Text Size

Preparation of Patients for Cardiac Surgery (MPM)

This study has been completed.
Sponsor:
Collaborator:
Griffith University
Information provided by:
Bayside Health
ClinicalTrials.gov Identifier:
NCT00906646
First received: May 20, 2009
Last updated: NA
Last verified: May 2009
History: No changes posted
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Preparation of Patients for Cardiac Surgery

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Bayside Health:

Primary Outcome Measures:
  • Troponin release [ Time Frame: 24 hours after surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Length of hospital stay [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • Rate of atrial fibrillation [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

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

Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Professor Franklin Rosenfeldt, Alfred Hospital
ClinicalTrials.gov Identifier: NCT00906646     History of Changes
Other Study ID Numbers: 91/04
Study First Received: May 20, 2009
Last Updated: May 20, 2009
Health Authority: Australia: National Health and Medical Research Council

Keywords provided by Bayside Health:
cardiac
surgery
metabolic
supplements
antioxidant

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

ClinicalTrials.gov processed this record on May 21, 2013