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Observational Data Collection Study of Ulinastatin in Patients with a life-threatening complication of an infection.

A Prospective, Multicenter, Open label, non-Randomized, noninterventional, real world, Observational Registry Study to collect effectiveness and safety data of ULIHOPE (Ulinastatin) along with the standard therapy (antibiotics) & supportive care in the management of Sepsis in Indian Patients. (PRO-ULIHOPE Study: Patient Registry of ULIHOPE) - PRO-ULIHOPE

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2019/12/022438
Enrollment
1375
Registered
2019-12-18
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: A419- Sepsis, unspecified organism

Interventions

Intervention1: NIL: NIL Control Intervention1: Nil: Nil

Sponsors

URIHK Pharmaceutical Pvt Ltd
Lead Sponsor

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
1. To determine Percentage of subjects achieving subsidence of sepsis after administrating 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 ] 2. To determine change in the available Laboratory Parameters [ Time Frame: Day 1,3,5 after enrollment ]Timepoint: Till 5 Days—

Secondary

MeasureTime frame
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 ) 3. To determine Reduction in ICU stay. 4. To determine Reduction in vasopressor use. 5. To determine Ventilator free days with the use of ULIHOPE 6. To determine Incidence of adverse events other than infusion related toxicity. 7. To determine mortality of Patients with Sepsis Timepoint: Till 5 Days—

Countries

India

Contacts

Public ContactSachin Pawar

Accutest Research Laboratories (I) Pvt.Ltd.

ajay.malle@accutestglobal.com02227780718

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026