NCT05315557

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

Status unknown NA Last updated 7 April 2022

What this trial tests

NA trial testing Terlipressin in Septic Shock in 100 participants. Status unknown.

Timeline

5 April 2022

Primary endpoint
31 March 2023

31 March 2023

Quick facts

Lead sponsor	Institute of Liver and Biliary Sciences, India
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	100
Start date	5 April 2022
Primary completion	31 March 2023
Estimated completion	31 March 2023
Sites	1 location across India

Drugs / interventions tested

• Terlipressin — full drug profile →
• vasopressin — full drug profile →

Conditions studied

• Septic Shock — all drugs for Septic Shock →
• Cirrhosis, Liver — all drugs for Cirrhosis, Liver →

Sponsor

Institute of Liver and Biliary Sciences, India

Who can join

Adults 18 to 70, any sex, with Septic Shock or Cirrhosis, Liver. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.