Evaluating Metformin's Effect on Sepsis
Evaluation of the Effect of Metformin on the Clinical Outcome of ICU Patients With Sepsis
This study is testing if Metformin, a diabetes medication, can help improve recovery for adults with sepsis.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 110 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | German University in Cairo Academic / other |
| Locations | 1 site (Cairo) |
| Trial ID | NCT05979038 on ClinicalTrials.gov |
What this trial studies
This clinical evaluation investigates the impact of Metformin, an oral anti-diabetic medication, on patients diagnosed with sepsis, a life-threatening condition caused by the body's response to infection. The study aims to assess whether Metformin can improve outcomes in sepsis patients by addressing the inflammatory imbalance and other pathophysiological processes associated with the condition. Eligible participants include adults over 18 years old with a confirmed diagnosis of sepsis and an estimated GFR greater than 45 ml/min. The study will exclude individuals with septic shock, significant comorbidities, or contraindications to Metformin.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old diagnosed with sepsis and having an estimated GFR greater than 45 ml/min.
Not a fit: Patients with septic shock, significant comorbidities, or contraindications to Metformin are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new therapeutic option for improving survival rates and outcomes in sepsis patients.
How similar studies have performed: While the use of Metformin in sepsis is a novel approach, previous studies have explored its anti-inflammatory properties, suggesting potential benefits in similar contexts.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age more than 18 years old. * A diagnosis of sepsis according to the latest Sepsis-3 definition * Estimated GFR \>45 ml/min Exclusion Criteria: * • Immunosuppressed or end stage cancer. * Septic Shock. * Pregnancy and breast feeding. * Patients on metformin, Sodium glucose cotransporters or Gliptins. * End stage hepatic disease. * Contraindications to metformin (chronic respiratory failure, chronic cardiac failure, chronic kidney or liver disease, myocardial infarction within the last month). * Patients with hypersensitivity to metformin.
Where this trial is running
Cairo
- Al Demerdash University Hospital — Cairo, Egypt (Recruiting)
Study contacts
- Study coordinator: Mai M.T Ghannoum, Assistant Lecturer
- Email: mai.tarek@guc.edu.eg
- Phone: 002-01221054807
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.