Role of Ulinastatin in Preventing Severe Sepsis and Consequent Morbidities and Mortality (MUNI-SEP)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Septic Shock; Severe Sepsis; MODS
• Intervention / Treatment: Drug: Ulinastatin

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.

• Study Type: Interventional
• Enrollment (Estimated): 175
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Zeeshan Ali, FCPS; Phone Number: +923211000393; Email: dr.zeeshan.j@gmail.com
• Study Contact Backup: Name: Shamim Kausar, FCPS; Phone Number: +923343093627; Email: drshamimahsan@gmail.com

Study Locations

• Pakistan
  • Sindh
    • Karachi, Sindh, Pakistan, 71550
      • Recruiting
      • Medical ICU, Jinnah Postgraduate Medical Centre
      • Contact: Zeeshan Ali, FCPS; Phone Number: +923211000393; Email: dr.zeeshan.j@gmail.com
      • Contact: Shamim Kausar, FCPS; Phone Number: +923343093627; Email: drshamimahsan@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control Group Arm; Standard of care treatment arm, study medication will not be given
Experimental: Active Intervention Arm; This group will receive Nine MiU Ulinastatin in three divided doses 8 hourly	Drug: Ulinastatin; Nine MiU Ulinastatin in three divided doses 8 hourly for 3-5 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
Effect on in-hospital mortality	To investigate the impact of Ulinastatin on sepsis associated mortality.	During first 48 hours of hospital stay after enrollment
Effect on 7 days mortality	To investigate the impact of Ulinastatin on sepsis associated mortality.	During the 7 days of enrollment
Effect on 14 days mortality	To investigate the impact of Ulinastatin on sepsis associated mortality.	During the 14 days of enrollment
Effect on 28 days mortality	To investigate the impact of Ulinastatin on sepsis associated mortality.	During the 28 days of enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Number of days in ICU	To explore the role of Ulinastatin in reducing ICU stays.	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.	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.	Up to 28 days after enrollment

Collaborators and Investigators

• Sponsor: Jinnah Postgraduate Medical Centre
• Investigators: Principal Investigator: Zeeshan Ali, FCPS, Jinnah Postgraduate Medical Centre Karachi

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2023
• Primary Completion (Estimated): October 1, 2023
• Study Completion (Estimated): October 1, 2023

Study Registration Dates

• First Submitted: May 13, 2023
• First Submitted That Met QC Criteria: May 31, 2023
• First Posted (Actual): June 8, 2023

Study Record Updates

• Last Update Posted (Actual): June 8, 2023
• Last Update Submitted That Met QC Criteria: May 31, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Sepsis; Toxemia; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protease Inhibitors; Serine Proteinase Inhibitors; Trypsin Inhibitors; Urinastatin
• Other Study ID Numbers: NO.F.2-81/2022-GENL/229/JPMC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No