Health Condition 1: K746- Other and unspecified cirrhosis ofliver
Conditions
Interventions
Intervention1: Terlipressin: 1mg/24 hour 1mg/24 hour and titrate according to MAP
Control Intervention1: Vasopressin: 0.03U/hour 1mg/24 hour and titrate according to MAP
Sponsors
Institute of Liver and Biliary Sciences
Eligibility
Inclusion criteria
Inclusion criteria: 1) Age 18-70 yrs 2) An informed consent from the patient or relative
Exclusion criteria
Exclusion criteria: 1. Age 70 years 2. Stroke 3. Severe sepsis requiring higher dose of noradrenaline ( >1mcg/Kg/min) 4. Myocardial dysfunction, Coronary artery disease, Arrhythmias 5. Peripheral Vascular disease 6. Gut Paralysis 7. Acute on chronic liver failure (ACLF) 8. Hepato-cellular carcinoma (HCC), intrahepatic or extrahepatic malignancy 9. Complete portal vein thrombosis 10. Hepatic vein outflow tract obstruction (HVOTO) 11. Pregnancy 12. Patients with Pa02/FiO2 ratio 13. CKD 14. COPD 15. Severe coagulopathy - platelets 4 16. Active Bleed or DIC 17. Patients already on terlipressin or vasopressin in the last 48 hours 18. Extremely moribund patients with an expected life expectancy of less than 24 hours 19. Failure to give informed consent from family members. 20. Patient enrolled in other clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement in systemic hemodynamics defined as discontinuation of noradrenaline infusion OR reversal of shock at 6 hours after randomizationTimepoint: 6 hours after randomization | — |
Secondary
| Measure | Time frame |
|---|---|
| Comparison of noradrenaline requirements between in each arm at the end of 6 hoursTimepoint: 6 hour;Days of mechanical ventilation and ICU stayTimepoint: Day 28;Decrease in Cardiac output by 10% or less than 6L after 6 hours of randomizationTimepoint: 6 hours of randomization;Endothelial function and Coagulation function will measure whenever feasibleTimepoint: Day 28;Improvement in microcirculation as measured by improvement in lactate and capillary refill time at 6, 24 and 48 hours, Near IR spectroscopy whenever feasibleTimepoint: 6, 24 and 48 hours,;Improvement in renal resistive index at 24 and 48 hoursTimepoint: 24 and 48 hours;Improvement in serum creatinine in 24 and 48 hours (Improvement in KDIGO stage at 24 and 48 hours)Timepoint: (Improvement in KDIGO stage at 24 and 48 hours);Improvement in SVR by 10% or above 500 at 6, 12 and 48 hoursTimepoint: 6, 12 and 48 hours;Incidence of adverse effects till 48 hours after randomization including incidence of rebound hypertensionTimepoint: Day 28;KDIGO criteria - increase in urine output in 6, 12,24 and 48 hoursTimepoint: 6, 12,24 and 48 hours ;Mortality at day 28Timepoint: Day 28;Reduction in dose of noradrenaline at the end of 6 hoursTimepoint: 6 hour | — |
Countries
India
Contacts
Public ContactDr Rakhi Maiwall
Institute of Liver and Biliary Sciences
Outcome results
None listed