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

This study is currently recruiting participants.
Verified January 2013 by Sequana Medical AG
Sponsor:
Information provided by (Responsible Party):
Sequana Medical AG
ClinicalTrials.gov Identifier:
NCT01438970
First received: September 20, 2011
Last updated: January 29, 2013
Last verified: January 2013
History of Changes

September 20, 2011
January 29, 2013
September 2011
August 2013   (final data collection date for primary outcome 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. [ Time Frame: One month ] [ Designated as safety issue: No ]
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 ]

Assessments will be done at:

  • preimplant
  • day 2, 3, 5 and 7 predischarge
  • day 14 postimplant
  • day 21 postimplant
  • day 30 postimplant
Complete list of historical versions of study NCT01438970 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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).
Not Provided
Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Liver Cirrhosis
  • Ascites
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
ALFApump system implantation
Implantation of ALFApump system
Intervention: Device: ALFApump system
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
12
August 2014
August 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Pere Gines, MD (+34) 93 227 1713 PGINES@clinic.ub.es
Spain
 
NCT01438970
2011-AAR-003
No
Sequana Medical AG
Sequana Medical AG
Not Provided
Principal Investigator: Pere Gines, MD Hospital Clinica Barcelona, Spain
Sequana Medical AG
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP