NCT05895240

Role of Ulinastatin in Preventing Severe Sepsis and Consequent Morbidities and Mortality

MUNI-SEP TRIAL-The Role of Ulinastatin in Preventing Severe Sepsis and Consequent Morbidities and Mortality; A Randomized Clinical Trial in Pakistan.

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 175 (estimated)
• Sponsor: Jinnah Postgraduate Medical Centre · Other Government
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

The study will enhance the theory in the frame of reference on the efficacy of Ulinastatin while managing sepsis and subsequent morbidity and mortality. Moreover, the present study will explore Ulinastatin's prophylactic role in progression of multiple organ dysfunctions. Furthermore, the study will have the clinical implications in predicting the ICU admitted patient's stay and related cost in the context of new drug. Current researches will explore the new dimensions in Pakistan's healthcare facilities, paving the way of future academics to analyze it in order to enhance healthcare outcomes.

Detailed description

The current study is a randomised clinical trial with the aim of exploring the following objectives in the context of Pakistan: * To determine the efficacy of Ulinastatin in preventing the progression of Sepsis to Severe Sepsis and septic shock. * To assess the role of Ulinastatin in preventing the onset of MODS in sepsis-induced patients. * To investigate the impact of Ulinastatin on sepsis associated mortality and morbidity. * To explore the role of Ulinastatin in reducing ICU stays and associated costs in defined patients. * To provides a condensed basis to understand ULINASTATIN as a sepsis management drug.

Conditions

• Severe Sepsis
• Septic Shock
• MODS

Interventions

Type	Name	Description
DRUG	Ulinastatin	Nine MiU Ulinastatin in three divided doses 8 hourly for 3-5 days

Timeline

• Start date: 2023-05-01
• Primary completion: 2023-10-01
• Completion: 2023-10-01
• First posted: 2023-06-08
• Last updated: 2023-06-08

Locations

1 site across 1 country: Pakistan