Observational Data Collection Study of Ulinastatin in Patients with a life-threatening complication of an infection.
- Conditions
- Sepsis, unspecified organism,
- Registration Number
- CTRI/2019/12/022438
- Lead Sponsor
- URIHK Pharmaceutical Pvt Ltd
- Brief Summary
Earlier clinical trials have demonstrated that Ulinastatin is an effective and safe treatment for Sepsis. While Ulinastatin clinical trials have produced important data about treatment efficacy in management of Sepsis. This planned registry will potentially provide additional real-world data using ULIHOPE: Ulinastatin 1,00,000 IU (2 Vials) manufactured by URIHK Pharmaceutical Pvt Ltd using Active Pharmaceutical Ingredient (API) collected by the patented Resin adsorption process. ULIHOPE will be given in a 2,00,000 IU dosage, 3 times a day (TID), to help in the management of sepsis in Indian patients.
This registry will collect data from adult 1375 Sepsis Patients across 275 clinical sites in India, requiring treatment with ULIHOPE – Ulinastatin 1,00,000 IU Lyophilized for IV Infusion. As a result, data from this registry will be representative of the real-world patient experience with TID administration of ULIHOPE.
Expected Contribution of Study Results to Current Knowledge:
1. Determine Safety of Ulinastatin in real life clinical Practice, when administered three times a day.
2. Determine Effectiveness of Ulinastatin in real life clinical Practice when administered three times a day.
3. Physician experience.
4. Product experience in a real-world setting.
5. Assess clinical practice/prescribing patterns.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- All
- Target Recruitment
- 1375
- A written signed and dated data sharing informed consent from subjects or legally acceptable representative.
- Either gender of age between 18 and 65 years (both inclusive).
- Subjects with diagnosis of Sepsis.
- Subjects with hypersensitivity to Ulinastatin or any of its components.
- Subjects who are pregnant or breast feeding.
- Subjects with do-not-resuscitation order.
- Subjects transferred to hospital/nursing home at late stage of Sepsis.
- Subject with any other condition not suitable to participate as per treating Physician’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 Till 5 Days ULIHOPE – 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 ] Till 5 Days 2. To determine change in the available Laboratory Parameters [ Time Frame: Day 1,3,5 after enrollment ] Till 5 Days
- Secondary Outcome Measures
Name Time Method 1. To determine Reduction in organ dysfunction; assessed by Quick Sequential Organ Failure Assessment score. 2. To determine reduction in Acute Physiologic Assessment and Chronic Health Evaluation (APACHE II )
Trial Locations
- Locations (197)
A J Hospital and Research center
🇮🇳Kannada, KARNATAKA, India
A.J. Hospital & Research Centre
🇮🇳Kannada, KARNATAKA, India
Aashirvad Super Speciality Hospital & Trauma Centre
🇮🇳Lucknow, UTTAR PRADESH, India
Aashka Hospital
🇮🇳Gandhinagar, GUJARAT, India
Abhaya Hospital
🇮🇳Bangalore, KARNATAKA, India
Adarsha Hospital
🇮🇳Udupi, KARNATAKA, India
Aditya Hospital
🇮🇳Varanasi, UTTAR PRADESH, India
AMRI Hopitals
🇮🇳Khordha, ORISSA, India
ANAND HOSPITAL
🇮🇳Indore, MADHYA PRADESH, India
Ananthapuri Hospitals And Research Institute
🇮🇳Thiruvananthapuram, KERALA, India
Scroll for more (187 remaining)A J Hospital and Research center🇮🇳Kannada, KARNATAKA, IndiaDr Dotton Denies NaronhaPrincipal investigator8095241384dottonnoronha@gmail.com