Health Condition 1: A419- Sepsis, unspecified organism
Conditions
Interventions
Intervention1: Thymosin α-1 (Tα1) and Ulinastatin: Morning two Subcutaneous injection of 1.6mg Tα1 and evening two Subcutaneous injection of 1.6mg Tα1 every 12±2 hours will be administered along
Sponsors
Dr Abdul Ansari
Eligibility
Inclusion criteria
Inclusion criteria: 1 Male or females of greater than or equal to 18 years of age at the time of consent 2 Patient who can and willing to provide written Informed Consent 3 Patient Diagnosed as a sepsis according to the sepsis diagnosis criteria in Surviving Sepsis Campaign International Guidelines for Management of Sepsis 3 and Septic Shock 2016 Patient with at least one acute severe organ failure related to sepsis and total SOFA scores greater than or equal to 4 4 Patient with confirmed or suspected infection and satisfy at least one of the following a Pathogenic microbes grow in blood and at aseptic locations b Presence of abscess or partially infected tissues c Suspected infection identified by at least one of the following evidence Leukocytes at aseptic locations CSF, blood, pleural fluid etc Organ perforation confirmed by imaging evidence, examination result or intestinal content leak during drainage Imaging evidence of pneumonia accompanied by purulent secretion and impaired gas exchange Organ Specific syndromes GI tract Biliary tract Urogenital SSI CNS
Exclusion criteria
Exclusion criteria: 1 Patient less 18 years of age 2 Patient having a medical history of allergy or intolerance to Thymosin alpha-1 (T alpha1) or Ulinastatin
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Change in SOFA score from Screening/ Baseline Visit 2.Change in CD4/CD8 ratio from Screening/ Baseline VisitTimepoint: 1. Day 1 - 7 2. Day 1 - 7 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Incidence of emerging infection within 28 day from screening. 2. Clearance rate of pathogenic microorganism. 3.Duration of hospitalization. 4.Ventilator-free days. 5.ICU-free days. 6.Continuous Renal Replacement Therapy (CRRT) free daysTimepoint: 1. Day 1 - 28. 2. 28 Days. 3. 28 days. 4. 28 days. 5. 28 days. 6. 28 days. | — |
Countries
India
Contacts
Public ContactDr Adarsh Shetty
Nanavati Super Speciality Hospital
Outcome results
None listed