Health Condition 1: K746- Other and unspecified cirrhosis ofliver
Conditions
Interventions
Intervention1: Terlipressin Bolus Arm and Standard of care: Terlipressin Bolus Arm
Dose: 0.5 mg QID
Frequency: QID
Route of administration: Intravenous
Duration of therapy:72 hours
Control Interv
Sponsors
Institute of Liver and Biliary Sciences
Eligibility
Inclusion criteria
Inclusion criteria: 1) Cirrhotics with septic shock requiring norepinephrine dose >0.5ug/kg/min to maintain MAP > 65 mm Hg 2) An informed consent from the patient or relative
Exclusion criteria
Exclusion criteria: 1. Patients with age less than 18 years or more than 65 years 2. Severe known cardiopulmonary disease (Hypertension, structural or valvular heart disease, coronary artery disease, arrhythmias) 3. Stroke 4. Peripheral Vascular disease 5. Gut Paralysis 6. Intestinal obstruction 7. Acute on chronic liver failure (ACLF ) 8. Cancer, hepato-cellular carcinoma (HCC), intrahepatic or extrahepatic malignancy 9. Portal vein thrombosis 10. Hepatic vein outflow tract obstruction (HVOTO ) 11. Pregnancy 12. Patients with Pa02/FiO2 ratio 13. Severe coagulopathy platelets 4 14. Active Bleed (Mucosal or variceal) 15. Patients already on terlipressin in the last 48 hours 16. Extremely moribund patients with an expected life expectancy of less than 24 hours 17. Failure to give informed consent from family members. 18. Patient enrolled in other clinical trials
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reversal of shockTimepoint: 72 hours | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to reversal of shockTimepoint: 1 year;Days of Intensive Care Unit stayTimepoint: 1 year;Days of mechanical ventilationTimepoint: 1 year;Impact on AKI (Progression, Resolution, requirement of renal replacement therapy, (RRT)Timepoint: 24 hours,day3 and day 7;Improvement in SOFA scoreTimepoint: 24 hours and day 3;Incidence of adverse effects and discontinuation of therapy due to adverse effectsTimepoint: 24 hours and day 3;Lactate clearanceTimepoint: 6,12,24 and 72 hours;MortalityTimepoint: 28 days | — |
Countries
India
Contacts
Public ContactDr Rakhi Maiwall
Institute of Liver and Biliary Sciences
Outcome results
None listed