Study of Metformin Overdose (METINFO)

February 18, 2021 updated by: SCALA-BERTOLA Julien, Central Hospital, Nancy, France

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Vandoeuvre-les-nancy, France, 54000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Estimation of Mortality Rate
Time Frame: 2 years
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Estimation of Hospitalization Rate
Time Frame: 2 years
2 years
Identification of Risk Factors
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Central Hospital, Nancy, France

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 1, 2021

Primary Completion (Anticipated)

August 1, 2021

Study Completion (Anticipated)

September 1, 2021

Study Registration Dates

First Submitted

February 17, 2021

First Submitted That Met QC Criteria

February 18, 2021

First Posted (Actual)

February 21, 2021

Study Record Updates

Last Update Posted (Actual)

February 21, 2021

Last Update Submitted That Met QC Criteria

February 18, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021PI020

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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