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

Septic Shock Clinical Trial

— MUNI-SEP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05895240
• Other study ID #: NO.F.2-81/2022-GENL/229/JPMC
• Status: Recruiting
• Phase: Phase 4
• Start date: May 1, 2023
• Est. completion date: October 2023

Study information

• Verified date: May 2023
• Source: Jinnah Postgraduate Medical Centre
• Contact: Zeeshan Ali, FCPS
• Phone: +923211000393
• Email: dr.zeeshan.j[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 175
• Est. completion date: October 2023
• Est. primary completion date: October 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Age >18 or <60

• Sepsis, and severe sepsis, as defined in operational definitions

• Patients voluntarily agreed to participate in the study after informed consent

Exclusion Criteria:

• Fulminant hepatic failure

• Acute cerebrovascular accidents

• Acute poisoning

• Chronic Kidney Disease stage 5

• Diagnosed case of immune thrombocytopenia

• Low output cardiac failure, with left ventricular ejection fraction <20%

• Advance chronic obstructive pulmonary disease on long term oxygen therapy

• Lactation or pregnancy

Related Conditions & MeSH terms

• MODS
• Sepsis
• Septic Shock
• Severe Sepsis
• Toxemia

Intervention

Drug:
• Ulinastatin
Nine MiU Ulinastatin in three divided doses 8 hourly for 3-5 days

Locations

Country	Name	City	State
Pakistan	Medical ICU, Jinnah Postgraduate Medical Centre	Karachi	Sindh

Sponsors (1)

Lead Sponsor	Collaborator
Jinnah Postgraduate Medical Centre

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Day 1 of enrollment
Primary	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.	Day 3 of enrollment
Primary	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.	Day 5 of enrollment
Primary	Effect on in-hospital mortality	To investigate the impact of Ulinastatin on sepsis associated mortality.	During first 48 hours of hospital stay after enrollment
Primary	Effect on 7 days mortality	To investigate the impact of Ulinastatin on sepsis associated mortality.	During the 7 days of enrollment
Primary	Effect on 14 days mortality	To investigate the impact of Ulinastatin on sepsis associated mortality.	During the 14 days of enrollment
Primary	Effect on 28 days mortality	To investigate the impact of Ulinastatin on sepsis associated mortality.	During the 28 days of enrollment
Secondary	Number of days on mechanical ventilation	To explore the role of Ulinastatin in reducing the number of days on mechanical ventilation	Up to 28 days after enrollment
Secondary	Number of days in ICU	To explore the role of Ulinastatin in reducing ICU stays.	Up to 28 days after enrollment
Secondary	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.	Up to 28 days after enrollment
Secondary	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.	Up to 28 days after enrollment