Preparation of Patients for Cardiac Surgery (MPM)

Bayside Health

Status and phase: Completed; Phase 3

Conditions: Coronary Artery Bypass Graft Surgery; Cardiac Valve Surgery

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Metabolic therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT00906646

91/04

Details and patient eligibility

About

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.

Full 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.

Enrollment: 117 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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117 participants in 2 patient groups, including a placebo group

Metabolic therapy

Experimental group

Description:

Metabolic therapy with antioxidants and cellular energisers

Treatment:

Dietary Supplement: Metabolic therapy

Placebo

Placebo Comparator group

Description:

Placebo tablets

Treatment:

Dietary Supplement: Placebo