Metformin and Lactoferrin in Sepsis in Icu

NCT ID: NCT06181422

Last Updated: 2024-04-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-30
• Study Completion Date: 2024-06-09

Brief 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.

Detailed 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.

Conditions

Sepsis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Group1: Metformin

Group1: (Metformin, n=30) who will receive metformin 500 mg three times daily.

Group Type: ACTIVE_COMPARATOR

Metformin

Intervention Type: DRUG

metformin 500 mg

Group 2 :Lactoferrin

Group 2 :(Lactoferrin, n=30) who will receive lactoferrin 100 mg three times daily

Group Type: ACTIVE_COMPARATOR

Lactoferrin

Intervention Type: DRUG

lactoferrin 100 mg

Interventions

Metformin

metformin 500 mg

Intervention Type: DRUG

Lactoferrin

lactoferrin 100 mg

Intervention Type: DRUG

Eligibility 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

1. Pregnancy and breast feeding.

2. End stage hepatic disease.

3. End stage renal disease -

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tanta University

OTHER

Sponsor Role: lead

Responsible Party

Alaa Mohamed Hemida

Dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alaa Hemida

Role: PRINCIPAL_INVESTIGATOR

Tanta University

Locations

Tanta

Tanta, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Alaa Hemida

Role: CONTACT

Alaa.hemida@pharm.tanta.efu.eg

667867

Alaa Hemida

Role: CONTACT

35677

Other Identifiers

metformin and lactoferrin

Identifier Type: -

Identifier Source: org_study_id