Study of Metformin Overdose

NCT04762966 | Unknown

• 1 other identifier: 2021PI020
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Metformin Associated Lactic Acidosis

Keywords

Metformin; Lactic Acidosis; Causality assessment

Outcome Measures

Primary Outcomes (1)

• Estimation of Mortality Rate

  2 years

Secondary Outcomes (2)

• Estimation of Hospitalization Rate

  2 years

• Identification of Risk Factors

  2 years

Study Arms (2)

Therapeutic

Patients with metformin blood concentration in the therapeutic ranges.

Drug: Metformin

Supratherapeutic

Patients with metformin blood concentration above the therapeutic ranges.

Drug: Metformin

Interventions

Metformin DRUG

Level of Metformin blood concentration

Supratherapeutic; Therapeutic

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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 and hospitalized in the university hospital of Nancy.

You may qualify if:

• 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.

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

Study Sites (1)

University Hospital of Nancy

Vandœuvre-lès-Nancy, 54000, France

RECRUITING

Related 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):e235608. doi: 10.1136/bcr-2020-235608.

  PMID: 32878828 BACKGROUND

• Walz L, Jonsson AK, Ahlner J, Ostgren 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.

  PMID: 31491622 BACKGROUND

• 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.

  PMID: 30967322 BACKGROUND

MeSH Terms

Conditions

Acidosis, Lactic

Interventions

Metformin

Condition Hierarchy (Ancestors)

Acidosis; Acid-Base Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr Julien SCALA-BERTOLA

Study Record Dates

• First Submitted: February 17, 2021
• First Posted: February 21, 2021
• Study Start: March 1, 2021
• Primary Completion: August 1, 2021
• Study Completion: September 1, 2021
• Last Updated: February 21, 2021

Record last verified: 2021-02

Locations

FR (1)