Acute on Chronic Liver Failure
Conditions
Brief summary
Acute portal hypertension, as measured by rapid rise in hepatic venous pressure gradient (HVPG) can lead to further dreaded complications, including acute variceal bleeding (AVB) AVB: 6-week mortality rates of around 15-20% in patients with chronic liver disease without ACLF.The overall prevalence of UGH in cirrhotic patients with AD was 34.4% and 35.7% in patients with ACLF.AVB is a well-recognized precipitant leading to the occurrence and development of ACLF. AVB is a well-recognized precipitant leading to the occurrence and development of ACLF. Medical therapy for esophageal variceal bleeding (EVB) aims to reduce the splanchnic blood flow and portal pressure. The most common vasoactive agents include terlipressin, vasopressin, somatostatin, and octreotide.
Detailed description
Aim and Objective - To assess the safety and efficacy of continuous terlipressin vs. Bolus terlipressin in the management of acute esophageal variceal bleeding in ACLF. Study population: Adult patients (age ≥ 18 years) diagnosed with ACLF presenting with upper GI bleeding due to esophageal varices Study design: Pilot study Study period: 1 year Sample size: 60 Intervention: Group I- Intravenous terlipressin (administered as a continuous infusion at 4 mg/24 hours). After 12 hours, if the hepatic venous pressure gradient (HVPG) does not show a reduction of less than 10%, increase the dose to 6 mg/24 hours. Group II- Intravenous terlipressin (2 mg initially every 4 hourly for 2 days and then 1 mg every 4 hrs) Monitoring and assessment: All patients would undergo vital and baseline parameter screening before randomization. Based on randomization they will receive either steroid or plasma exchange followed by steroid Adverse effects: Acute Diarrhea, chest pain, Arterial hypertension, Cardiac arrhythmias, Acute abdomen Stopping rule: chest pain, alteration of ECG, cyanosis, bradycardia, severe allergic rashes
Interventions
Terlipressin Injectable Product
Sponsors
Institute of Liver and Biliary Sciences, India
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Adult patients (age ≥ 18 years) diagnosed with ACLF presenting with due to esophageal varices bleeding.
Exclusion criteria
1. Age \< 18 years 2. History of coronary heart disease or ventricular arrhythmia, 3. Stroke or transient ischemic attack, 4. Bronchial asthma, 5. Epilepsy, 6. Pregnancy, 7. Rebleeding. 8. HCC 9. Gastric variceal bleed
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hepatic venous Pressure Gradient (HVPG) reduction of more than 10% from baseline at 12-24 hours in both arms. | 12-24 hours |
Secondary
| Measure | Time frame |
|---|---|
| Terlipressin-related complications within 5 days i.e. safety of the drug | 5 days |
| Number of blood transfusions at 5 days | 5 days |
| Failure to control hemostasis | 5 days |
| Incidence of post-bleed Acute Kidney Injury within 5 days | 5 days |
| 6 weeks mortality in both groups. | 6 weeks |
| Rebleed within 42 day | 42 days |
Countries
India
Contacts
Primary ContactDr Khushboo Yadav, MD
Backup ContactDr Vinod S Arora, DM
Outcome results
None listed