Status:
UNKNOWN
Clinical Efficacy of Ulinastatin for Treatment of Sepsis With Systemic Inflammatory Response Syndrome
Lead Sponsor:
Huashan Hospital
Conditions:
Sepsis
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief Summary
Sepsis is a life-threatening organ dysfunction caused by the maladjusted response of the host to infection. It is a clinical syndrome with high mortality. Studies have confirmed that many cytokines pl...
Detailed Description
The study plans to recruit 120 septic patients with systemic inflammatory response syndrome. After signing the informed consent, they will be included as day 0. They will be randomly assigned to the o...
Eligibility Criteria
Inclusion
- sepsis-3 specified by SCCM and ESICM 1) suspected or confirmed infection: diagnosed by a clinician 2) evidence of acute organ dysfunction: for patients without chronic organ dysfunction in the past (assuming a baseline SOFA score of 0): sofa ≥ 2 points from 48 hours before diagnosis of infection to 24 hours after diagnosis of infection for patients with chronic organ dysfunction in the past (SOFA score should be based on baseline): the increase of sofa ≥ 2 points from 48 hours before diagnosis of infection to 24 hours after diagnosis of infection
- diagnosis of sepsis for less than 48 hours
- Systemic inflammatory response syndrome (SIRS) 1) body temperature \> 38 ℃ or \< 36 ℃ 2) heart rate \> 90 3) respiratory rate\> 20 4) WBC count \> 12 × 10 \^ 9 / L or \< 4 × 10\^9/L (\>12000/ μ L or \< 4000/ μ L or immature granulocytes \> 10%)
- Obtained informed consent signed by the patient or authorized immediate family member
Exclusion
- Congestive heart failure (NYHA heart function level 4), cerebrovascular accident or acute coronary syndrome within 3 months, cardiac arrest within 7 days of this hospitalization, non-infectious cardiogenic shock, uncontrolled acute bleeding
- Severe chronic liver disease (Child-Pugh grade C), liver parenchymal lesions with obvious portal hypertension, acute liver failure
- Chronic renal failure, received dialysis treatment before being selected
- Severe coagulation function: ISTH-DIC score ≥ 5 points
- Significant immune abnormality/injury: received organ or bone marrow transplantation within 3 months before screening, moderate to severe leukopenia such as neutrophils \<1.5×10\^9/L, received radiotherapy or chemotherapy within 3 months , HIV seropositivity, active blood/lymphatic system tumor
- Have received Xuebijing, thymosin or gamma globulin treatment within 3 months before being selected for the study
- Others: allergies to study drugs, pregnancy, breast-feeding, participating in other clinical trials within 3 months, and other conditions deemed unsuitable by the investigator.
Key Trial Info
Start Date :
July 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2023
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT05391789
Start Date
July 1 2022
End Date
December 1 2023
Last Update
May 26 2022
Active Locations (1)
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1
Huashan Hospital affiliated to Fudan University
Jingan, Shanghai Municipality, China