Actively Recruiting
Clinical and Biological Signs of Dapagliflozin Overdose in ICU Patients With Metformin Poisoning
Led by Centre Hospitalier de Saint-Denis · Updated on 2025-09-25
50
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying patients admitted to intensive care units due to drug poisoning involving metformin, a medication commonly used for diabetes. The study compares two groups: those who overdosed on metformin alone and those who overdosed on both metformin and dapagliflozin, another diabetes drug. The goal is to find clinical or biological signs that can help doctors quickly identify an overdose involving dapagliflozin in these patients, which may improve treatment decisions and patient outcomes. This observational study monitors patients admitted for metformin poisoning with or without dapagliflozin. No specific treatments are given as part of the study; instead, researchers collect clinical and laboratory data from these patients over a period of up to 10 years. The study focuses on identifying differences in clinical presentation and biological markers between the two groups. Participants will be evaluated during their ICU stay with clinical assessments and laboratory tests as part of their usual care. Researchers will analyze these data to identify distinguishing features between the overdose types. The primary outcome measure is the identification of clinical and biological differences between patients who overdosed on metformin alone versus those with combined metformin and dapagliflozin overdose over a 10-year observation period. The study started in April 2025 and will continue until April 2026.
CONDITIONS
Brief Title
Clinical and Biological Signs of Dapagliflozin Overdose in ICU Patients With Metformin Poisoning
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Admission to an intensive care unit (ICU) due to acute drug poisoning
- Documented exposure to metformin alone or metformin combined with dapagliflozin
You will not qualify if you...
- Patients under 18 years of age
- No exposure to metformin
- Exposure to dapagliflozin without metformin
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 10 years
Participants who are admitted to intensive care due to drug poisoning are observed to identify clinical and biological differences related to metformin and dapagliflozin exposure.
Visits as part of standard intensive care and follow-up
Trial Site Locations
Total: 1 location
1
Centre Hospitalier de Saint-Denis
Saint-Denis, France, France
Actively Recruiting
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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