Role of Ulinastatin in Preventing Severe Sepsis and Consequent Morbidities and Mortality

NCT05895240 | Unknown Phase 4 DMC

• 1 other identifier: NO.F.2-81/2022-GENL/229/JPMC
• Study Type: interventional
• Target: 175
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Severe Sepsis; Septic Shock; MODS

Outcome Measures

Primary Outcomes (7)

• Prevention of MOD's in patients with sepsis

  To assess the role of Ulinastatin in preventing the onset of MODS in sepsis-induced patients. Sepsis is defnied as evidence of infection (positive culture of blood, Urine, Tracheal) or suspected infection (by a physician) plus 2 out of 4 criteria's of SIRS. MODS is presence of two or more organ dysfunction with scoring ≥2 of each organ as per Sequential Organ Failure Assessment (SOFA) score.

  Day 1 of enrollment

• Prevention of MOD's in patients with sepsis

  To assess the role of Ulinastatin in preventing the onset of MODS in sepsis-induced patients. Sepsis is defnied as evidence of infection (positive culture of blood, Urine, Tracheal) or suspected infection (by a physician) plus 2 out of 4 criteria's of SIRS. MODS is presence of two or more organ dysfunction with scoring ≥2 of each organ as per Sequential Organ Failure Assessment (SOFA) score.

  Day 3 of enrollment

• Prevention of MOD's in patients with sepsis

  To assess the role of Ulinastatin in preventing the onset of MODS in sepsis-induced patients. Sepsis is defnied as evidence of infection (positive culture of blood, Urine, Tracheal) or suspected infection (by a physician) plus 2 out of 4 criteria's of SIRS. MODS is presence of two or more organ dysfunction with scoring ≥2 of each organ as per Sequential Organ Failure Assessment (SOFA) score.

  Day 5 of enrollment

• Effect on in-hospital mortality

  To investigate the impact of Ulinastatin on sepsis associated mortality.

  During first 48 hours of hospital stay after enrollment

• Effect on 7 days mortality

  To investigate the impact of Ulinastatin on sepsis associated mortality.

  During the 7 days of enrollment

• Effect on 14 days mortality

  To investigate the impact of Ulinastatin on sepsis associated mortality.

  During the 14 days of enrollment

• Effect on 28 days mortality

  To investigate the impact of Ulinastatin on sepsis associated mortality.

  During the 28 days of enrollment

Secondary Outcomes (4)

• Number of days on mechanical ventilation

  Up to 28 days after enrollment

• Number of days in ICU

  Up to 28 days after enrollment

• Prevention of Severe Sepsis in patients admitted with Sepsis

  Up to 28 days after enrollment

• Prevention of Septic Shock in patients admitted with Sepsis

  Up to 28 days after enrollment

Study Arms (2)

Control Group Arm

NO INTERVENTION

Standard of care treatment arm, study medication will not be given

Active Intervention Arm

EXPERIMENTAL

This group will receive Nine MiU Ulinastatin in three divided doses 8 hourly

Drug: Ulinastatin

Interventions

Ulinastatin DRUG

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

Active Intervention Arm

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age \>18 or \<60
• Sepsis, and severe sepsis, as defined in operational definitions
• Patients voluntarily agreed to participate in the study after informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Jinnah Postgraduate Medical Centre: lead

Study Sites (1)

Medical ICU, Jinnah Postgraduate Medical Centre

Karachi, Sindh, 71550, Pakistan

RECRUITING

MeSH Terms

Conditions

Sepsis; Shock, Septic; Multiple Organ Failure

Interventions

urinastatin

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Study Officials

• Zeeshan Ali, FCPS

  Jinnah Postgraduate Medical Centre Karachi

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zeeshan Ali, FCPS

CONTACT

+923211000393; dr.zeeshan.j@gmail.com

Shamim Kausar, FCPS

CONTACT

+923343093627; drshamimahsan@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 13, 2023
• First Posted: June 8, 2023
• Study Start: May 1, 2023
• Primary Completion: October 1, 2023
• Study Completion: October 1, 2023
• Last Updated: June 8, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)