Coronary Artery Bypass Graft SurgeryPhase 3MPMNCT00906646
Preparation of Patients for Cardiac Surgery
A Phase 3 study testing Metabolic therapy in people with Coronary Artery Bypass Graft Surgery and Cardiac Valve Surgery, run by Bayside Health at 1 site in Australia.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Coronary Artery Bypass Graft Surgery, Cardiac Valve Surgery
- What is being tested?
- Metabolic therapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 117 participants
- Where
- 1 siteAustralia
- Study dates
- Apr 2004to Dec 2008
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- patients undergoing elective coronary artery bypass graft (CABG) and/or valve surgery
Who cannot join
- urgent or emergency surgery
- NYHA class IV heart failure
- taken antioxidant supplements in the previous month
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Being tested
- Metabolic therapy, Placebo
- Keywords
- cardiac, surgery, metabolic, supplements, antioxidant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
PlaceboDietary supplement
Placebo tablets
| Study group | Role | What they receive |
|---|---|---|
| Metabolic therapy | Experimental | Metabolic therapy with antioxidants and cellular energisers Receives: Dietary Supplement: Metabolic therapy |
| Placebo | Placebo comparator | Placebo tablets Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Troponin release
Measured: 24 hours after surgery
Secondary outcomes (2)
Length of hospital stay
Measured: 1 month
Rate of atrial fibrillation
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2009 (estimated)
- Study startApr 2004
- Primary completionJun 2006
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery Bypass Graft SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayside Health
- Sponsor type
- Other government
- Collaborators
- Griffith University
- Investigators
- Franklin L Rosenfeldt, MBBS, MD, Study director, The Alfred
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00906646
- Sponsor's protocol ID
- 91/04
- Acronym
- MPM
- Status last verified
- May 2009
- First submitted
- 20 May 2009
- Last updated
- 21 May 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preparation of Patients for Cardiac Surgery
- ClinicalTrials.gov ID
- NCT00906646
- Acronym / sponsor ID
- MPM / 91/04
- Keywords
- cardiac, surgery, metabolic, supplements, antioxidant
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 117 participants (actual)
- Lead sponsor
- Bayside HealthOther government
- Collaborators
- Griffith University
- Study start
- Apr 2004
- Primary completion
- Jun 2006 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 21 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Metabolic therapy | Experimental | Dietary Supplement: Metabolic therapyMetabolic therapy with antioxidants and cellular energisers |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo tablets |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- patients undergoing elective coronary artery bypass graft (CABG) and/or valve surgery
Key exclusion criteria (3 listed)
- urgent or emergency surgery
- NYHA class IV heart failure
- taken antioxidant supplements in the previous month
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Metabolic therapyCoenzyme 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 supplement | Metabolic therapy |
| PlaceboPlacebo tablets | Dietary supplement | Placebo |
Primary outcome
Troponin release
Time frame: 24 hours after surgery
2 secondary outcomes
Length of hospital stay
Time frame: 1 month
Rate of atrial fibrillation
Time frame: 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2009.
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Preoperative Gastric Ultrasound and Left Ventricular Function in Coronary Artery Bypass Surgery
Coronary Artery Disease, Left Ventricular Systolic Dysfunction
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Investigation of the Effects of Respiratory Muscle Training Combined With Otago Exercises in Elderly Patients Undergoing Coronary Artery Bypass Graft Surgery
Coronary Artery Bypass Graft (CABG)
Recruiting
Postural Mobilization Compared to Noradrenaline Only in Off-Pump CABG Surgery
Coronary Artery Disease With Need for Bypass Surgery, Coronary Artery Disease(CAD)
Active, not recruitingPhase 1
Comparison of Analgesic Efficacy Between Ultrasound Guided Serratus Anterior Plane Block or Thoracic Paravertebral Block Versus Intravenous Fentanyl for On-pump Coronary Artery Bypass Graft Surgery
Intra and Post Operative Pain Management, Fast Track Program,(Enhanced Recovery After Surgery (ERAS))
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Franklin L Rosenfeldt, MBBS, MD study director
The Alfred
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Metabolic therapy in people with Coronary Artery Bypass Graft Surgery and Cardiac Valve Surgery, run by Bayside Health at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 May 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Troponin release (time frame: 24 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2009.