Observational Data Collection Study of Ulinastatin in Patients with a life-threatening complication of an infection.
Not Applicable
- Conditions
- Health Condition 1: A419- Sepsis, unspecified organism
- Registration Number
- CTRI/2019/12/022438
- Lead Sponsor
- RIHK Pharmaceutical Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1. A written signed and dated data sharing informed consent from subjects or legally
acceptable representative.
2. Either gender of age between 18 and 65 years (both inclusive).
3. Subjects with diagnosis of Sepsis.
Exclusion Criteria
1. Subjects with hypersensitivity to Ulinastatin or any of its components.
2. Subjects who are pregnant or breast feeding.
3. Subjects with do-not-resuscitation order.
4. Subjects transferred to hospital/nursing home at late stage of Sepsis.
5. Subject with any other condition not suitable to participate as per treating Physicianâ??s discretion.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. To determine Percentage of subjects achieving subsidence of sepsis after administrating <br/ ><br>ULIHOPE â?? Ulinastatin 1,00,000 IU (2 Vials) three times a day for 5 days along with standard antibiotics & supportive care (evidence by normalization of heart rate, respiratory rate and core body temperature). [ Time Frame: till Day 5 after enrolment ] <br/ ><br>2. To determine change in the available Laboratory Parameters [ Time Frame: Day 1,3,5 after enrollment ]Timepoint: Till 5 Days
- Secondary Outcome Measures
Name Time Method 1. To determine Reduction in organ dysfunction; assessed by Quick Sequential Organ Failure Assessment score. <br/ ><br>2. To determine reduction in Acute Physiologic Assessment and Chronic Health Evaluation (APACHE II ) <br/ ><br>3. To determine Reduction in ICU stay. <br/ ><br>4. To determine Reduction in vasopressor use. <br/ ><br>5. To determine Ventilator free days with the use of ULIHOPE <br/ ><br>6. To determine Incidence of adverse events other than infusion related toxicity. <br/ ><br>7. To determine mortality of Patients with Sepsis <br/ ><br>Timepoint: Till 5 Days