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 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

试验速览

暂无简介。

•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

•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

发起方

Dr Abdul Ansari