Metformin and Lactoferrin in Sepsis in Icu
Comparative Study to Evaluate the Safety and Possible Efficacy of Metformin Versus Lactoferrin in ICU Patients With
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 sepsis
Started Apr 2024
Shorter than P25 for phase_2 sepsis
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 4, 2023
CompletedFirst Posted
Study publicly available on registry
December 26, 2023
CompletedStudy Start
First participant enrolled
April 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 9, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 9, 2024
CompletedApril 19, 2024
April 1, 2024
2 months
December 4, 2023
April 17, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The primary endpoint is mortality rate
28 days
Study Arms (2)
Group1: Metformin
ACTIVE COMPARATORGroup1: (Metformin, n=30) who will receive metformin 500 mg three times daily.
Group 2 :Lactoferrin
ACTIVE COMPARATORGroup 2 :(Lactoferrin, n=30) who will receive lactoferrin 100 mg three times daily
Interventions
Eligibility Criteria
You may qualify if:
- Age more than 18 years old.
- A diagnosis of sepsis according to the latest Sepsis definition.11
- Estimated GFR \>45 ml/minute.
You may not qualify if:
- Pregnancy and breast feeding.
- End stage hepatic disease.
- End stage renal disease -
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tanta Universitylead
Study Sites (1)
Tanta
Tanta, Egypt
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alaa Hemida
Tanta University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr
Study Record Dates
First Submitted
December 4, 2023
First Posted
December 26, 2023
Study Start
April 1, 2024
Primary Completion
June 9, 2024
Study Completion
June 9, 2024
Last Updated
April 19, 2024
Record last verified: 2024-04
Data Sharing
- IPD Sharing
- Will not share