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

Jinnah Postgraduate Medical Centre

Status and phase: Enrolling; Phase 4

Conditions: MODS; Severe Sepsis; Septic Shock

Treatments: Drug: Ulinastatin

Study type: Interventional

Funder types: Other

Identifiers

NCT05895240

NO.F.2-81/2022-GENL/229/JPMC

Details and patient eligibility

About

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.

Full 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.

Enrollment: 175 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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175 participants in 2 patient groups

Control Group Arm

No Intervention group

Description:

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

Active Intervention Arm

Experimental group

Description:

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

Treatment:

Drug: Ulinastatin