Ignite Creation Date:
2024-05-06 @ 5:42 PM
Last Modification Date:
2024-10-26 @ 2:33 PM
Study NCT ID:
NCT05391789
Status:
UNKNOWN
Last Update Posted:
2022-05-26
First Post:
2021-12-28
Brief Title:
Clinical Efficacy of Ulinastatin for Treatment of Sepsis With Systemic Inflammatory Response Syndrome
Sponsor:
Huashan Hospital
Organization:
Huashan Hospital
Study Overview
Official Title:
Clinical Efficacy of Ulinastatin for Treatment of Sepsis With Systemic Inflammatory Response Syndrome a Multicenter Randomized Double-blind Multi Dose and Placebo-controlled Clinical Trial
Status:
UNKNOWN
Status Verified Date:
2022-05
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CURE-SepSIRS
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 play a vital role in the pathogenesis of sepsis Ulinastatin UTI is a glycoprotein that exists in human blood and can be isolated and purified from human urine It is a broad-spectrum protease inhibitor Previous studies have shown that Ulinastatin may have the effect of treating sepsis
120 septic patients with systemic inflammatory response syndrome would be recruited and randomly assigned to the ordinary dose group high dose group and placebo control group according to the ratio of 111
The trial will be followed up on days 0 1 3 5 7 and 28 Sofa on day 7 compared with baseline and all-cause mortality on day 28 were investigated to explore the efficacy of ulinastatin in the treatment of adult sepsis patients with systemic inflammatory response syndrome
120 septic patients with systemic inflammatory response syndrome would be recruited and randomly assigned to the ordinary dose group high dose group and placebo control group according to the ratio of 111
The trial will be followed up on days 0 1 3 5 7 and 28 Sofa on day 7 compared with baseline and all-cause mortality on day 28 were investigated to explore the efficacy of ulinastatin in the treatment of adult sepsis patients with systemic inflammatory response syndrome
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 ordinary dose group high dose group and placebo control group according to the ratio of 111 and the evaluation of basic clinical information of subjects will be supplemented and improvedThe ordinary dose group will receive 400000 units of ulinastatin which will be injected intravenously every 8 hours The high-dose group will receive 800000 units of ulinastatin intravenously every 8 hours and the control group will use equal volume solvent 50ml normal saline as placebo intravenously every 8 hours When the patient does not have systemic inflammatory response syndrome the dose will be halved and then continue to be used for 2 days The total course of Ulinastatin injection shall be at least 3 days
Inclusion criteria
1 Adults 18 years old and 80 years old 2 meet the sepsis-30 standard specified by the American Society of critical care medicine and the European Society of critical care medicine 3 sepsis diagnosis time 48h 4 systemic inflammatory response syndrome SIRS 5 obtain the informed consent signed by the patient or authorized immediate family members
Exclusion criteria
1 Congestive heart failure NYHA grade IV cardiac function cerebrovascular accident or acute coronary syndrome within 3 months cardiac arrest in this hospital or within 7 days non infectious cardiogenic shock uncontrolled acute bleeding 2 severe chronic liver disease child Pugh grade C liver parenchymal disease with significant portal hypertension Acute liver failure 3 chronic renal failure who had received dialysis treatment before enrollment 4 severe abnormal coagulation function isth-dic score 5 points 5 significant immune abnormalities damage organ or bone marrow transplantation and moderate and severe leucopenia within 3 months before screening such as neutrophils 15 109 L received radiotherapy or chemotherapy within 3 months HIV seropositive hematological lymphatic system tumor active period 6 received Xuebijing thymosin or gamma globulin treatment within 3 months before study enrollment 7 others allergic to study drugs pregnancy lactation participated in other clinical trials within 3 months and other situations that researchers think are not suitable to participate
The trial will be followed up on days 0 1 3 5 7 and 28 The changes of sofa on day 7 compared with baseline all-cause mortality on day 28 ICU hospitalization time antibiotic use time SIRS duration vasoactive drug time mechanical ventilation time CRRT time infection and inflammation indexes coagulation and fibrinolysis indexes liver function renal function nervous and mental system function and endothelial cell function were compared To explore the efficacy of ulinastatin in the treatment of adult sepsis patients with systemic inflammatory response syndrome
Inclusion criteria
1 Adults 18 years old and 80 years old 2 meet the sepsis-30 standard specified by the American Society of critical care medicine and the European Society of critical care medicine 3 sepsis diagnosis time 48h 4 systemic inflammatory response syndrome SIRS 5 obtain the informed consent signed by the patient or authorized immediate family members
Exclusion criteria
1 Congestive heart failure NYHA grade IV cardiac function cerebrovascular accident or acute coronary syndrome within 3 months cardiac arrest in this hospital or within 7 days non infectious cardiogenic shock uncontrolled acute bleeding 2 severe chronic liver disease child Pugh grade C liver parenchymal disease with significant portal hypertension Acute liver failure 3 chronic renal failure who had received dialysis treatment before enrollment 4 severe abnormal coagulation function isth-dic score 5 points 5 significant immune abnormalities damage organ or bone marrow transplantation and moderate and severe leucopenia within 3 months before screening such as neutrophils 15 109 L received radiotherapy or chemotherapy within 3 months HIV seropositive hematological lymphatic system tumor active period 6 received Xuebijing thymosin or gamma globulin treatment within 3 months before study enrollment 7 others allergic to study drugs pregnancy lactation participated in other clinical trials within 3 months and other situations that researchers think are not suitable to participate
The trial will be followed up on days 0 1 3 5 7 and 28 The changes of sofa on day 7 compared with baseline all-cause mortality on day 28 ICU hospitalization time antibiotic use time SIRS duration vasoactive drug time mechanical ventilation time CRRT time infection and inflammation indexes coagulation and fibrinolysis indexes liver function renal function nervous and mental system function and endothelial cell function were compared To explore the efficacy of ulinastatin in the treatment of adult sepsis patients with systemic inflammatory response syndrome
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None