Recognizing dapagliflozin overdose in ICU patients admitted for metformin poisoning.
Clinical and Biological Signs of Dapagliflozin Overdose in ICU Patients With Metformin Poisoning
This project will see if clinical signs and routine lab tests can help doctors tell whether adults in the ICU for metformin poisoning also took too much dapagliflozin.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier de Saint-Denis Academic / other |
| Locations | 1 site (Saint-Denis, France) |
| Trial ID | NCT07193069 on ClinicalTrials.gov |
What this trial studies
This is an observational comparison of adults admitted to a single ICU for acute metformin poisoning, separating patients exposed to metformin alone from those exposed to both metformin and dapagliflozin. Researchers will review clinical data and standard laboratory results—such as acid-base status, lactate, ketones, glucose, and need for dialysis or vasopressors—collected during ICU care. The team will look for patterns or distinct findings that appear more often when dapagliflozin is involved. Results aim to identify timely clues clinicians can use at the bedside to suspect combined overdose and guide management decisions.
Who should consider this trial
Good fit: Adults aged 18 or older admitted to the ICU for acute drug poisoning with documented exposure to metformin alone or to metformin plus dapagliflozin are eligible.
Not a fit: People who were not exposed to metformin, who took dapagliflozin without metformin, or who are treated outside the ICU are unlikely to benefit from this study's findings.
Why it matters
Potential benefit: If successful, the findings could help clinicians recognize dapagliflozin involvement earlier and tailor treatment to reduce complications and improve outcomes.
How similar studies have performed: There is limited published data specifically on combined metformin and dapagliflozin overdoses, so this is a relatively novel, underreported clinical question.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * Patients under 18 years of age * No exposure to metformin * Exposure to dapagliflozin without metformin
Where this trial is running
Saint-Denis, France
- Centre Hospitalier de Saint-Denis — Saint-Denis, France, France (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.