Effects of Treatment of Ascites by the ALFApump System on Renal and Circulatory Function
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 Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- 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. [ Time Frame: One month ] [ Designated as safety issue: No ]
|Study Start Date:||September 2011|
|Estimated Study Completion Date:||August 2014|
|Estimated Primary Completion Date:||August 2014 (Final data collection date for primary outcome measure)|
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.
Other Name: ALFApump system
Please refer to this study by its ClinicalTrials.gov identifier: NCT01438970
|Barcelona, Spain, 08036|
|Principal Investigator:||Pere Gines, MD||Hospital Clinica Barcelona, Spain|