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Completed

NCT Number: NCT00906646

Preparation of Patients for Cardiac Surgery

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.

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Key information

Conditions

Coronary Artery Bypass Graft Surgery Cardiac Valve Surgery

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

The Alfred Hospital

Melbourne, Victoria, 3004, Australia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Metabolic therapy

Dietary Supplement

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

Dietary Supplement

Placebo tablets

Primary outcomes

  1. Troponin release

    Time frame: 24 hours after surgery

Secondary outcomes

  1. Length of hospital stay

    Time frame: 1 month

  2. Rate of atrial fibrillation

    Time frame: 2 weeks

Sponsors and collaborators

Lead sponsor

Bayside Health

Other Gov

Collaborators

  • Griffith University

Registry information

Acronym: MPM

Important dates

Study start
2004
Primary completion
2006
Study completion
2008
First posted
May 21, 2009
Registry last updated
May 21, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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