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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]

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

Post-operative atrial fibrillation

Condition category

Condition code

Cardiovascular

Coronary heart disease

Surgery

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]

Not applicable

Comparator / control treatment

uncontrolled

Control group

Uncontrolled

Outcomes

Primary outcome [1]

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]

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]

Monitoring Lung dysfunction after cardiac surgery (length of mechanical ventilation) and comparing to oxidative stress levels

Timepoint [1]

Time to extubation compared with 24 hr blood sample of oxidative stress

Secondary outcome [2]

Length of ICU stay versus pre-operative selenium levels

Timepoint [2]

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?

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]

Government body

Name [1]

Queensland Health-Health Practitioner Research Grant Scheme

Address [1]

Allied Health Workforce Advice and Coordination Unit

Level 6, Queensland Health Building
147-163 Charlotte Street
BRISBANE QLD 4000

Country [1]

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]

Individual

Name [1]

John Fraser

Address [1]

Adult Intensive Care Unit
The Prince Charles Hospital
Rode Rd
Chermside
Qld, 4032

Country [1]

Australia

Other collaborator category [1]

Individual

Name [1]

Yoke Lin Fung

Address [1]

Level 3
Clinical Sciences Building
The Prince Charles Hospital
Rode Rd
Chermside
Qld, 4032

Country [1]

Australia

Other collaborator category [2]

Individual

Name [2]

Andrew Clarke

Address [2]

Cardiac Surgical Department
Level 1
The Prince Charles Hospital
Rode Rd
Chermside
Qld, 4032

Country [2]

Australia

Other collaborator category [3]

Individual

Name [3]

Bronwyn Pearse

Address [3]

Level 5
Clinical Sciences Building
The Prince Charles Hospital
Rode Rd
Chermside
Qld, 4032

Country [3]

Australia

Other collaborator category [4]

Individual

Name [4]

Sarah Gabriel

Address [4]

Level 5
Clinical Science Building
The Prince Charles Hospital
Rode Rd
Chermside
Qld, 4032

Country [4]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

The Prince Charles Hospital HREC

Ethics committee address [1]

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]

Australia

Date submitted for ethics approval [1]

Approval date [1]

14/10/2011

Ethics approval number [1]

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

Address

Country

Phone

Fax

Contact person for public queries

Name

Bronwyn Pearse

Address

Level 5
Clinical Sciences Building
The Prince Charles Hospital
Rode Rd
Chermside
Qld, 4032

Country

Australia

Phone

+61 7 3139 5413

Fax

+61 7 3139 6140

[email protected]

Contact person for scientific queries

Name

Charles McDonald

Address

Main Operating Theatre
Level 2
The Prince Charles Hospital
Rode Rd
Chermside
Qld, 4032

Country

Australia

Phone

+61 7 3139 4705

Fax

+61 7 3139 4659

[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

No additional documents have been identified.

Trial Review

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