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

Primary Purpose

Severe Sepsis, Septic Shock, MODS

Status
Recruiting
Phase
Phase 4
Locations
Pakistan
Study Type
Interventional
Intervention
Ulinastatin
Sponsored by
Jinnah Postgraduate Medical Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Severe Sepsis

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Medical ICU, Jinnah Postgraduate Medical CentreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control Group Arm

Active Intervention Arm

Arm Description

Standard of care treatment arm, study medication will not be given

This group will receive Nine MiU Ulinastatin in three divided doses 8 hourly

Outcomes

Primary Outcome Measures

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.
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.
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.
Effect on in-hospital mortality
To investigate the impact of Ulinastatin on sepsis associated mortality.
Effect on 7 days mortality
To investigate the impact of Ulinastatin on sepsis associated mortality.
Effect on 14 days mortality
To investigate the impact of Ulinastatin on sepsis associated mortality.
Effect on 28 days mortality
To investigate the impact of Ulinastatin on sepsis associated mortality.

Secondary Outcome Measures

Number of days on mechanical ventilation
To explore the role of Ulinastatin in reducing the number of days on mechanical ventilation
Number of days in ICU
To explore the role of Ulinastatin in reducing ICU stays.
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.
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.

Full Information

First Posted
May 13, 2023
Last Updated
May 31, 2023
Sponsor
Jinnah Postgraduate Medical Centre
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1. Study Identification

Unique Protocol Identification Number
NCT05895240
Brief Title
Role of Ulinastatin in Preventing Severe Sepsis and Consequent Morbidities and Mortality
Acronym
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.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2023 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
October 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Jinnah Postgraduate Medical Centre

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Severe Sepsis, Septic Shock, MODS

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
175 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control Group Arm
Arm Type
No Intervention
Arm Description
Standard of care treatment arm, study medication will not be given
Arm Title
Active Intervention Arm
Arm Type
Experimental
Arm Description
This group will receive Nine MiU Ulinastatin in three divided doses 8 hourly
Intervention Type
Drug
Intervention Name(s)
Ulinastatin
Intervention Description
Nine MiU Ulinastatin in three divided doses 8 hourly for 3-5 days
Primary Outcome Measure Information:
Title
Prevention of MOD's in patients with sepsis
Description
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
Title
Prevention of MOD's in patients with sepsis
Description
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
Title
Prevention of MOD's in patients with sepsis
Description
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
Title
Effect on in-hospital mortality
Description
To investigate the impact of Ulinastatin on sepsis associated mortality.
Time Frame
During first 48 hours of hospital stay after enrollment
Title
Effect on 7 days mortality
Description
To investigate the impact of Ulinastatin on sepsis associated mortality.
Time Frame
During the 7 days of enrollment
Title
Effect on 14 days mortality
Description
To investigate the impact of Ulinastatin on sepsis associated mortality.
Time Frame
During the 14 days of enrollment
Title
Effect on 28 days mortality
Description
To investigate the impact of Ulinastatin on sepsis associated mortality.
Time Frame
During the 28 days of enrollment
Secondary Outcome Measure Information:
Title
Number of days on mechanical ventilation
Description
To explore the role of Ulinastatin in reducing the number of days on mechanical ventilation
Time Frame
Up to 28 days after enrollment
Title
Number of days in ICU
Description
To explore the role of Ulinastatin in reducing ICU stays.
Time Frame
Up to 28 days after enrollment
Title
Prevention of Severe Sepsis in patients admitted with Sepsis
Description
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
Title
Prevention of Septic Shock in patients admitted with Sepsis
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zeeshan Ali, FCPS
Phone
+923211000393
Email
dr.zeeshan.j@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Shamim Kausar, FCPS
Phone
+923343093627
Email
drshamimahsan@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zeeshan Ali, FCPS
Organizational Affiliation
Jinnah Postgraduate Medical Centre Karachi
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical ICU, Jinnah Postgraduate Medical Centre
City
Karachi
State/Province
Sindh
ZIP/Postal Code
71550
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zeeshan Ali, FCPS
Phone
+923211000393
Email
dr.zeeshan.j@gmail.com
First Name & Middle Initial & Last Name & Degree
Shamim Kausar, FCPS
Phone
+923343093627
Email
drshamimahsan@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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

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