Lactic Acidosis and Prior Metformin Treatment (MALA)

December 9, 2025 updated by: University Hospital, Strasbourg, France

Prognosis of Lactic Acidosis Upon Admission to Intensive Care According to the Existence of Prior Treatment With Metformin

Metformin is a drug frequently prescribed to patients with type 2 diabetes. Furthermore, diabetes can lead to micro- and macrovascular complications that may cause chronic organ failure. The presence of diabetes also increases the risk of infections. All of these factors contribute to the frequent admission of patients to the ICU who have been receiving metformin treatment in the preceding days. Acute renal failure, which is also frequently observed upon admission to the ICU, increases the risk of metformin overdose. In cases of overdose, metformin acts on several metabolic pathways that can lead to or even accelerate metabolic acidosis, sometimes severe. However, the impact on prognosis is controversial.

The role of metformin in lactic acidosis in patients treated for acute illness may be underestimated in routine practice.

This study aims to investigate the impact of prior metformin treatment on ICU survival in patients admitted to the ICU with severe lactic acidosis.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

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

Study Contact

Study Locations

  • France
      • Strasbourg, France, 67091
        • Recruiting
        • Service de Médecine Intensive - Réanimation - CHU de Strasbourg - France
        • Principal Investigator:
          • Vincent CASTELAIN, MD, PhD
        • Contact:
        • Sub-Investigator:
          • Adrien COSTE, MD

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Adult patient (≥18 years) having experienced lactic acidosis (pH <7.35 and lactate level ≥5 mmol/L) within the first 24 hours of hospitalization.

Description

Inclusion Criteria:

  • Adult patient (≥18 years)
  • Admitted to the intensive care unit of Hautepierre Hospital - Strasbourg University Hospital between January 1, 2014, and December 31, 2023
  • Having experienced lactic acidosis (pH <7.35 and lactate level ≥5 mmol/L) within the first 24 hours of hospitalization.

Exclusion Criteria:

  • Patient without arterial blood gas measurements during the first 24 hours of admission
  • whose background treatment is unknown and could not be determined
  • for whom a limitation of active therapies was implemented before or during the first 24 hours of hospitalization

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Survival rates of patients with severe lactic acidosis admitted to the ICU after prior metformin treatment
Time Frame: Up to 18 months
Up to 18 months

Collaborators and Investigators

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

Sponsor

University Hospital, Strasbourg, France

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 (Actual)

November 6, 2024

Primary Completion (Estimated)

May 1, 2026

Study Completion (Estimated)

May 1, 2026

Study Registration Dates

First Submitted

December 9, 2025

First Submitted That Met QC Criteria

December 9, 2025

First Posted (Actual)

December 23, 2025

Study Record Updates

Last Update Posted (Actual)

December 23, 2025

Last Update Submitted That Met QC Criteria

December 9, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 9381 (Fred Hutch/University of Washington Cancer Consortium)

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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