Using Metformin and Lactoferrin to Treat Sepsis in ICU Patients
Comparative Study to Evaluate the Safety and Possible Efficacy of Metformin Versus Lactoferrin in ICU Patients With
This study is testing if the combination of metformin and lactoferrin can help improve the treatment of sepsis in adult patients in the ICU.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Tanta University Academic / other |
| Locations | 1 site (Tanta) |
| Trial ID | NCT06181422 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the safety and efficacy of metformin and lactoferrin in patients diagnosed with sepsis in the intensive care unit (ICU). Sepsis is a severe condition characterized by organ dysfunction due to an uncontrolled response to infection, leading to high mortality rates. The study will involve adult patients over 18 years old with a confirmed diagnosis of sepsis and an estimated glomerular filtration rate (GFR) greater than 45 ml/min. By comparing these two interventions, the research seeks to identify potential benefits in managing sepsis effectively.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old who have been diagnosed with sepsis and have a sufficient kidney function.
Not a fit: Patients who are pregnant, breastfeeding, or have end-stage liver or kidney disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide new treatment options that improve survival rates and outcomes for patients with sepsis.
How similar studies have performed: Previous studies have indicated that metformin may reduce mortality in septic patients, suggesting that this approach could be promising.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Inclusion Criteria: 1. Age more than 18 years old. 2. A diagnosis of sepsis according to the latest Sepsis definition.11 3. Estimated GFR \>45 ml/minute. Exclusion Criteria: Exclusion Criteria: 1. Pregnancy and breast feeding. 2. End stage hepatic disease. 3. End stage renal disease -
Where this trial is running
Tanta
- Tanta — Tanta, Egypt (Recruiting)
Study contacts
- Principal investigator: Alaa Hemida — Tanta University
- Study coordinator: Alaa Hemida
- Email: Alaa.hemida@pharm.tanta.efu.eg
- Phone: 667867
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.