The impact of continuous terlipressin infusion on complications of end-stage liver disease

Phase 3

Completed

• Conditions: Cirrhosis; Sarcopaenia; Inflammation; Malnutrition; Ascites; Infection; Immune function; Hepatic encephalopathy; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon; Musculoskeletal - Other muscular and skeletal disorders

• Registration Number: ACTRN12619000891123
• Lead Sponsor: Austin Health

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-06-26
• Study Completion: 2023-06-13
• Last Update Posted: 26 September 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Patients able to give informed consent
Age > 18 years
Patients with cirrhosis
Clinically significant ascites despite diuretic use or those requiring large volume paracentesis
Handgrip strength below average for age and gender

Exclusion Criteria

Patients who have not seen a dietician for counselling and education on the recommended high protein high energy diet, and salt restriction at least 3 months prior to the commencement of the study
Past history of vascular disease (coronary artery disease or significant other vascular disease)
Past intolerance of terlipressin
Other contraindications to terlipressin including severe congestive cardiac failure (NYHA class III or IV) and poorly controlled hypertension
Patient deemed unsuitable for the Hospital in the Home (HITH) program

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in muscle strength as measured by handgrip strength. This will be assessed using handgrip dynamometry.[ Assessed at baseline, and 12-weeks of each arm of the cross-over.];Effect on ascites, as measured by frequency and volume of paracentesis. This will be assessed via accessing medical records to record the number of attendances for paracentesis and the volumes drained each time.[ This will be evaluated at baseline and at 12-weeks for each arm of the crossover.]