Study of Metformin Overdose

Metformin Associated Lactic Acidosis Clinical Trial

— METINFO  

Official title:

Study of Metformin Overdose in Adult Patients Treated at the University Hospital of Nancy: Single-center Descriptive Retrospective Observational Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04762966
• Other study ID #: 2021PI020
• Status: Recruiting
• Start date: March 1, 2021
• Est. completion date: September 1, 2021

Study information

• Verified date: February 2021
• Source: Central Hospital, Nancy, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The objective of the METINFO study is an observational single-center retrospective and descriptive study. The main objective is to estimate the real mortality rate associated to a Metformin overdose. Second objectives are to estimate the real hospitalization rate related to metformin overdose and to identify the risk factors of a metformin overdose and especially the potential correlation between metformin blood concentration and overdose severity.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: September 1, 2021
• Est. primary completion date: August 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult patients benifiting of a metformin blood concentration determination in the period ranging from the 1st of July 2019 and the 1st of July 2021.

Exclusion Criteria: None.

Related Conditions & MeSH terms

• Acidosis
• Acidosis, Lactic
• Metformin Associated Lactic Acidosis

Intervention

Drug:
• Metformin
Level of Metformin blood concentration

Locations

Country	Name	City	State
France	University Hospital of Nancy	Vandoeuvre-les-nancy

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

References & Publications (3)

Goonoo MS, Morris R, Raithatha A, Creagh F. Metformin-associated lactic acidosis: reinforcing learning points. BMJ Case Rep. 2020 Sep 2;13(9). pii: e235608. doi: 10.1136/bcr-2020-235608. — View Citation

Taub ES, Hoffman RS, Manini AF. Incidence and risk factors for hyperlactatemia in ED patients with acute metformin overdose. Am J Emerg Med. 2019 Dec;37(12):2205-2208. doi: 10.1016/j.ajem.2019.03.033. Epub 2019 Mar 23. — View Citation

Walz L, Jönsson AK, Ahlner J, Östgren CJ, Druid H. Metformin - Postmortem fatal and non-fatal reference concentrations in femoral blood and risk factors associated with fatal intoxications. Forensic Sci Int. 2019 Oct;303:109935. doi: 10.1016/j.forsciint.2019.109935. Epub 2019 Aug 28. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Estimation of Mortality Rate		2 years
Secondary	Estimation of Hospitalization Rate		2 years
Secondary	Identification of Risk Factors		2 years