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Preparation of Patients for Cardiac Surgery (MPM)

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 evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00906646
Recruitment Status : Completed
First Posted : May 21, 2009
Last Update Posted : May 21, 2009
Griffith University
Information provided by:
Bayside Health

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.

Condition or disease Intervention/treatment Phase
Coronary Artery Bypass Graft Surgery Cardiac Valve Surgery Dietary Supplement: Metabolic therapy Dietary Supplement: Placebo Phase 3

Detailed Description:

Objective Perioperative therapy with antioxidants and metabolic substrates has the potential to reduce oxidative stress and improve recovery from cardiac surgery, particularly in elderly and high risk cases. The aim of the study was to assess the effect of perioperative metabolic therapy at a biochemical and clinical level in cardiac surgical patients.

Methods Patients (n = 117, mean age 65 ± 1.0 years, 74% male) undergoing elective coronary artery bypass graft (CABG) and/or valve surgery were randomized to receive for a minimum of 2 weeks before and one month after surgery, either metabolic therapy (coenzyme Q10, magnesium orotate, lipoic acid, omega-3 fatty acids and selenium) or placebo. Biochemical and clinical outcomes were assessed.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 117 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Preparation of Patients for Cardiac Surgery
Study Start Date : April 2004
Actual Primary Completion Date : June 2006
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery

Arm Intervention/treatment
Experimental: Metabolic therapy
Metabolic therapy with antioxidants and cellular energisers
Dietary Supplement: 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

Placebo Comparator: Placebo
Placebo tablets
Dietary Supplement: Placebo
Placebo tablets

Primary Outcome Measures :
  1. Troponin release [ Time Frame: 24 hours after surgery ]

Secondary Outcome Measures :
  1. Length of hospital stay [ Time Frame: 1 month ]
  2. Rate of atrial fibrillation [ Time Frame: 2 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • patients undergoing elective coronary artery bypass graft (CABG) and/or valve surgery

Exclusion Criteria:

  • urgent or emergency surgery
  • NYHA class IV heart failure
  • taken antioxidant supplements in the previous month

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00906646

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Australia, Victoria
The Alfred Hospital
Melbourne, Victoria, Australia, 3004
Sponsors and Collaborators
Bayside Health
Griffith University
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Study Director: Franklin L Rosenfeldt, MBBS, MD The Alfred
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Responsible Party: Professor Franklin Rosenfeldt, Alfred Hospital Identifier: NCT00906646    
Other Study ID Numbers: 91/04
First Posted: May 21, 2009    Key Record Dates
Last Update Posted: May 21, 2009
Last Verified: May 2009
Keywords provided by Bayside Health: