Status:
COMPLETED
Study On the Role of Mitochondrial Dysfunction in the Pathogenesis of Metformin-associated Lactic Acidosis
Lead Sponsor:
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Conditions:
Lactic Acidosis
Metformin
Eligibility:
All Genders
18+ years
Brief Summary
Metformin is the first line drug of choice for the treatment of type II diabetes. Lactic acidosis can develop as a side effect, especially when renal failure leads to drug accumulation. Lactic acidosi...
Eligibility Criteria
Inclusion
- Lactic acidosis (pH \< 7.35 or base deficit \> 5 mmol/L and lactate \> 5 mmol/L)
- Metformin intoxication (serum drug level \> 4 mcg/mL)
- Absence of evidence of any other condition that could primarily explain the lactic acidosis
Exclusion
- Less than 18 years of age
- Hemoglobin \< 8 g/dL (10 g/dL if ischemic cardiac disease)
Key Trial Info
Start Date :
January 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 1 2011
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00942123
Start Date
January 1 2009
End Date
October 1 2011
Last Update
September 27 2013
Active Locations (1)
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1
Ospedale Maggiore Policlinico
Milan, MI, Italy, 20122