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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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
Other interventions - Metabolic therapy
Other interventions - Placebo

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

Placebo Comparator: Placebo - Placebo tablets


Other interventions: 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

Other interventions: Placebo
Placebo tablets
Intervention code [1] 0 0
Other interventions
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
Other
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
This was a prospective randomised trial of metabolic therapy including antioxidants and
cellular energisers to determine whether this therapy could improve the results of cardiac
surgery. The hypothesis was that the metabolic therapy could improve clinical recovery.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00906646
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00906646