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

• Status: Not yet recruiting
• Trial end date: 2023-03-31
• Target enrollment: 0
• Participant gender: All

Summary

Sepsis is a life-threatening organ dysfunction caused by dysregulated host response. A Subset of sepsis is septic shock which has almost 4-6 times the mortality when compared to sepsis. Septic shock has underlying cellular and metabolic abnormalities in addition to circulatory dysfunction. The circulatory dysfunction in sepsis is in the form of severe vasodilatation with high cardiac index. Cirrhosis is a state of hyperdynamic circulation. The mortality of septic shock in these group of patients is still higher.

At the onset of septic shock there is initially an increased secretion of Arginine vasopressin. However, this initial rise is short lasting, and the vasopressin levels come back to normal or low serum levels with continued hypotension. However, even normal levels are too low for the degree of hypotension in septic shock. This causes a relative deficiency of vasopressin in septic shock. The exact time when this fall happens is not known and it is likely to be variable. Vasopressin was therefore tried as an agent in septic shock. Terlipressin is a synthetic analogue of vasopressin. It has a greater selectivity for the V1 receptor. Terlipressin is also shown to be effective in septic shock in cirrhotics3. Other vasoactive agents are not preferred in cirrhotics - dopamine due to high risk of arrhythmias and dobutamine as baseline cardiac output of cirrhotics is high which further increases in sepsis and dobutamine would further add to it. However, it may be given in myocardial dysfunction. Noradrenaline is recommended as the first vasopressor to be started in general in septic shock population. No study has compared the effectiveness of vasopressin and Terlipressin when added to noradrenaline in patients with cirrhosis. Acute kidney injury is a very common complication of septic shock in cirrhotics.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Institute of Liver and Biliary Sciences, India
• Treatments: Arginine Vasopressin; Terlipressin; Vasopressins

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