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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03661385




Registration number
NCT03661385
Ethics application status
Date submitted
4/09/2018
Date registered
7/09/2018
Date last updated
18/04/2024

Titles & IDs
Public title
Nitric Oxide During Bypass for Arterial Switch Operation
Scientific title
A Randomised Controlled Trial of Nitric Oxide Administration During Cardiopulmonary Bypass in Infants Undergoing Arterial Switch Operation for Repair of Transposition of the Great Arteries
Secondary ID [1] 0 0
ACTRN12618000089235p
Secondary ID [2] 0 0
38017
Universal Trial Number (UTN)
Trial acronym
NASO
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Low Cardiac Output Syndrome 0 0
Transposition of Great Vessels 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Other cardiovascular diseases
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Nitric Oxide

Active comparator: Intervention arm - • Intervention arm will receive nitric oxide 20 parts per million (ppm) into the oxygenator of a cardio-pulmonary bypass circuit

No intervention: Control arm - Control arm will not receive nitric oxide, they will receive standard bypass as per local policy


Treatment: Drugs: Nitric Oxide
Addition of nitric oxide 20ppm into bypass circuit
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Major adverse events
Timepoint [1] 0 0
28 days post intervention
Secondary outcome [1] 0 0
Length of stay in ICU (hours)
Timepoint [1] 0 0
This will be calculated from date and time of admission to ICU to date and time of discharge from ICU in hours up to 28 days
Secondary outcome [2] 0 0
Length of stay in hospital (days)
Timepoint [2] 0 0
28 days (or until hospital discharge)
Secondary outcome [3] 0 0
Ventilator-free days
Timepoint [3] 0 0
28 days (or until ICU discharge)
Secondary outcome [4] 0 0
Inotrope hours
Timepoint [4] 0 0
Number of hours inotropes have been administered during first 28 days post operatively
Secondary outcome [5] 0 0
Dialysis-free days
Timepoint [5] 0 0
28 days (or until ICU discharge)
Secondary outcome [6] 0 0
Inhaled NO hours
Timepoint [6] 0 0
Number of hours inhaled NO have been administered during first 28 days post operatively
Secondary outcome [7] 0 0
ECMO-free days
Timepoint [7] 0 0
28 days (or until ICU discharge)
Secondary outcome [8] 0 0
Closed sternum days
Timepoint [8] 0 0
28 days (or until ICU discharge)
Secondary outcome [9] 0 0
Composite free-day score
Timepoint [9] 0 0
28 days (or until hospital discharge)

Eligibility
Key inclusion criteria
Inclusion criteria;

Each participant must meet all of the following criteria to be enrolled in this study:

* Infant aged greater than or equal to 36 weeks gestation
* Infants less than 2 years
* Diagnosed with TGA and requiring Arterial Switch Operation
* Consent of parents/guardian.
Minimum age
0 Days
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria

Potential participants will be excluded if they meet any of the following criteria:

* They have multiple major congenital anomalies (anomalies which affect the infant's life expectancy or health status)
* They have multiple other cardiac abnormalities (with the exception of ASD, VSD or PDA)
* They weigh less than 2.2kgs.
* Prior surgical exposure to cardio-pulmonary bypass

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
11/07/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
23/04/2023
Sample size
Target
Accrual to date
Final
300
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Royal Children's Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
3050 - Melbourne
Recruitment outside Australia
Country [1] 0 0
Canada
State/province [1] 0 0
Alberta
Country [2] 0 0
Indonesia
State/province [2] 0 0
Jakarta
Country [3] 0 0
Malaysia
State/province [3] 0 0
Kuala Lumpur

Funding & Sponsors
Primary sponsor type
Other
Name
Murdoch Childrens Research Institute
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This trial will test if adding nitric oxide (NO) gas to the cardiopulmonary bypass (CPB) circuit in infants undergoing an arterial switch operation (ASO) for Transposition of the Great Arteries (TGA) changes the incidence of major postoperative adverse events (AEs).

Major postoperative AEs include cardiac arrest, emergency chest opening, use of ECMO (machine that acts as an artificial heart and lung during surgery), and death.

Participants will be randomised to receive oxygen plus nitric oxide (intervention arm) or oxygen without nitric oxide (control arm) during CPB.
Trial website
https://clinicaltrials.gov/study/NCT03661385
Trial related presentations / publications
Chello M, Mastroroberto P, Perticone F, Celi V, Colonna A. Nitric oxide modulation of neutrophil-endothelium interaction: difference between arterial and venous coronary bypass grafts. J Am Coll Cardiol. 1998 Mar 15;31(4):823-6. doi: 10.1016/s0735-1097(97)00560-3.
Hataishi R, Rodrigues AC, Neilan TG, Morgan JG, Buys E, Shiva S, Tambouret R, Jassal DS, Raher MJ, Furutani E, Ichinose F, Gladwin MT, Rosenzweig A, Zapol WM, Picard MH, Bloch KD, Scherrer-Crosbie M. Inhaled nitric oxide decreases infarction size and improves left ventricular function in a murine model of myocardial ischemia-reperfusion injury. Am J Physiol Heart Circ Physiol. 2006 Jul;291(1):H379-84. doi: 10.1152/ajpheart.01172.2005. Epub 2006 Jan 27.
Levy JH, Tanaka KA. Inflammatory response to cardiopulmonary bypass. Ann Thorac Surg. 2003 Feb;75(2):S715-20. doi: 10.1016/s0003-4975(02)04701-x.
Zahler S, Massoudy P, Hartl H, Hahnel C, Meisner H, Becker BF. Acute cardiac inflammatory responses to postischemic reperfusion during cardiopulmonary bypass. Cardiovasc Res. 1999 Mar;41(3):722-30. doi: 10.1016/s0008-6363(98)00229-6.
Checchia PA, Bronicki RA, Muenzer JT, Dixon D, Raithel S, Gandhi SK, Huddleston CB. Nitric oxide delivery during cardiopulmonary bypass reduces postoperative morbidity in children--a randomized trial. J Thorac Cardiovasc Surg. 2013 Sep;146(3):530-6. doi: 10.1016/j.jtcvs.2012.09.100. Epub 2012 Dec 8.
James C, Millar J, Horton S, Brizard C, Molesworth C, Butt W. Nitric oxide administration during paediatric cardiopulmonary bypass: a randomised controlled trial. Intensive Care Med. 2016 Nov;42(11):1744-1752. doi: 10.1007/s00134-016-4420-6. Epub 2016 Sep 30.
Public notes

Contacts
Principal investigator
Name 0 0
Warwick Butt
Address 0 0
MRCI
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT03661385