Preparation of Patients for Cardiac Surgery

Phase 3

Completed

• Conditions: Coronary Artery Bypass Graft Surgery; Cardiac Valve Surgery
• Interventions: Dietary Supplement: Metabolic therapy; Dietary Supplement: Placebo

• Registration Number: NCT00906646
• Lead Sponsor: Bayside Health

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.

Study Timeline

• Study Start: 2004-04
• Primary Completion: 2006-06
• Study Completion: 2008-12
• Status Verified: 2009-05
• Study First Submitted: 2009-05-20
• Study First Submitted QC: 2009-05-20
• Last Update Submitted: 2009-05-20
• Study First Posted: 2009-05-21
• Last Update Posted: 2009-05-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 117

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Metabolic therapy	Metabolic therapy	Metabolic therapy with antioxidants and cellular energisers
Placebo	Placebo	Placebo tablets

Primary Outcome Measures

Name	Time	Method
Troponin release	24 hours after surgery

Secondary Outcome Measures

Name	Time	Method
Length of hospital stay	1 month
Rate of atrial fibrillation	2 weeks

Trial Locations

Locations (1)

The Alfred Hospital; 🇦🇺 Melbourne, Victoria, Australia