Comparison of Bolus Versus Continuous Infusion of Terlipressin (Drug) in Liver Cirrhotic Patients (Liver Disease)

Not Applicable

• Conditions: Health Condition 1: K746- Other and unspecified cirrhosis ofliver

• Registration Number: CTRI/2021/04/032537
• Lead Sponsor: Institute of Liver and Biliary Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1) Cirrhotics with septic shock requiring norepinephrine dose >0.5ug/kg/min to maintain MAP > 65 mm Hg

2) An informed consent from the patient or relative

Exclusion Criteria

1.Patients with age less than 18 years or more than 65 years

2.Severe known cardiopulmonary disease (Hypertension, structural or valvular heart disease, coronary artery disease, arrhythmias)

3.Stroke

4.Peripheral Vascular disease

5.Gut Paralysis

6.Intestinal obstruction

7.Acute on chronic liver failure (ACLF )

8.Cancer, hepato-cellular carcinoma (HCC), intrahepatic or extrahepatic malignancy

9.Portal vein thrombosis

10.Hepatic vein outflow tract obstruction (HVOTO )

11.Pregnancy

12.Patients with Pa02/FiO2 ratio <150

13.Severe coagulopathy platelets <20,000 and INR > 4

14.Active Bleed (Mucosal or variceal)

15.Patients already on terlipressin in the last 48 hours

16.Extremely moribund patients with an expected life expectancy of less than 24 hours

17.Failure to give informed consent from family members.

18.Patient enrolled in other clinical trials

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Reversal of shockTimepoint: 72 hours

Secondary Outcome Measures

Name	Time	Method
Time to reversal of shockTimepoint: 1 year;Days of Intensive Care Unit stayTimepoint: 1 year;Days of mechanical ventilationTimepoint: 1 year;Impact on AKI (Progression, Resolution, requirement of renal replacement therapy, (RRT)Timepoint: 24 hours,day3 and day 7;Improvement in SOFA scoreTimepoint: 24 hours and day 3;Incidence of adverse effects and discontinuation of therapy due to adverse effectsTimepoint: 24 hours and day 3;Lactate clearanceTimepoint: 6,12,24 and 72 hours;MortalityTimepoint: 28 days