Status:
UNKNOWN
Efficacy and Safety of Vasopressin Versus Terlipressin as a Second Vasopressor in Critically Ill Cirrhotics With Septic Shock- the VITEL-C Trial
Lead Sponsor:
Institute of Liver and Biliary Sciences, India
Conditions:
Septic Shock
Cirrhosis, Liver
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief 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 h...
Detailed Description
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 comp...
Eligibility Criteria
Inclusion
- Age 18-70yrs
- An informed consent from the patient or relative
Exclusion
- Age \<18 years and \> 70 years
- Stroke
- Severe sepsis requiring higher dose of noradrenaline (\>1mcg/Kg/min)
- Myocardial dysfunction, Coronary artery disease, Arrhythmias
- Peripheral Vascular disease
- Gut Paralysis
- Acute on chronic liver failure (ACLF)
- Hepato-cellular carcinoma (HCC), intrahepatic or extrahepatic malignancy
- Complete portal vein thrombosis
- Hepatic vein outflow tract obstruction (HVOTO)
- Pregnancy
- Patients with Pa02/FiO2 ratio \<150
- CKD
- COPD
- Severe coagulopathy - platelets \<20,000 and INR \> 4
- Active Bleed or DIC
- Patients already on terlipressin or vasopressin in the last 48 hours
- Extremely moribund patients with an expected life expectancy of less than 24 hours
- Failure to give informed consent from family members.
- Patient enrolled in other clinical trial
Key Trial Info
Start Date :
April 5 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2023
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT05315557
Start Date
April 5 2022
End Date
March 31 2023
Last Update
April 7 2022
Active Locations (1)
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1
Institute of Liver & Biliary Sciences
New Delhi, National Capital Territory of Delhi, India, 110070