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Trial registered on ANZCTR


Registration number
ACTRN12615001376538
Ethics application status
Approved
Date submitted
12/12/2015
Date registered
17/12/2015
Date last updated
17/12/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
The addition of nitric oxide to cardiopulmonary bypass in children - a randomised controlled trial
Scientific title
In cardiac surgery for children on cardiopulmonary bypass, does the addition of nitric oxide to the bypass circuit, compared to not adding nitric oxide, reduce low cardiac output syndrome?
Secondary ID [1] 287878 0
nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
congenital heart disease 296765 0
low cardiac output syndrome 296766 0
Condition category
Condition code
Cardiovascular 297002 297002 0 0
Other cardiovascular diseases
Surgery 297293 297293 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Nitric Oxide was blended with oxygen in the gas administration line to the cpb (cardiopulmonary bypass) circuit, for the duration of cpb which was dependent on procedure (range 30 to 240 mins).
Nitric oxide was delivered at 20 parts per million (Ikaria delivery system which measures concentration of nitric oxide delivery electrochemically)
Methaemoglobin levels were monitored throughout cpb by the study perfusionist (who was unblinded to whether nitric oxide was to be delivered). Levels were higher in those that received nitric oxide (proving adherence - nitric oxide was indeed being delivered) but never reached clinically important levels.
Intervention code [1] 293248 0
Treatment: Other
Comparator / control treatment
standard cpb (oxygen alone, compared to oxygen and nitric oxide)
Control group
Active

Outcomes
Primary outcome [1] 296597 0
Proportion of patients with low cardiac output was the specific primary outcome.
This was defined as a (on ICU) a blood lactate >4 with mixed venous saturation <60% OR vasoactive inotrope score greater or equal to 10 (ie a high inotrope requirement), OR need for ECMO support.
Timepoint [1] 296597 0
within 48 hrs of admission to icu post-operative
Secondary outcome [1] 318845 0
Duration of ventilation
Assessed by review of hospital records
Timepoint [1] 318845 0
Total time on ventilation during ICU stay
Secondary outcome [2] 319570 0
ICU length of stay
Assessed by review of hospital records
Timepoint [2] 319570 0
Time from ICU admission following surgery to ICU discharge
Secondary outcome [3] 319571 0
Hospital length of stay
Assessed by review of hospital records
Timepoint [3] 319571 0
Time from end of procedure to hospital discharge

Eligibility
Key inclusion criteria
any child undergoing cpb for congenital heart disease
Minimum age
No limit
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
emergency cases
children requiring inhaled nitric oxide prior to surgery

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
A patient was deemed eligible for inclusion at the time of consent, before randomisation.
Randomisation was performed just prior to starting cpb by the study perfusionist. He/she opened a sealed opaque envelope (from centre for epidemiology and biostatistics) which told him/her whether to add nitric oxide to the cpb gas flow or not.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The centre for epidemiology and biostatistics at RCH performed simple randomisation using a randomisation table created by computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving 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
A statistician employed by hospital was used.
The incidence of LCOS following cardiac surgery is around 50%. A pilot study suggested this could be reduced to 30% using the intervention being studied.. In order to detect a reduction in LCOS from 50% to 30% (effect size), where alpha (level of statistical significance) is 0.05 and beta 0.2 (80% power) a sample size of 186 participants was calculated. Attrition rate was zero as loss to follow up not possible (the children were not followed up after discharge from hospital and data was available from hospital records for the entirety of their stay).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
3/01/2014
Date of last participant enrolment
Anticipated
Actual
23/12/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
186
Accrual to date
Final
198
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 4623 0
The Royal Childrens Hospital - Parkville

Funding & Sponsors
Funding source category [1] 292376 0
Self funded/Unfunded
Name [1] 292376 0
Nil
Country [1] 292376 0
Primary sponsor type
Hospital
Name
Intensive Care Unit, Royal Childrens' Hospital, Melbourne
Address
50 Flemington Road
Parkville
Melbourne VIC 3052
Country
Australia
Secondary sponsor category [1] 291063 0
None
Name [1] 291063 0
Nil
Address [1] 291063 0
Nil
Country [1] 291063 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294022 0
RCH ethics committee
Ethics committee address [1] 294022 0
Ethics committee country [1] 294022 0
Australia
Date submitted for ethics approval [1] 294022 0
01/05/2013
Approval date [1] 294022 0
13/12/2013
Ethics approval number [1] 294022 0
33112B

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 61510 0
Dr Christopher James
Address 61510 0
Paediatric Intensive Care Unit
Royal Children's Hospital
50 Flemington Road
Parkville
VIC 3056
Country 61510 0
Australia
Phone 61510 0
+61 3 9345 5211
Fax 61510 0
Email 61510 0
Christopher.James@rch.org.au
Contact person for public queries
Name 61511 0
Christopher James
Address 61511 0
Paediatric Intensive Care Unit
Royal Children's Hospital
50 Flemington Road
Parkville
VIC 3056
Country 61511 0
Australia
Phone 61511 0
+61 3 9345 5211
Fax 61511 0
Email 61511 0
Christopher.James@rch.org.au
Contact person for scientific queries
Name 61512 0
Christopher James
Address 61512 0
Paediatric Intensive Care Unit
Royal Children's Hospital
50 Flemington Road
Parkville
VIC 3056
Country 61512 0
Australia
Phone 61512 0
+61 3 9345 5211
Fax 61512 0
Email 61512 0
Christopher.James@rch.org.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseNitric oxide administration during paediatric cardiopulmonary bypass: a randomised controlled trial.2016https://dx.doi.org/10.1007/s00134-016-4420-6
N.B. These documents automatically identified may not have been verified by the study sponsor.