METINFO: Study of Metformin Overdose

• Sponsor: Central Hospital, Nancy, France (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04762966
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Anticipated Duration (Months): 6
• Patients Per Site Per Month: 8.3

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Metformin Associated Lactic Acidosis	Drug: Metformin

Study Design

• Study Type: Observational
• Anticipated Enrollment: 50 participants
• Observational Model: Case-Control
• Time Perspective: Retrospective
• Official Title: Study of Metformin Overdose in Adult Patients Treated at the University Hospital of Nancy: Single-center Descriptive Retrospective Observational Study
• Anticipated Study Start Date: Mar 1, 2021
• Anticipated Primary Completion Date: Aug 1, 2021
• Anticipated Study Completion Date: Sep 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Therapeutic Patients with metformin blood concentration in the therapeutic ranges.	Drug: Metformin; Level of Metformin blood concentration
Supratherapeutic Patients with metformin blood concentration above the therapeutic ranges.	Drug: Metformin; Level of Metformin blood concentration

Outcome Measures

Primary Outcome Measures

1. Estimation of Mortality Rate [2 years]

Secondary Outcome Measures

1. Estimation of Hospitalization Rate [2 years]

2. Identification of Risk Factors [2 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital of Nancy	Vandoeuvre-les-nancy		France	54000

Sponsors and Collaborators

• Central Hospital, Nancy, France

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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. Corrected and republished in: Drug Ther Bull. 2021 Aug;59(8):124-127.
• 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.
• 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.

• Responsible Party: SCALA-BERTOLA Julien, Dr Julien SCALA-BERTOLA, Central Hospital, Nancy, France
• ClinicalTrials.gov Identifier: NCT04762966
• Other Study ID Numbers: 2021PI020
• First Posted: Feb 21, 2021
• Last Update Posted: Feb 21, 2021
• Last Verified: Feb 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by SCALA-BERTOLA Julien, Dr Julien SCALA-BERTOLA, Central Hospital, Nancy, France: Metformin; Lactic Acidosis; Causality assessment
• Additional relevant MeSH terms: Acidosis; Acidosis, Lactic; Metformin

Study Results

No Results Posted as of Feb 21, 2021