Clinical trial NCT01438970: Effects of Treatment of Ascites by the ALFApump System on Renal and Circulatory Function
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Cirrhosis, Liver
Refractory Ascites
Lead sponsor: Sequana Medical N.V.
Sponsor class: INDUSTRY
First posted: 2011-09-22
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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).


Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: One month
Secondary outcomes:
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital clinic
Study officials:
affiliation: Hospital Clinica Barcelona, Spain
name: Pere Gines, MD
role: PRINCIPAL_INVESTIGATOR
References: