NCT00906646

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
117

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Apr 2004

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2004

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2006

Completed
2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

May 20, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 21, 2009

Completed
Last Updated

May 21, 2009

Status Verified

May 1, 2009

Enrollment Period

2.2 years

First QC Date

May 20, 2009

Last Update Submit

May 20, 2009

Conditions

Coronary Artery Bypass Graft SurgeryCardiac Valve Surgery

Keywords

cardiacsurgerymetabolicsupplementsantioxidant

Outcome Measures

Primary Outcomes (1)

  • Troponin release

    24 hours after surgery

Secondary Outcomes (2)

  • Length of hospital stay

    1 month

  • Rate of atrial fibrillation

    2 weeks

Study Arms (2)

Metabolic therapy

EXPERIMENTAL

Metabolic therapy with antioxidants and cellular energisers

Dietary Supplement: Metabolic therapy

Placebo

PLACEBO COMPARATOR

Placebo tablets

Dietary Supplement: Placebo

Interventions

Metabolic therapyDIETARY_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

Metabolic therapy
PlaceboDIETARY_SUPPLEMENT

Placebo tablets

Placebo

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • patients undergoing elective coronary artery bypass graft (CABG) and/or valve surgery

You may not qualify if:

  • urgent or emergency surgery
  • NYHA class IV heart failure
  • taken antioxidant supplements in the previous month

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Alfred Hospital

Melbourne, Victoria, 3004, Australia

Location

Study Officials

  • Franklin L Rosenfeldt, MBBS, MD

    The Alfred

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

May 20, 2009

First Posted

May 21, 2009

Study Start

April 1, 2004

Primary Completion

June 1, 2006

Study Completion

December 1, 2008

Last Updated

May 21, 2009

Record last verified: 2009-05

Locations

AU(1)