Ulinastatin in patient with Trauma to prevent progression to multiple organ dysfunction

A Prospective Multi-Centric Double-Blind Randomized Phase IV Clinical Trial To Compare The Efficacy And Safety Of Ulinastatin Versus Placebo Along With Standard Supportive Care In Prevention Of Multiple Organ Dysfunction Syndrome due to worsening of Sepsis In Patients With Moderate to Severe Injury

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2012/11/003144

Enrollment

400

Registered

2012-11-26

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: null- multiple organ dysfunction syndrome Health Condition 2: R651- Systemic inflammatory response syndrome (SIRS) of non-infectious origin

Interventions

Intervention1: Ulinastatin: Ulinastatin 2 lac IU twice daily for 5 days Control Intervention1: Placebo: Placebo 2 vials twice a day with standard supportive treatment for 5 days

Eligibility

Inclusion criteria

Inclusion criteria: I. Age >18yrs II. Patients with potentially life threatening injury (ISS >= 9 and RTS >= 6) III. Drug administration should commence within 24 hours of injury IV. Evidence of SIRS and/or sepsis

Exclusion criteria

Exclusion criteria: Pregnant or breast-feeding. 2. Age 65yrs. 3. Very severe injury wherein patient is unlikely to survive till the end of Investigational Product. 4. Patients with severe head injury (Glasgow Coma Scale 5. Known case of major co-morbid (medical) illnesses. 6. Known case of chronic cardiac, kidney, lung or liver disease. 7. Known case of immunocompromised / Immunosuppressed status. 8. Participation in another investigational study within 30 days before thecurrent study.

Design outcomes

Primary

Measure	Time frame
Primary Efficacy Parameters: 1. Reduction in percentage of trauma patients developing Multiple Organ Dysfunction Syndrome (MODS) 2. Reduction in interventions during hospitalization Timepoint: Till Discharge/Day 30	—

Secondary

Measure	Time frame
Primary Efficacy Parameters: 1. Reduction in percentage of trauma patients developing Systemic inflammatory Response Syndrome and progressing to Multiple Organ Dysfunction Syndrome (MODS) 2. Reduction in Mortality 3. Reduction in days of hospitalization Timepoint: Till discharge /Day 30	—

Countries

India

Contacts

Public ContactMs Najy Turakhia

Lokmanya Tilak Muncipal General Hospital & Lokmanya Tilak Muncipal Medical College

drdharap@hotmail.com

Outcome results

None listed

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