We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Preparation of Patients for Cardiac Surgery (MPM)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00906646
First Posted: May 21, 2009
Last Update Posted: May 21, 2009
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.
Collaborator:
Griffith University
Information provided by:
Bayside Health
  Purpose
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 Intervention Phase
Coronary Artery Bypass Graft Surgery Cardiac Valve Surgery Dietary Supplement: Metabolic therapy Dietary Supplement: Placebo Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Bayside Health:

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

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

Enrollment: 117
Study Start Date: April 2004
Study Completion Date: December 2008
Primary Completion Date: June 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00906646


Locations
Australia, Victoria
The Alfred Hospital
Melbourne, Victoria, Australia, 3004
Sponsors and Collaborators
Bayside Health
Griffith University
Investigators
Study Director: Franklin L Rosenfeldt, MBBS, MD The Alfred
  More Information

Responsible Party: Professor Franklin Rosenfeldt, Alfred Hospital
ClinicalTrials.gov Identifier: NCT00906646     History of Changes
Other Study ID Numbers: 91/04
First Submitted: May 20, 2009
First Posted: May 21, 2009
Last Update Posted: May 21, 2009
Last Verified: May 2009

Keywords provided by Bayside Health:
cardiac
surgery
metabolic
supplements
antioxidant

Additional relevant MeSH terms:
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs