Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000934842
Ethics application status
Approved
Date submitted
3/09/2012
Date registered
3/09/2012
Date last updated
4/10/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Oxidative Stress in Coronary Artery Surgery
Scientific title
Antioxidant response, Oxidative stress and Post-operative Atrial Fibrillation after high risk cardiac surgery
Secondary ID [1] 281125 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
OSCArS study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Post-operative outcomes after Cardiovascular surgery 287294 0
Post-operative atrial fibrillation 287295 0
Condition category
Condition code
Cardiovascular 287625 287625 0 0
Coronary heart disease
Surgery 287644 287644 0 0
Other surgery

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Comparing the development of post-operative atrial fibrillation with oxidative stress and selenium levels in two risk groups of cardiac patients. Patients will have blood taken up to 5 days post-surgery to assess oxidative stress and selenium levels
Intervention code [1] 285583 0
Not applicable
Comparator / control treatment
uncontrolled
Control group
Uncontrolled

Outcomes
Primary outcome [1] 287873 0
In two different risk groups of patients having coronary artery surgery we will measure selenium levels and oxidative stress markers at various time points to see if an association exists between these markers and the development of post-operative atrial fibrillation. Oxidative stress will be measured by using the lipid peroxidation marker malondialdehyde.
Timepoint [1] 287873 0
Blood samples at following time points

Anaesthetic induction
Removal of aortic cross clamp
3 hours after separation from cardiopulmonary bypass
24 hours after separation from cardiopulmonary bypass
5 days post-surgery
Secondary outcome [1] 298970 0
Monitoring Lung dysfunction after cardiac surgery (length of mechanical ventilation) and comparing to oxidative stress levels
Timepoint [1] 298970 0
Time to extubation compared with 24 hr blood sample of oxidative stress
Secondary outcome [2] 298971 0
Length of ICU stay versus pre-operative selenium levels
Timepoint [2] 298971 0
selenium level at Anaesthetic induction

Eligibility
Key inclusion criteria
Primary CABG
STS score <0.3 or > 2.0
Minimum age
18 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pre-operative atrial fibrillation
pacemaker
pre-operative steroids
previous cardiac surgery
off pump surgery
STS score >0.3 <2.0

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/10/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 285905 0
Government body
Name [1] 285905 0
Queensland Health-Health Practitioner Research Grant Scheme
Country [1] 285905 0
Australia
Primary sponsor type
Individual
Name
Charles McDonald
Address
Main Operating Theatre
Level 2
The Prince Charles Hospital
Rode Rd
Chermside
Qld, 4032
Country
Australia
Secondary sponsor category [1] 284727 0
Individual
Name [1] 284727 0
John Fraser
Address [1] 284727 0
Adult Intensive Care Unit
The Prince Charles Hospital
Rode Rd
Chermside
Qld, 4032
Country [1] 284727 0
Australia
Other collaborator category [1] 277046 0
Individual
Name [1] 277046 0
Yoke Lin Fung
Address [1] 277046 0
Level 3
Clinical Sciences Building
The Prince Charles Hospital
Rode Rd
Chermside
Qld, 4032
Country [1] 277046 0
Australia
Other collaborator category [2] 277047 0
Individual
Name [2] 277047 0
Andrew Clarke
Address [2] 277047 0
Cardiac Surgical Department
Level 1
The Prince Charles Hospital
Rode Rd
Chermside
Qld, 4032
Country [2] 277047 0
Australia
Other collaborator category [3] 277048 0
Individual
Name [3] 277048 0
Bronwyn Pearse
Address [3] 277048 0
Level 5
Clinical Sciences Building
The Prince Charles Hospital
Rode Rd
Chermside
Qld, 4032
Country [3] 277048 0
Australia
Other collaborator category [4] 277049 0
Individual
Name [4] 277049 0
Sarah Gabriel
Address [4] 277049 0
Level 5
Clinical Science Building
The Prince Charles Hospital
Rode Rd
Chermside
Qld, 4032
Country [4] 277049 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287936 0
The Prince Charles Hospital HREC
Ethics committee address [1] 287936 0
Research, Ethics & Governance Unit (REaGU)
Metro North Hospital & Health Services
The Prince Charles Hospital
Administration Building
Lower Ground, Rode Road
CHERMSIDE
Qld 4032
Ethics committee country [1] 287936 0
Australia
Date submitted for ethics approval [1] 287936 0
Approval date [1] 287936 0
14/10/2011
Ethics approval number [1] 287936 0
HREC/11/QPCH/138

Summary
Brief summary
Post-operative atrial fibrillation (POAF) is one of the most common complications after coronary artery surgery, affecting 20-50% of patients. It is a serious post surgical complication that is associated with increased morbidity and long-term health care costs. The development of this arrhythmia after surgery is multi-factorial and reliable pre-operative predictors have not been found. The inability to reliably predict patients at risk means that current methods of preventing POAF remain suboptimal. Mounting evidence suggests that increased reactive oxygen species and oxidative stress play a major part in POAF development, opening the possibility of antioxidant supplementation as a preventative measure. During cardiac surgery with cardiopulmonary bypass (CPB), increases in reactive oxygen species occurs after blood contact with the CPB circuit, the inflammatory response syndrome, ischemia-reperfusion and hyperoxia resulting in oxidative damage to myocytes. In addition there is also a reduced antioxidant response. Some of the primary antioxidants rely on appropriate levels of trace elements for normal function. One such trace element is selenium, which is required by the antioxidant glutathione peroxidase. Reductions in selenium during and after surgery are associated with increased mortality.

This observational study will measure oxidative stress levels (by malondialdehyde), as well as selenium levels, pre-, intra- and up to 5 days post-operatively, to determine if an association exists between these levels and the development of POAF. The study will separate participants into patients at low risk of post-operative mortality and those at high risk. In this way we hope to better define the effect of pre- and intra-operative low levels of selenium (and increases in oxidative stress) on events such as POAF. Understanding the pathophysiological differences of low selenium between various patient risk groups may lead to targeted pre-operative antioxidant therapies that have better success at preventing POAF.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34641 0
Address 34641 0
Country 34641 0
Phone 34641 0
Fax 34641 0
Email 34641 0
Contact person for public queries
Name 17888 0
Bronwyn Pearse
Address 17888 0
Level 5
Clinical Sciences Building
The Prince Charles Hospital
Rode Rd
Chermside
Qld, 4032
Country 17888 0
Australia
Phone 17888 0
+61 7 3139 5413
Fax 17888 0
+61 7 3139 6140
Email 17888 0
[email protected]
Contact person for scientific queries
Name 8816 0
Charles McDonald
Address 8816 0
Main Operating Theatre
Level 2
The Prince Charles Hospital
Rode Rd
Chermside
Qld, 4032
Country 8816 0
Australia
Phone 8816 0
+61 7 3139 4705
Fax 8816 0
+61 7 3139 4659
Email 8816 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
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