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

Cirrhosis, Liver Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01438970
• Other study ID #: 2011-AAR-003
• Status: Active, not recruiting
• Phase: Phase 2
• First received: September 20, 2011
• Last updated: August 10, 2016
• Start date: September 2011
• Est. completion date: December 2016

Study information

• Verified date: August 2016
• Source: Sequana Medical AG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Agencia Española de Medicamentos y Productos SanitariosSpain: Departament de Salut de la Generalitat de CatalunyaSpain: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 12
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ascites
• Cirrhosis, Liver
• Fibrosis
• Liver Cirrhosis
• Refractory Ascites

Intervention

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.

Locations

Country	Name	City	State
Spain	Hospital clinic	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Sequana Medical AG

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No