Different strategies have distinct action plans. Trial and error involves trying different solutions until one works. For instance, to fix a broken printer, you might check ink levels, ensure the paper tray isn't jammed, and verify the printer's connection to your laptop. This method can be time-consuming but is commonly used. Thomas Edison, for example, used trial and error to find a suitable filament for the light...
398
Statistical Software for Data Analysis and Clinical Trials01:12

Statistical Software for Data Analysis and Clinical Trials

Statistical software is pivotal in data analysis and clinical trials by providing tools to analyze data, draw conclusions, and make predictions. These software packages range from simple data management applications to complex analytical platforms, supporting various statistical tests, models, and simulation techniques. Their significance lies in their ability to handle vast amounts of data with precision and efficiency, enabling researchers to validate hypotheses, identify trends, and make...
1.4K
Bioequivalence Experimental Study Designs: Completely Randomized and Randomized Block Designs01:20

Bioequivalence Experimental Study Designs: Completely Randomized and Randomized Block Designs

Body:Bioequivalence experimental study designs are crucial methodologies used in evaluating and comparing the bioavailability of different drug products. These designs are categorized into various types: completely randomized, randomized block, repeated measures, cross and carry-over, and Latin square designs.Completely randomized designs involve randomly allocating treatments to all subjects participating in the experiment. This allocation is achieved by assigning unique random numbers to...
241