Preparation of Patients for Cardiac Surgery

Coronary Artery Bypass Graft Surgery Clinical Trial

— MPM  

Official title:

Preparation of Patients for Cardiac Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00906646
• Other study ID #: 91/04
• Status: Completed
• Phase: Phase 3
• First received: May 20, 2009
• Last updated: May 20, 2009
• Start date: April 2004
• Est. completion date: December 2008

Study information

• Verified date: May 2009
• Source: Bayside Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: National Health and Medical Research Council
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 117
• Est. completion date: December 2008
• Est. primary completion date: June 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiac Valve Surgery
• Coronary Artery Bypass Graft Surgery

Intervention

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
Placebo tablets

Locations

Country	Name	City	State
Australia	The Alfred Hospital	Melbourne	Victoria

Sponsors (2)

Lead Sponsor	Collaborator
Bayside Health	Griffith University

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Troponin release		24 hours after surgery	No
Secondary	Length of hospital stay		1 month	No
Secondary	Rate of atrial fibrillation		2 weeks	No