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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
175
Nine MiU Ulinastatin in three divided doses 8 hourly for 3-5 days
Medical ICU, Jinnah Postgraduate Medical Centre
Karachi, Sindh, Pakistan
RECRUITINGPrevention of MOD's in patients with sepsis
To assess the role of Ulinastatin in preventing the onset of MODS in sepsis-induced patients. Sepsis is defnied as evidence of infection (positive culture of blood, Urine, Tracheal) or suspected infection (by a physician) plus 2 out of 4 criteria's of SIRS. MODS is presence of two or more organ dysfunction with scoring ≥2 of each organ as per Sequential Organ Failure Assessment (SOFA) score.
Time frame: Day 1 of enrollment
Prevention of MOD's in patients with sepsis
To assess the role of Ulinastatin in preventing the onset of MODS in sepsis-induced patients. Sepsis is defnied as evidence of infection (positive culture of blood, Urine, Tracheal) or suspected infection (by a physician) plus 2 out of 4 criteria's of SIRS. MODS is presence of two or more organ dysfunction with scoring ≥2 of each organ as per Sequential Organ Failure Assessment (SOFA) score.
Time frame: Day 3 of enrollment
Prevention of MOD's in patients with sepsis
To assess the role of Ulinastatin in preventing the onset of MODS in sepsis-induced patients. Sepsis is defnied as evidence of infection (positive culture of blood, Urine, Tracheal) or suspected infection (by a physician) plus 2 out of 4 criteria's of SIRS. MODS is presence of two or more organ dysfunction with scoring ≥2 of each organ as per Sequential Organ Failure Assessment (SOFA) score.
Time frame: Day 5 of enrollment
Effect on in-hospital mortality
To investigate the impact of Ulinastatin on sepsis associated mortality.
Time frame: During first 48 hours of hospital stay after enrollment
Effect on 7 days mortality
To investigate the impact of Ulinastatin on sepsis associated mortality.
Time frame: During the 7 days of enrollment
Effect on 14 days mortality
To investigate the impact of Ulinastatin on sepsis associated mortality.
Time frame: During the 14 days of enrollment
Effect on 28 days mortality
To investigate the impact of Ulinastatin on sepsis associated mortality.
Time frame: During the 28 days of enrollment
Number of days on mechanical ventilation
To explore the role of Ulinastatin in reducing the number of days on mechanical ventilation
Time frame: Up to 28 days after enrollment
Number of days in ICU
To explore the role of Ulinastatin in reducing ICU stays.
Time frame: Up to 28 days after enrollment
Prevention of Severe Sepsis in patients admitted with Sepsis
To determine the efficacy of Ulinastatin in preventing the progression of sepsis to severe sepsis. Severe sepsis is sepsis as defined above plus at least one organ/system dysfunction scoring ≥ 2 as per Sequential Organ Failure Assessment (SOFA) score.
Time frame: Up to 28 days after enrollment
Prevention of Septic Shock in patients admitted with Sepsis
To determine the efficacy of Ulinastatin in preventing the progression of sepsis to septic shock. Septic shock is persistent hypotension requiring vasopressors to maintain mean arterial pressure of 65mmHg or higher and a serum lactate level greater than 2mmol/L despite adequate volume resuscitation with 30ml/kg of crystalloid solution.
Time frame: Up to 28 days after enrollment
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