NCT05979038

Clinical Evaluation of the Effect of Metformin in Sepsis

Status unknown Phase 3 Last updated 13 September 2023

What this trial tests

Phase 3 trial testing Metformin in Sepsis in 110 participants. Status unknown.

Timeline

10 September 2023

Primary endpoint
15 June 2024

10 July 2024

Quick facts

Lead sponsor	German University in Cairo
Phase	Phase 3
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	110
Start date	10 September 2023
Primary completion	15 June 2024
Estimated completion	10 July 2024
Sites	1 location across Egypt

Drugs / interventions tested

• Metformin (metformin) — full drug profile →

Conditions studied

• Sepsis — all drugs for Sepsis →

Sponsor

German University in Cairo

Who can join

18 and older, any sex, with Sepsis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Sepsis is defined as life-threatening organ dysfunction caused by a dysregulated host response to infection. It is considered a condition that arises when the body's response to an infection injures its own tissues and organs. The pathogenesis of sepsis is very complicated as it involves imbalance in inflammatory response, immune dysfunction, mitochondrial damage, coagulopathy, neuroendocrine immune network abnormalities, endoplasmic reticulum stress, autophagy, and other pathophysiological processes, and leads to organ dysfunction. Inflammatory Imbalance represents the most critical basis of sepsis pathogenesis. Sepsis is associated with many biochemical abnormalities that is correlated with patients' prognosis and risk of mortality including increased levels of lactate, procalcitonin and inflammatory cytokines as TNF alpha.

Metformin is an oral anti-diabetic drug from the class of biguanides. It is the first line treatment of diabetes type 2. It is widely used as it has good safety profile, low side effect and cheap cost. Metformin has been reported to have an anti-inflammatory and anti-microbial effect.

Some studies have shown that metformin has a beneficial effect in sepsis patients. Our study will be the first prospective controlled randomized trial to assess the clinical outcome of metformin in patients with sepsis.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Mitochondrial dysfunction in sepsis: mechanisms and therapeutic perspectives.
   Hu D, Sheeja Prabhakaran H, Zhang YY, Luo G, et al · · 2024 · cited 69× · PMID 39227925 · DOI 10.1186/s13054-024-05069-w
2. Improving the treatment of bacterial infections caused by multidrug-resistant bacteria through drug repositioning.
   Glajzner P, Bernat A, Jasińska-Stroschein M. · · 2024 · cited 16× · PMID 38910882 · DOI 10.3389/fphar.2024.1397602
3. Sepsis-induced cardiac dysfunction: mitochondria and energy metabolism.
   Yu X, Gao J, Zhang C. · · 2025 · cited 7× · PMID 39966268 · DOI 10.1186/s40635-025-00728-w
4. Immunometabolism, an emerging field in perioperative and critical care medicine: a narrative review.
   Nessel I, Tsang VSK, Schroth J, Janssen H. · · 2026 · cited 1× · PMID 41638974 · DOI 10.1016/j.bja.2026.01.003