Home versus hospital drainage of fluid from the abdomen (ascites) for patients with advanced cirrhosis

Not Applicable

• Conditions: Complications of cirrhosis; Digestive System

• Registration Number: ISRCTN26993825
• Lead Sponsor: niversity of Sussex

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-08-15
• Last Update Posted: 13 November 2023
• Study Completion: 2026-09-30

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 310

Inclusion Criteria

Current participant inclusion criteria as of 01/11/2023:
Patient inclusion criteria:
1. Aged 18 years old and over
2. Refractory ascites due to cirrhosis (with the need for one or more LVP per month), defined as per International Ascites Club criteria (5-6):
3. Diuretic-resistant ascites: ascites that cannot be mobilized or the early recurrence of which cannot be prevented because of a lack of response to sodium restriction and diuretic treatment (spironolactone 400 mg and furosemide 160 mg) and or Diuretic-intractable ascites: ascites that cannot be mobilized or the early recurrence of which cannot be prevented because of the development of diuretic-induced complications that preclude the use of an effective diuretic dosage
4. Registered with a GP in the community Trusts served by the participating centres.

Previous participant inclusion criteria:
Patient inclusion criteria:
1. Aged 18 years old and over
2. Refractory ascites (with the need for one or more LVP per month), defined as per International Ascites Club criteria (5-6):
3. Diuretic-resistant ascites: ascites that cannot be mobilized or the early recurrence of which cannot be prevented because of a lack of response to sodium restriction and diuretic treatment (spironolactone 400 mg and furosemide 160 mg) and or Diuretic-intractable ascites: ascites that cannot be mobilized or the early recurrence of which cannot be prevented because of the development of diuretic-induced complications that preclude the use of an effective diuretic dosage
4. Registered with a GP in the community Trusts served by the participating centres.

Exclusion Criteria

Patient exclusion criteria:
1. Loculated and or chylous ascites
2. Evidence of active infection that in the investigator’s opinion would preclude insertion of LTAD (for example, bacterial peritonitis) – such patients would need to receive appropriate treatment and could then be reconsidered
3. A candidate for liver transplantation and or TIPS
4. Psychosocial issues which in the opinion of the medical team will preclude study participation
5. Pregnancy - all women of childbearing age must have a negative pregnancy test

Study & Design

• Study Type: Interventional
• Study Design: Not specified