Clinical trial

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

Name

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

Description

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.

Trial arms

Trial start

2023-05-01

Estimated PCD

2023-10-01

Trial end

2023-10-01

Status

Recruiting

Phase

Early phase I

Treatment

Ulinastatin

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

Arms:

Active Intervention Arm

Size

175

Primary endpoint

Prevention of MOD's in patients with sepsis

Day 1 of enrollment

Prevention of MOD's in patients with sepsis

Day 3 of enrollment

Prevention of MOD's in patients with sepsis

Day 5 of enrollment

Effect on in-hospital mortality

During first 48 hours of hospital stay after enrollment

Effect on 7 days mortality

During the 7 days of enrollment

Effect on 14 days mortality

During the 14 days of enrollment

Effect on 28 days mortality

During the 28 days of enrollment

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 175, 'type': 'ESTIMATED'}}

Updated at

2023-06-08

1 organization

1 drug

3 indications

Organization

Jinnah Postgraduate Medical Centre

Drug

Indication

Indication

Indication