Efficacy and Safety of Vasopressin Versus Terlipressin as a Second Vasopressor in Critically Ill Cirrhotics With Septic Shock- the VITEL-C Trial

Launched by INSTITUTE OF LIVER AND BILIARY SCIENCES, INDIA · Mar 30, 2022

Keywords

ClinConnect Summary

Hypothesis: We hypothesise that vasopressin would be non-inferior to terlipressin as a second vasopressor in critically ill cirrhotics with septic shock and would have lesser adverse effects when compared to terlipressin.

Aim: To compare the efficacy of adding continuous infusion of terlipressin versus vasopressin to noradrenaline in causing improvement in systemic hemodynamics and microcirculation.

Methodology:

Study population:

1. Critically ill cirrhotic - Defined as a cirrhotic patient who presents with at least one organ failure, defined by SOFA score WITH
2. septic shock - Defined...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age 18-70yrs
• • 2. An informed consent from the patient or relative
• Exclusion Criteria:
• • 1. Age \<18 years and \> 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 \<150
• • 13. CKD
• • 14. COPD
• • 15. Severe coagulopathy - platelets \<20,000 and INR \> 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