Ignite Creation Date:
2024-05-06 @ 8:22 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06355726
Status:
RECRUITING
Last Update Posted:
2024-06-24
First Post:
2024-03-04
Brief Title:
Efficacy of Plasma Exchange Therapy vs Standard Medical Therapy in Severe Alcoholic Hepatitis With High Discriminant Function
Sponsor:
Institute of Liver and Biliary Sciences India
Organization:
Institute of Liver and Biliary Sciences India
Study Overview
Official Title:
Efficacy of Plasma Exchange Therapy vs Standard Medical Therapy in Severe Alcoholic Hepatitis With High Discriminant Function A Randomised Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
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:
None
Brief Summary:
Alcoholic hepatitis the most florid form of alcoholic liver disease has a very high short-term mortality of up to 50 and no specific therapies are available other than steroids Steroids also only show a limited utility in improving the short-term survival and boast no evidence of any long-term benefits Additionally only a small proportion of patients with alcoholic hepatitis are eligible to receive steroids Thus a large number of patients are either not eligible or do not respond to steroids and this group outnumbers those who do respond to steroids leaving us without any specific therapeutic options for a majority of these individuals1 Even liver transplantation is not feasible in most cases due to the presence of sepsis or recent alcohol consumption and many ethical and logistic issues are involved despite the documented safety and survival benefits of early liver transplantation in patients with severe alcoholic hepatitis SAH not responding to medical management28 Therefore newer more effective and nontransplant therapeutic options for managing severe alcoholic hepatitis are needed TPE is expected to be an effective and well-tolerated bridge therapy in patients with severe alcoholic hepatitis of moderate severity not improving on SMT and without immediate prospects for liver transplantation
Detailed Description:
Hypothesiswehypothesise that the early treatment with therapeutic plasma exchange in alcoholic hepatitis patients might improve overall survival in carefully selected patients by removing cytokines chemokines and toxic substances
Aim
To compare transplant free survival between plasma exchange therapy and standard medical therapy in severe alcoholic hepatitis
Methodology
Severe alcoholic hepatitis will be screened for the study and will be managed with SMT initially will be assessed for steroid therapy if becomes ineligible counselled for liver transplant in view of high DF and MELD if there is no options of Liver transplant in near future 1 month will be given option for PLEX but it will be decided by randomisation whether he will get SMT or PLEXHeshe will also be told that PLEX is not a approved treatment and is a trial therapy and they may or may not get benefitedPatients Patients who agreed to undergo PLEX then undergo randomisation between PLEX and SMT and allocated in either group accordingly
Control group will be administered SMT onlyCase are those who get both SMT and PLEX SMT involved empirical antibiotics as per treating physicianmultivitaminsalbumin Hepatic encephalopathy HE will be treated with lactulose and rifaximin Ascites with diuretics if not contraindicated because of renal insufficiency or HE All patients will receive salt restricted high protein diet 15 gkg of proteins either enterallyparenterally in addition to thiamine and multivitamins35 to 45 kcal kg
Cases will be administered SMT with Plasma exchange session which will be done on alternate day to a maximum of 5 sessions PLEX will be discontinued if the patients Shows sustained clinical improvement Receive liver transplantation Refuses further PLEX sessionno improvement in clinical condition and Intolerant to PLEX procedure
Study population
Age - 18-60 years
Patients with steroid ineligibleDF 80 120MELD 30 severe alcoholic hepatitisBili 5 INR 15
Study design Randomised controlled study done at Department of HepatologyInstitute of Liver and Biliary SciencesNewDelhiIndia
Aim
To compare transplant free survival between plasma exchange therapy and standard medical therapy in severe alcoholic hepatitis
Methodology
Severe alcoholic hepatitis will be screened for the study and will be managed with SMT initially will be assessed for steroid therapy if becomes ineligible counselled for liver transplant in view of high DF and MELD if there is no options of Liver transplant in near future 1 month will be given option for PLEX but it will be decided by randomisation whether he will get SMT or PLEXHeshe will also be told that PLEX is not a approved treatment and is a trial therapy and they may or may not get benefitedPatients Patients who agreed to undergo PLEX then undergo randomisation between PLEX and SMT and allocated in either group accordingly
Control group will be administered SMT onlyCase are those who get both SMT and PLEX SMT involved empirical antibiotics as per treating physicianmultivitaminsalbumin Hepatic encephalopathy HE will be treated with lactulose and rifaximin Ascites with diuretics if not contraindicated because of renal insufficiency or HE All patients will receive salt restricted high protein diet 15 gkg of proteins either enterallyparenterally in addition to thiamine and multivitamins35 to 45 kcal kg
Cases will be administered SMT with Plasma exchange session which will be done on alternate day to a maximum of 5 sessions PLEX will be discontinued if the patients Shows sustained clinical improvement Receive liver transplantation Refuses further PLEX sessionno improvement in clinical condition and Intolerant to PLEX procedure
Study population
Age - 18-60 years
Patients with steroid ineligibleDF 80 120MELD 30 severe alcoholic hepatitisBili 5 INR 15
Study design Randomised controlled study done at Department of HepatologyInstitute of Liver and Biliary SciencesNewDelhiIndia
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