Clinical Evaluation of the Effect of Metformin in Sepsis

NCT05979038 | Unknown Phase 3

• 1 other identifier: FMASU MD146/2023
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief 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

Sepsis

Outcome Measures

Primary Outcomes (1)

• 28 days mortality

  Patients mortality rate and time from ICU admission till death due to any cause will be assessed within 28 days even after discharge from the ICU.

  28 days

Secondary Outcomes (12)

• 2.Total ICU lengths of stay:

  28 days

• 3.Arterial blood gases (ABG):

  28 days

• 4- Serum TNF alpha:

  28 days

• 5- Total Leucocytic Count (TLC):

  28 days

• 6- Sequential organ Failure assessment Scores (SOFA):

  28 days

Study Arms (2)

Metformin arm

EXPERIMENTAL

In this arm patients will administrate metformin 500 mg three times a day together with the standard care of sepsis.

Drug: Metformin

Control Arm

NO INTERVENTION

In this arm patients will receive the standard care of sepsis only

Interventions

Metformin DRUG

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

Also known as: Glucophage

Metformin arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age more than 18 years old.
• A diagnosis of sepsis according to the latest Sepsis-3 definition
• Estimated GFR \>45 ml/min

You may not qualify if:

• 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.

Sponsors & Collaborators

• German University in Cairo: lead

Study Sites (1)

Al Demerdash University Hospital

Cairo, Egypt

RECRUITING

MeSH Terms

Conditions

Sepsis

Interventions

Metformin

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Central Study Contacts

Mai M.T Ghannoum, Assistant Lecturer

CONTACT

002-01221054807; mai.tarek@guc.edu.eg

Mohamed H. Solayman, Lecturer

CONTACT

002-01005882550; mohamed.solayman@guc.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer of Clinical Pharmacy

Study Record Dates

• First Submitted: July 30, 2023
• First Posted: August 7, 2023
• Study Start: September 10, 2023
• Primary Completion: June 15, 2024
• Study Completion: July 10, 2024
• Last Updated: September 13, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)