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Trial registered on ANZCTR


Registration number
ACTRN12612000756820
Ethics application status
Approved
Date submitted
16/07/2012
Date registered
16/07/2012
Date last updated
18/11/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Study of the control of oxygen levels during cardiopulmonary bypass - the SO-COOl study
Scientific title
Study of patients undergoing cardiopulmonary bypass to compare the effects of normoxia vs hyperoxia on organ function
Secondary ID [1] 280852 0
Nil
Universal Trial Number (UTN)
U1111-1132-6953
Trial acronym
The SO-COOL study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiothoracic surgery 286919 0
Condition category
Condition code
Cardiovascular 287247 287247 0 0
Other cardiovascular diseases
Surgery 287248 287248 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
During anaesthesia SpO2 will be kept at 92-95% and during CPB the oxygen tension of the arterial return blood flow will be kept at 10 - 12 kPa using continuous in-line real-time blood gas monitoring (Terumo CDI 500, Terumo Corporation).
Intervention code [1] 285279 0
Treatment: Other
Comparator / control treatment
Patients randomsied to the control group will receive standard care, including selection of appropriate supplemental oxygen by the treating anaesthetist and clinical perfusionist.
Control group
Active

Outcomes
Primary outcome [1] 292048 0
Difference in CSA-AKI as demonstrated by KDIGO classification
Timepoint [1] 292048 0
During hospital admission
Secondary outcome [1] 298336 0
Change in serum Troponin T, AST, C-reactive protein, selenium and amylase measured by blood sampling.
Timepoint [1] 298336 0
6 hours and 24 hours post commencement of cardiopulmonary bypass
Secondary outcome [2] 298337 0
Length of intensive care unit stay recorded as time of admission to time of discharge.
Timepoint [2] 298337 0
Discharge from Intensive care unit
Secondary outcome [3] 298338 0
Hospital length of stay recorded as time of admission to time of discharge.
Timepoint [3] 298338 0
Discharge from hospital
Secondary outcome [4] 298339 0
Duration of mechanical ventilation - from time of admission to ICU to time of extubation
Timepoint [4] 298339 0
At discontinuation of mechanical ventilation
Secondary outcome [5] 298340 0
Development of acute kidney injury defined according to RIFLE and AKIN classification
Timepoint [5] 298340 0
During hospital stay
Secondary outcome [6] 298341 0
Time to "readiness for ward discharge from the ICU"
Timepoint [6] 298341 0
When a patient is no longer requiring ICU/HDU level cardiovascular or respiratory support
Defined as:
- Any continuous infusions of vasoactive agents except up to 5mcg/kg/min of Dopamine or Dobutamine
- Requiring more than 40% FiO2 or 40L/min flow if receiving high flow oxygen therapy or any non-invasive ventilation, excluding the continuation of treatment of OSA.

Eligibility
Key inclusion criteria
Adult patient (over 16 yrs)
Scheduled to have cardiac surgery using cardiopulmonary bypass
Written informed consent obtained
Minimum age
16 Years
Maximum age
100 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Preoperative acute renal failure within 6 weeks (acute rise in serum creatinine >50% from baseline) is present or
Pre-operative end stage renal disease (serum creatinine >300 µmol/L) is present or receiving any form of renal replacement therapy or
Pre-operative hepatic dysfunction (AST> 2* upper limit of normal) or
Recent (< 6 weeks) cerebrovascular event, (Including CVA,TIA or intracerebral bleed) or
Pregnant

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)
Allocation concealment will be achieved through the use of sequentially numbered, opaque, sealed envelopes. These envelopes will contain the unique patient identifier code and allocated study therapy details.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Patients will be randomised 1:1 to the intervention or standard care. Subjects will be stratified into “high risk of AKI” and “low risk of AKI” using well recognised criteria.
The randomisation sequence will be generated by an independent statistician using computer-generated random numbers to ensure even distribution of the stratification factor across both arms and to minimise the predictability of the allocation sequence. Participants will be randomised to treatment just prior to surgery.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/09/2012
Actual
19/12/2012
Date of last participant enrolment
Anticipated
31/05/2014
Actual
13/05/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
286
Accrual to date
Final
298
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 1767 0
Calvary Wakefield Hospital - Adelaide
Recruitment postcode(s) [1] 7584 0
5000 - Adelaide
Recruitment outside Australia
Country [1] 4409 0
New Zealand
State/province [1] 4409 0

Funding & Sponsors
Funding source category [1] 285638 0
Charities/Societies/Foundations
Name [1] 285638 0
Green Lane Research and Education Fund
Country [1] 285638 0
New Zealand
Funding source category [2] 292412 0
Government body
Name [2] 292412 0
Health Research Council of New Zealand
Country [2] 292412 0
New Zealand
Primary sponsor type
Individual
Name
Dr Shay McGuinness
Address
Cardiothoracic and Vascular Intensive Care Unit
Auckland City Hospital
Private Bag 92024
Auckland 1142
Country
New Zealand
Secondary sponsor category [1] 284473 0
None
Name [1] 284473 0
Address [1] 284473 0
Country [1] 284473 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287638 0
Northern Y Ethics Committee
Ethics committee address [1] 287638 0
Ministry of Health
No 1 The Terrace
PO Box 5013
Wellington 6011
Ethics committee country [1] 287638 0
New Zealand
Date submitted for ethics approval [1] 287638 0
20/07/2012
Approval date [1] 287638 0
17/09/2012
Ethics approval number [1] 287638 0

Summary
Brief summary
Heart surgery is a common procedure, with more than 2500 operations each year in New Zealand. Damage to organs, including kidneys, liver and heart is common after heart surgery and some of the damage may be caused by extra oxygen given on cardiopulmonary bypass. This study will randomise patients to receive normal levels of oxygen or the traditional high levels during heart surgery. Endpoints include a number of blood tests that are very sensitive for detecting damage to the kidney, liver, heart and other organs. In total 286 patients having heart surgery at Auckland City Hospital will be included in this study over a two year period.
Trial website
Trial related presentations / publications
Rachael Parke. The avoidance of hyperoxaemia during cardiopulmonary bypass: a multi-centre phase IIb randomized controlled trial. ANZICS-ASM 2015, October 29th 2015, Auckland
Public notes

Contacts
Principal investigator
Name 34442 0
Dr Shay McGuinness
Address 34442 0
Cardiothoracic and Vascular Intensive Care Unit Auckland City Hospital
Private Bag 92024
Auckland 1142
Country 34442 0
New Zealand
Phone 34442 0
+6421324771
Fax 34442 0
+6493074906
Email 34442 0
[email protected]
Contact person for public queries
Name 17689 0
Rachael Parke
Address 17689 0
Cardiothoracic and Vascular Intensive Care Unit
Auckland City Hospital
Private Bag 92024
Auckland 1142
Country 17689 0
New Zealand
Phone 17689 0
+6421893176
Fax 17689 0
+6493074906
Email 17689 0
[email protected]
Contact person for scientific queries
Name 8617 0
Shay McGuinness
Address 8617 0
Cardiothoracic and Vascular Intensive Care Unit
Auckland City Hospital
Private Bag 92024
Auckland 1142
Country 8617 0
New Zealand
Phone 8617 0
+6421324771
Fax 8617 0
+6493074906
Email 8617 0
[email protected]

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
EmbaseA multicenter, randomized, controlled Phase IIb trial of avoidance of hyperoxemia during cardiopulmonary bypass.2016https://dx.doi.org/10.1097/ALN.0000000000001226
N.B. These documents automatically identified may not have been verified by the study sponsor.