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Recruiting NCT07193069

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

— Observational Drug Overdose Metformin Dapagliflozin Lactic Acidosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Drug Overdose, Metformin, Dapagliflozin, Lactic Acidosis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Primary outcome measures

  • Identification of clinical and biological differences between patients admitted to intensive care for metformin overdose alone versus those with combined metformin and dapagliflozin overdose. [Time frame: 10 years]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Cohort

Study locations

France · 1 center
  • Centre Hospitalier de Saint-Denis — Saint-Denis

Identifiers

NCT: NCT07193069 · 0109_REANIMATION_INTEND

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗