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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00906646




Registration number
NCT00906646
Ethics application status
Date submitted
20/05/2009
Date registered
21/05/2009
Date last updated
21/05/2009

Titles & IDs
Public title
Preparation of Patients for Cardiac Surgery
Scientific title
Preparation of Patients for Cardiac Surgery
Secondary ID [1] 0 0
91/04
Universal Trial Number (UTN)
Trial acronym
MPM
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Coronary Artery Bypass Graft Surgery 0 0
Cardiac Valve Surgery 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Metabolic therapy
Treatment: Other - Placebo

Experimental: Metabolic therapy - Metabolic therapy with antioxidants and cellular energisers

Placebo comparator: Placebo - Placebo tablets


Treatment: Other: Metabolic therapy
Coenzyme Q10 - 100 mg tds Magnesium orotate - 400 mg tds Lipoic acid - 100 mg tds Omega-3 fatty acids - 300 mg (in 1 g fish oils) tds Selenium - 200 µg

Treatment: Other: Placebo
Placebo tablets
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Troponin release
Timepoint [1] 0 0
24 hours after surgery
Secondary outcome [1] 0 0
Length of hospital stay
Timepoint [1] 0 0
1 month
Secondary outcome [2] 0 0
Rate of atrial fibrillation
Timepoint [2] 0 0
2 weeks

Eligibility
Key inclusion criteria
* patients undergoing elective coronary artery bypass graft (CABG) and/or valve surgery
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* urgent or emergency surgery
* NYHA class IV heart failure
* taken antioxidant supplements in the previous month

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering 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

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/04/2004
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2008
Sample size
Target
Accrual to date
Final
117
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
The Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Government body
Name
Bayside Health
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Griffith University
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Franklin L Rosenfeldt, MBBS, MD
Address 0 0
The Alfred
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

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

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00906646