Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06562803
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-15
Brief Title:
Efficacy and Safety of Cytokine Adsorption and Plasma Exchange in Patients With HBV-ACLF and Sepsis
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Efficacy and Safety of Double Plasma Cytokine Adsorption System With Sequential Low-Dose Plasma Exchange in Treating Hepatitis B-Related Acute-on-Chronic Liver Failure and Sepsis A Randomized Controlled Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study aims to evaluate the efficacy and safety of the double plasma cytokine adsorption system with sequential low-dose plasma exchange DPCASLPE in patients with hepatitis B-related acute-on-chronic liver failure HBV-ACLF complicated by sepsis The focus is on assessing the impact of the cytokine adsorption columnCA280Jafron Biomedical Co Ltd Zhuhai China on survival rates inflammation markers and organ function to determine its potential value in clinical practice
The primary research questions are 1 Does DPCASLPE artificial liver therapy improve the 4-week mortality rate in HBV-ACLF patients with sepsis 2 Does it improve the 12-week mortality rate in these patients Additionally the study examines the effects of this therapy on APACHE II scores SOFA scores vasoactive-inotropic score MELD scores and COSSH-ACLF II scores as well as the cytokine adsorption efficiency of the CA280
Patients were randomly assigned to either the DPCASLPE group or the plasma exchangePE group All patients received artificial liver therapy every other day for a total of two sessions Follow-up assessments were conducted before and after each therapy session as well as at 1 2 3 4 and 12 weeks
The primary research questions are 1 Does DPCASLPE artificial liver therapy improve the 4-week mortality rate in HBV-ACLF patients with sepsis 2 Does it improve the 12-week mortality rate in these patients Additionally the study examines the effects of this therapy on APACHE II scores SOFA scores vasoactive-inotropic score MELD scores and COSSH-ACLF II scores as well as the cytokine adsorption efficiency of the CA280
Patients were randomly assigned to either the DPCASLPE group or the plasma exchangePE group All patients received artificial liver therapy every other day for a total of two sessions Follow-up assessments were conducted before and after each therapy session as well as at 1 2 3 4 and 12 weeks
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None