Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12605000677606
Ethics application status
Approved
Date submitted
18/10/2005
Date registered
21/10/2005
Date last updated
21/10/2005
Type of registration
Prospectively registered

Titles & IDs
Public title
Cardioprotection for type II diabetic patients undergoing cardiopulmonary bypass: a comparison of 2 different anaesthetic agents.
Scientific title
A randomised phase IV study to compare the effects of propofol and sevoflurane in preventing myocardial necrosis in non-insulin dependent diabetes mellitus patients undergoing coronary artery bypass graft surgery requiring cardiopulmonary bypass.
Universal Trial Number (UTN)
Trial acronym
N/A
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Postoperative myocardial damage 825 0
Condition category
Condition code
Metabolic and Endocrine 890 890 0 0
Diabetes
Cardiovascular 891 891 0 0

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A comparison of 2 different anaesthetic agents (propofol and sevoflurane) and their affect on cardioprotection in non insulin diabetic patients undergoing coronary artery bypass graft surgery requiring cardiopulmonary bypass. 2 groups of 20 patients each will be randomised to receive either propofol or sevoflurane to maintain general anaesthesia whilst on cardiopulmonary bypass. Anaesthesia leading up to bypass will be the same in each group. At 15 minutes post separation from bypass, both groups will receive sevoflurane anaesthesia alone. Otherwise, management will be as per normal for coronary artery bypass patients.
Intervention code [1] 724 0
Prevention
Comparator / control treatment
Control group
Active

Outcomes
Primary outcome [1] 1155 0
Blood measurement of the enzyme cardiac troponin i
Timepoint [1] 1155 0
At 12 and 24 hours post-admission to the intensive care unit after coronary artery bypass graft surgery.
Secondary outcome [1] 2120 0
Inotrope use and other haemodynamic support, haemodynamic data.
Timepoint [1] 2120 0
In the first 24 hours postoperatively.

Eligibility
Key inclusion criteria
Non insulin dependent diabetes mellitus patients, undergoing routine, primary coronary artery bypass graft surgery requiring cardiopulmonary bypass.
Minimum age
Not stated
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Those with a sensitivity to propofol or its components, acute or evolving myocardial infarction, peroperative haemodynamic instability, hepatorenal dysfunction, off pump or valvular surgery.

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)
numbered, sealed envelopes. 20 for propofol and 20 for sevoflurane.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
coin toss to randomise the order of envelopes.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/01/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 983 0
Hospital
Name [1] 983 0
St Vincent's Hospital
Country [1] 983 0
Australia
Primary sponsor type
Hospital
Name
Dept of Anaesthesia
Address
Country
Secondary sponsor category [1] 847 0
None
Name [1] 847 0
Nil
Address [1] 847 0
Country [1] 847 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2292 0
St Vincent's Hospital
Ethics committee address [1] 2292 0
Melbourne
Ethics committee country [1] 2292 0
Australia
Date submitted for ethics approval [1] 2292 0
Approval date [1] 2292 0
Ethics approval number [1] 2292 0

Summary
Brief summary
Diabetic patients will be randomised to receive one of two commonly used anaesthetic drugs to maintain general anaesthesia whilst on cardiopulmonary bypass. We will be investigating which one offers better cardioprotection as determined by measuring an enzyme called cardiac troponin i. This enzyme is commonly measured to detect whther a myocardial infarction "heart attack" has occurred.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35861 0
Address 35861 0
Country 35861 0
Phone 35861 0
Fax 35861 0
Email 35861 0
Contact person for public queries
Name 9913 0
Dr Bradley LA FERLITA
Address 9913 0
c/- Department of Anaesthesia
St Vincent's Hospital
Victoria Pde
Fitzroy VIC 3065
Country 9913 0
Australia
Phone 9913 0
+61 3 92882211
Fax 9913 0
+61 3 92884255
Email 9913 0
[email protected]
Contact person for scientific queries
Name 841 0
Dr Bradley LA FERLITA
Address 841 0
c/- Department of Anaesthesia
St Vincent's Hospital
Victoria Pde
Fitzroy VIC 3065
Country 841 0
Australia
Phone 841 0
+61 3 92882211
Fax 841 0
+61 3 92884255
Email 841 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
No additional documents have been identified.