Recruiting

NCT Number: NCT07300293

Lactic Acidosis and Prior Metformin Treatment

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.

Recruiting

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Key information

Conditions

Type 2 Diabetes Acid-Base Imbalance Acidosis Acidosis, Lactic Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Service de Médecine Intensive - Réanimation - CHU de Strasbourg - France

Strasbourg, 67091, France

Location status: Recruiting

Location contact

Adrien COSTE, MD

SUB_INVESTIGATOR

Vincent CASTELAIN, MD, PhD

CONTACT

[email protected]

33 3.88.12.79.15

Vincent CASTELAIN, MD, PhD

PRINCIPAL_INVESTIGATOR

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Survival rates of patients with severe lactic acidosis admitted to the ICU after prior metformin treatment

Time frame: Up to 18 months

Study contacts

Contact information is provided by the study sponsor or research team.

Vincent CASTELAIN, MD, PhD

CONTACT

[email protected]

33 3.88.12.79.15

Sponsors and collaborators

Lead sponsor

University Hospital, Strasbourg, France

Other

Registry information

Official study title

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

Acronym: MALA

Important dates

Study start: 2024
Primary completion: 2026
Study completion: 2026
First posted: Dec 23, 2025
Registry last updated: Dec 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Recruiting