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Clinical Evaluation of the Effect of Metformin in Sepsis

NCT05979038 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2023-09-13

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Metformin

Patients in the intervention arm will take metformin 500mg three times a day

Sponsors & Collaborators

  • German University in Cairo

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-10
Primary Completion
2024-06-15
Completion
2024-07-10

Countries

  • Egypt

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05979038 on ClinicalTrials.gov