Clinical and Biological Signs of Dapagliflozin Overdose in ICU Patients With Metformin Poisoning

NCT07193069 | Recruiting

• 1 other identifier: 0109_REANIMATION_INTEND
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This study looks at patients admitted to intensive care for drug poisoning involving metformin, a common diabetes medication. Researchers will compare two groups: patients who overdosed on metformin alone and those who took both metformin and dapagliflozin, another diabetes drug. The goal is to find clinical or laboratory signs that could help doctors quickly recognize a dapagliflozin overdose in this context, which could improve treatment and patient outcomes.

Conditions

Drug Overdose; Metformin; Dapagliflozin; Lactic Acidosis; Diabetic Ketoacidosis; Intensive Care Units

Outcome Measures

Primary Outcomes (1)

• Identification of clinical and biological differences between patients admitted to intensive care for metformin overdose alone versus those with combined metformin and dapagliflozin overdose.

  10 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will consist of adult patients (aged 18 years and older) who were admitted to intensive care units across multiple centers for acute drug poisoning involving metformin, with or without dapagliflozin. Participants will be identified retrospectively through case collection from the SRLF (Société de Réanimation de Langue Française) and existing hospital records over the past 10 years. The study will include both cases of isolated metformin overdose and cases of combined metformin and dapagliflozin overdose.

You may qualify if:

• Adults aged 18 years or older
• Admission to an intensive care unit (ICU) due to acute drug poisoning
• Documented exposure to either:
• Metformin alone
• Metformin in combination with dapagliflozin

You may not qualify if:

• Patients under 18 years of age
• No exposure to metformin
• Exposure to dapagliflozin without metformin

Sponsors & Collaborators

• Centre Hospitalier de Saint-Denis: lead

Study Sites (1)

Centre Hospitalier de Saint-Denis

Saint-Denis, France, France

RECRUITING

MeSH Terms

Conditions

Drug Overdose; Acidosis, Lactic; Diabetic Ketoacidosis

Condition Hierarchy (Ancestors)

Prescription Drug Misuse; Drug Misuse; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Acidosis; Acid-Base Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases; Ketosis; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Study Design

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

Study Record Dates

• First Submitted: June 30, 2025
• First Posted: September 25, 2025
• Study Start: April 11, 2025
• Primary Completion: April 11, 2026
• Study Completion: April 11, 2026
• Last Updated: September 25, 2025

Record last verified: 2025-06

Locations

FR (1)