Comparison of Bolus Versus Continuous Infusion of Terlipressin Cirrhotic Patients With Septic Shock.

Launched by INSTITUTE OF LIVER AND BILIARY SCIENCES, INDIA · Mar 23, 2021

Keywords

ClinConnect Summary

Methodology:

* Study population: All the consecutive patients of cirrhosis admitted to Intensive care unit of Hepatology department of ILBS will be evaluated for inclusion
* Study design: Prospective open label randomised controlled study -superiority trial. The study will be conducted in Department of Hepatology ILBS- intensive care unit.
* Study period: 1 year from ethics approval (Feb 21- Jan 22)
* Sample size: Assuming that the response rate is 90% in continuous and 80% in bolus , with α=5% β=80% and the superiority margin taken as 10%; then we need to enroll 141 cases in each arm, fur...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • - Cirrhotics including ACLF with septic shock requiring norepinephrine dose \>0.5ug/kg/min to maintain MAP\> 65 mm Hg
• • - An informed consent from the patient or relative
• Exclusion Criteria:
• • Patients with age less than 18 years or more than 65 years
• • Severe known cardiopulmonary disease (Hypertension, structural or valvular heart disease, coronary artery disease, arrhythmias)
• • Stroke
• • Peripheral Vascular disease
• • Gut Paralysis
• • Intestinal obstruction
• • Cancer, hepato-cellular carcinoma (HCC), intrahepatic or extrahepatic malignancy
• • Portal vein thrombosis
• • Hepatic vein outflow tract obstruction (HVOTO )
• • Pregnancy
• • Patients with Pa02/FiO2 ratio \<150
• • Severe coagulopathy platelets \<20,000 and INR \> 4
• • Active Bleed (Mucosal or variceal)
• • Patients already on terlipressin 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 trials