Metformin and Lactoferrin in Sepsis in Icu

Sepsis Clinical Trial

Official title:

Comparative Study to Evaluate the Safety and Possible Efficacy of Metformin Versus Lactoferrin in ICU Patients With

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06181422
• Other study ID #: metformin and lactoferrin
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: April 2024
• Est. completion date: June 9, 2024

Study information

• Verified date: April 2024
• Source: Tanta University
• Contact: Alaa Hemida
• Phone: 667867
• Email: Alaa.hemida[@]pharm.tanta.efu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Sepsis is a life-threatening organ dysfunction triggered by an unregulated response of a host to infection. Sepsis is a reason for substantial mortality and morbidity among intensive care unit (ICU) patients. 1 Therefore, the aim of our study is to compare the safety and efficacy of metformin and lactoferrin in ICU patients with sepsis.

Description:

Sepsis is a life-threatening organ dysfunction triggered by an unregulated response of a host to infection. Sepsis is a reason for substantial mortality and morbidity among intensive care unit (ICU) patients. 1 The pathophysiology of sepsis has changed spectacularly over the last several decades. Significant comprehension into the components of the inflammatory response has been achieved. Inflammation contributes to endothelial injury and initiates coagulation pathways.2 The inflammatory reaction is mediated by the release of cytokines (tumor necrosis factor-alpha, interleukins, and prostaglandins) from neutrophils and macrophages. The cytokines trigger the extrinsic coagulation cascade and inhibit fibrinolysis. These overlapping processes end with organ dysfunction.3 The Sequential Organ Failure Assessment or SOFA score was developed to assess the acute morbidity of critical illness at a population level and has been extensively validated as a tool for this purpose across a range of healthcare settings and environments.4 Metformin is oral anti-diabetic agent that has positive effects such as antioxidant and anti-inflammatory properties which are considered potentially beneficial properties for management of septic patients. Previous studies showed that preadmission metformin use may reduce mortality in adult patients with sepsis and diabetes mellitus. Therefore, our study aims to test the potential efficacy of metformin in all subsets of patient with sepsis.5,6 Lactoferrin is a cationic glycoprotein and associated with many activities including the relevant anti-inflammatory one, especially associated to the downregulation of pro-inflammatory cytokines besides its anti-microbial and immunomodulatory effect.7 A previous study suggested that lactoferrin supplementation to enteral feeds with or without probiotics decreases late-onset sepsis in preterm infants without adverse effects and this encourage us to test its role in adult patients with sepsis.8 Therefore, the aim of our study is to compare the safety and efficacy of metformin and lactoferrin in ICU patients with sepsis.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 9, 2024
• Est. primary completion date: June 9, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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 -

Related Conditions & MeSH terms

• Sepsis

Intervention

Drug:
• Metformin
metformin 500 mg
• Lactoferrin
lactoferrin 100 mg

Locations

Country	Name	City	State
Egypt	Tanta	Tanta

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary endpoint is mortality rate		28 days