CompletedPhase 3ACTRN12619000891123

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

The impact of continuous terlipressin infusion on muscle, nutrition, ascites and inflammation in end-stage liver disease


Sponsor

Austin Health

Enrollment

30 participants

Start Date

Jul 30, 2019

Study Type

Interventional

Conditions

Summary

End-stage liver disease, known as cirrhosis, is a common condition in Western society, and is associated with poor prognosis. Cirrhosis can lead to many complications, including fluid retention, kidney impairment and increased risk of infection. Many patients with cirrhosis are malnourished and also develop muscle wasting. Terlipressin is a medication used in the management of severe bleeding and some forms of kidney impairment associated with liver disease, but little is known about its impact on other complications of liver disease such as muscle wasting, fluid retention or infection. Early data from our centre suggests that terlipressin can also improve nutrition in this population. This study will attempt to confirm that long-term terlipressin can improve nutrition and muscle mass in patients with end-stage liver disease as well as understanding the mechanisms by which this occurs. It will also look at whether it improves other complications such as ascites (fluid retention in the abdominal cavity), infection, hospital admissions and healthcare costs. Participants will undertake 2 study periods: an observation period and a treatment period, where they will receive a continuous infusion of terlipressin for 12 weeks which will be administered via the Hospital-in-the-Home program. They will undergo assessment of muscle strength and function using radiology scans and bedside tests, as well as monthly blood tests during both study periods. Hospital records will be accessed to identify causes of hospital admission and estimates of infection rates and to calculate direct healthcare costs. Quality of life will be assessed using validated questionnaires. In total, the participants will be involved in the study for a period of 6 months.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Inclusion Criteria5

  • 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 Criteria5

  • 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

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

Thirty patients with cirrhosis, clinically significant ascites despite diuretic use or requiring large volume paracentesis, and lower than average handgrip strength will be invited to participate in t

Thirty patients with cirrhosis, clinically significant ascites despite diuretic use or requiring large volume paracentesis, and lower than average handgrip strength will be invited to participate in the study. Participants will be enrolled in a prospective cross-over study comprised of 2 12-week study periods: an observation period and a treatment period. There will be no washout period between each study period. All participants will undergo both the treatment and the observation periods, but will be randomly allocated by drawing a counter out of a box to begin in either the treatment period or the observation period before crossing over to the other period. During the treatment period, patients will receive a continuous infusion of terlipressin, administered as 3.4mg daily intravenously via a peripherally inserted central catheter (PICC) line. Compliance with the terlipressin treatment will be monitored by the Hospital in the Home nurses who will attend the patients home daily to change their terlipressin infusion pump. Any non-compliance (eg intentional disconnection of the pump) will be reported to the study investigators.


Locations(1)

Austin Health - Austin Hospital - Heidelberg

VIC, Australia

View Full Details on ANZCTR

For the most up-to-date information, visit the official listing.

Visit

ACTRN12619000891123


Related Trials