Beta-blockade to reduce energy expenditure in cirrhosis

Phase 2

Completed

• Conditions: iver cirrhosis; Liver cirrhosis; Other - Conditions of unknown or disputed aetiology (such as chronic fatigue syndrome/myalgic encephalomyelitis)

• Registration Number: ACTRN12607000546459
• Lead Sponsor: Associate Professor Lindsay Plank

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-10-23
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

Liver cirrhosis, no contra-indications to beta-blockers (history of bronchospasm, severe peripheral vascular disease, complete heart block, previous intolerance to b-blockers, brittle diabetes characterised by recurrent hypoglycaemia), clinically stable and no major complication of liver disease within 1 month of entry, age over 18 years and ability to give informed consent.

Exclusion Criteria

Patients requiring primary prophylaxis with beta-blockers, pregnancy, hepatocellular carcinoma, listed for liver transplantation at the time of enrolment.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in resting energy expenditure (measured by Deltatrac metabolic monitor)after 3-months treatment (with appropriate adjustment for change in metabolising mass of the body).[Beginning and end of each 3-month phase.]

Secondary Outcome Measures

Name	Time	Method
Total body protein (measured by in vivo prompt-gamma neutron activation analysis).[Beginning and end of each 3-month phase.];Quality of life (Short Form 36).[Beginning and end of each 3-month phase.];Skeletal muscle function (grip strength by Lafayette dynamometer and respiratory muscle strengthby Validyne pressure transducer).[Beginning and end of each 3-month phase.]