Lactic Acidosis and Prior Metformin Treatment

NCT07300293 | Recruiting

• 1 other identifier: 9381
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Type 2 Diabetes

Keywords

Type 2 diabetes; Metformin Treatment; Lactic acidosis; Metabolic acidosis

Outcome Measures

Primary Outcomes (1)

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

  Up to 18 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (1)

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

Strasbourg, 67091, France

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Acidosis, Lactic; Acidosis

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Acid-Base Imbalance

Central Study Contacts

Vincent CASTELAIN, MD, PhD

CONTACT

33 3.88.12.79.15; vincent.castelain@chru-strasbourg.fr

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2025
• First Posted: December 23, 2025
• Study Start: November 6, 2024
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: December 23, 2025

Record last verified: 2025-12

Locations

FR (1)