Clinical trial NCT05895240: Role of Ulinastatin in Preventing Severe Sepsis and Consequent Morbidities and Mortality
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
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Severe Sepsis
Septic Shock
MODS
Lead sponsor: Jinnah Postgraduate Medical Centre
Sponsor class: OTHER_GOV
First posted: 2023-06-08
Enrollment: 175
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Prevention of MOD's in patients with sepsis
timeFrame: Day 1 of enrollment
measure: Prevention of MOD's in patients with sepsis
timeFrame: Day 3 of enrollment
measure: Prevention of MOD's in patients with sepsis
timeFrame: Day 5 of enrollment
measure: Effect on in-hospital mortality
timeFrame: During first 48 hours of hospital stay after enrollment
measure: Effect on 7 days mortality
timeFrame: During the 7 days of enrollment
measure: Effect on 14 days mortality
timeFrame: During the 14 days of enrollment
measure: Effect on 28 days mortality
timeFrame: During the 28 days of enrollment
Secondary outcomes:
measure: Number of days on mechanical ventilation
timeFrame: Up to 28 days after enrollment
measure: Number of days in ICU
timeFrame: Up to 28 days after enrollment
measure: Prevention of Severe Sepsis in patients admitted with Sepsis
timeFrame: Up to 28 days after enrollment
measure: Prevention of Septic Shock in patients admitted with Sepsis
timeFrame: Up to 28 days after enrollment
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Medical ICU, Jinnah Postgraduate Medical Centre
state: Sindh
Study officials:
affiliation: Jinnah Postgraduate Medical Centre Karachi
name: Zeeshan Ali, FCPS
role: PRINCIPAL_INVESTIGATOR
References: