CTRI/2021/04/032842
Recruiting
未知
A Prospective, Randomized Controlled Single-Center, Two-Arm ( standard control), Open Label Investigator Initiated Clinical Study to Evaluate the Efficacy and Safety of Thymosin alpha 1 (T alpha1) and Ulinastatin in Sepsis Patients
Dr Abdul Ansari0 sites0 target enrollmentTBD
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Health Condition 1: A419- Sepsis, unspecified organism
- Sponsor
- Dr Abdul Ansari
- Status
- Recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
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
Outcomes
Primary Outcomes
Not specified
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