Effects of Treatment of Ascites by the ALFApump System on Renal and Circulatory Function

Effects of Treatment of Ascites by the ALFApump System on Renal and Circulatory Function in Patients With Cirrhosis and Recurrent or Refractory Ascites

This is a single centre, prospective, uncontrolled study to include 12 consecutive patients with cirrhosis of the liver and recurrent or refractory ascites. The main aim (primary objective) of the study is to investigate the effect of treatment of ascites by the Sequana medical pump on the renal and circulatory function in patients with cirrhosis and recurrent or refractory ascites. The secondary objectives are the following:

• To evaluate the efficacy of treatment for handling ascites, associated with changes in the body weight of patients and their requirements for evacuation paracentesis during follow-up.
• To investigate the effects of treatment on bacterial translocation, by means of determining bacterial DNA.
• To determine the incidence of complications associated with treatment in the course of follow-up.
• To evaluate the effect of treatment on quality of life of the patients treated, evaluated in questionnaires entitled Short Form-36 and CLDQ (chronic liver disease questionnaire).

Study Overview

• Status: Unknown
• Conditions: Cirrhosis, Liver; Refractory Ascites
• Intervention / Treatment: Device: ALFApump system

• Study Type: Interventional
• Enrollment (Anticipated): 12
• Phase: Phase 2

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain, 08036
    • Hospital Clínic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Patients > 18 years of age
2. Cirrhosis of the liver defined by histological and/or clinical, analytical and radiological criteria.
3. Presenting refractory or recurrent ascites, requiring 2 or more evacuation paracentesis procedures over the last 3 months.
4. Written informed consent
5. Ability to comply with study procedures and ability to operate the device
6. Women of childbearing age should use adequate contraceptives

Exclusion Criteria:

1. Digestive haemorrhage over the last 7 days (these patients can be included once the 7-day period has gone by).
2. Kidney failure defined as serum creatinine higher than or equal to 2 mg/dl.
3. Serum bilirubin greater than 5 mg/dl.
4. Severe coagulopathy defined as platelet count of less than 40,000 or prothrombin time of less than 40%.
5. Recurring bacterial peritonitis, defined as 2 or more episodes over the last 6 months.
6. Recurring urinary infections, defined as 2 or more episodes over the last 6 months.
7. Clinical evidence of loculated ascites.
8. Advanced hepatocarcinoma, defined as one which exceeds Milan criteria.
9. Previous liver transplant.
10. Obstructive uropathy or any bladder anomaly which might contraindicate implantation of the device.
11. Pregnancy
12. Patients being in another clinical study that did not reach primary endpoint yet

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: ALFApump system implantation; Implantation of ALFApump system	Device: ALFApump system; The device described above will be implanted using general anaesthesia. The device will be programmed according to each patient's individual requirements, setting the daily loss of ascitic fluid needed to maintain a stable body weight.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The main aim of the study is to investigate the effect of treatment of ascites by the Sequana medical pump on the renal and circulatory function in patients with cirrhosis and recurrent or refractory ascites.	One month

Collaborators and Investigators

• Sponsor: Sequana Medical N.V.
• Investigators: Principal Investigator: Pere Gines, MD, Hospital Clinica Barcelona, Spain

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (ANTICIPATED): December 1, 2016
• Study Completion (ANTICIPATED): December 1, 2016

Study Registration Dates

• First Submitted: September 20, 2011
• First Submitted That Met QC Criteria: September 21, 2011
• First Posted (ESTIMATE): September 22, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): August 11, 2016
• Last Update Submitted That Met QC Criteria: August 10, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Liver Diseases; Fibrosis; Liver Cirrhosis; Ascites
• Other Study ID Numbers: 2011-AAR-003