Refractory Hepatic Encephalopathy Clinical Trial
Official title:
High Volume Plasmapheresis for Refractory Hepatic Encephalopathy in Liver Intensive Care Unit-A Randomized Controlled Trial
| NCT number | NCT03115697 |
| Other study ID # | ILBS-HE-01 |
| Secondary ID | |
| Status | Withdrawn |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | April 7, 2018 |
| Est. completion date | April 15, 2019 |
| Verified date | November 2019 |
| Source | Institute of Liver and Biliary Sciences, India |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
Study Design- Randomized Controlled trial Duration of enrolment-Feb-2016 to December 2017
Sample size-120 patients Methodology We will include consecutive with advanced hepatic
encephalopathy not responding to treatment of precipitants and on treatment with Lactulose
and Rifaximin for 48 hours .
Two groups will be divided. One arm -Lactulose and Rifaximin will be continued Second Arm -
Plasmapheresis will be added to the standard medical care therapy.(Maximum of 3 sessions once
in 24 hours/or alternate days with an follow up for 5 days)
| Status | Withdrawn |
| Enrollment | 0 |
| Est. completion date | April 15, 2019 |
| Est. primary completion date | April 15, 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 70 Years |
| Eligibility |
Inclusion Criteria: - Cirrhotics - Age between 18-70 years - Hepatic encephalopathy -Grade 3-4 - Patients receiving Lactulose/Rifaximin for 48 hours and not showing improvement in Hepatic encephalopathy(Persistent Grade 3/4) Exclusion Criteria: - Concomitant participation in an other clinical trial - Patient receiving sedatives(propofol,etc) 24 hours prior. - Patients with severe cardiopulmonary disease - Pregnancy - Human Immunodeficiency Virus - Hepatocellular Carcinoma or extrahepatic malignancy - Active uncontrolled sepsis with hemodynamic instability - Chronic renal insufficiency on treatment with haemodialysis - Uncontrolled bleed or patients in DIC - Extremely moribund patients with expected survival of less than 48 hours on high vasopressor support - Patients with moderate-severe Acute Respiratory Distress Syndrome (ARDS). - Patients with Non Hepatic Coma. |
| Country | Name | City | State |
|---|---|---|---|
| India | Institute of Liver and Biliary Sciences | New Delhi | Delhi |
| Lead Sponsor | Collaborator |
|---|---|
| Institute of Liver and Biliary Sciences, India |
India,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Resolution in Hepatic Encephalopathy by 2 grades in both groups | Day 5 | ||
| Secondary | Improvement in Hepatic Encephalopathy in both groups | 2 years | ||
| Secondary | Number of days of mechanical ventilation in both groups | 2 years | ||
| Secondary | Survival in both groups | 28 days | ||
| Secondary | Proportion of patients with Systemic inflammatory response syndrome (SIRS) or sepsis as precipitants of Hepatic encephalopathy in both groups. | 2 years | ||
| Secondary | Proportion of patients with failure of standard medical therapy in both groups. | 48 hours |