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The metformin in CABG (MetCAB) trial

The metformin in CABG (MetCAB) trial - MetCAB trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON38069
Enrollment
110
Registered
2011-05-03
Start date
2011-11-01
Completion date
Unknown
Last updated
2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

CABG cardiac surgery

Interventions

Pretreatment with metformin (500 mg three times a day for at least 3 days - max 7 days - ) or placebo until the day of surgery

Sponsors

Universitair Medisch Centrum Sint Radboud
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Acceptation for CABG - Informed consent - Age >= 18 years

Exclusion criteria

Exclusion criteria: - Diabetes mellitus - Renal dysfunction (MDRD 3 times upper limit of reference range) - Treatment with dipyridamole or xanthine derivatives - Recent myocardial infarction (

Design outcomes

Primary

MeasureTime frame
High-sensitive troponin-I levels measured before and 6,12 and 24 hours after CABG.

Secondary

MeasureTime frame
Secondary endpoints will include the post-operative occurrence of arrhythmias, the need for inotropic support, time to detubation, and time to discharge from the intensive care unit. Moreover, renal injury and function will be secondary endpoints of the study. Renal ischemia-reperfusion will be assessed by measuring urinary excretion of the markers of tubular damage Kidney Injury Molecule (KIM)-1 and neutrophil gelatinase-associated lipocalin (NGAL), and renal function will be assessed by plasma and urine concentrations of creatinine. Finally, the right auricle will be harvested during surgery to determine whether metformin augments recovery of contractile function of isolated atrial trabeculae after ex vivo simulated ischemia-reperfusion (vide infra) and to determine the effect of metformin on the expression and activation of protein kinases involved in ischemia-reperfusion injury (Western blotting).

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)