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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

175 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-01

Study Completion Date

2023-10-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Severe Sepsis Septic Shock MODS

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Control Group Arm

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Active Intervention Arm

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

Group Type EXPERIMENTAL

Ulinastatin

Intervention Type DRUG

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

Interventions

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Ulinastatin

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No