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Preparation of Patients for Cardiac Surgery

Preparation of Patients for Cardiac Surgery

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00906646
Acronym
MPM
Enrollment
117
Registered
2009-05-21
Start date
2004-04-30
Completion date
2008-12-31
Last updated
2009-05-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Valve Surgery, Coronary Artery Bypass Graft Surgery

Keywords

cardiac, surgery, metabolic, supplements, antioxidant

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.

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.

Interventions

DIETARY_SUPPLEMENTMetabolic 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

DIETARY_SUPPLEMENTPlacebo

Placebo tablets

Sponsors

Griffith University
CollaboratorOTHER
Bayside Health
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
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

Design outcomes

Primary

MeasureTime frame
Troponin release24 hours after surgery

Secondary

MeasureTime frame
Length of hospital stay1 month
Rate of atrial fibrillation2 weeks

Countries

Australia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026