2015-AAR-009 Alfapump-albumin replacament therapy V1.0
Research type
Research Study
Full title
Study into the effects of albumin replacement therapy on renal and circulatory function in patients implanted with the alfapump
IRAS ID
173810
Contact name
Rajiv Jalan
Contact email
Sponsor organisation
Sequana Medical
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 10 months, 31 days
Research summary
The study will be a single centre, open-label trial. The patients will have a diagnosis of refractory ascites and will meet specified inclusion/exclusion criteria Informed consent will be obtained from all patients. All patients will have an alfapump surgically inserted and in addition will receive 8g of salt-poor Human Albumin Solution (20%) per 1 litre of Ascites drained. This Intravenous administration will be intermittent (every2 weeks) and will take place as a day patient. Patients will also receive standard of care, which may include, but is not limited to, administration of diuretics, paracentesis and consideration for orthotopic liver transplantation. All patients will receive gut sterilization with Ciprofloxacin,750mg/once weekly or Norfloxacin 400mg/day starting prior to Day 0 as prophylaxis against spontaneous bacterial peritonitis (SBP).Primary prophylaxis with the above antibiotics would be continued if the ascitic fluid protein is less than 15g/l.A standard diet including controlled salt intake will also be required throughout the study. The alfapump System will be implanted using general anaesthesia using the procedure described above. The parameters of the device will be modified according to each patient's individual requirements, setting the daily loss of ascetic fluid needed to maintain a stable body weight.The alfapump System is a device implanted at subcutaneous level with a rechargeable battery which, via two catheters, is able to move the ascitic fluid from the peritoneal cavity to the bladder so the liquid can be eliminated by normal urination.This study was designed to evaluate whether intermittent human albumin replacement in accordance with large volume paracentesis guidelines (8g/L ascites drained) can prevent the development of renal dysfunction at the 3-month assessment. The alfapump system is CE marked and will be used within its CE-marked intended use.Following informed consent, eligible patients with refractory ascites receive the alfapump device. All patients will be monitored for safety throughout the study by medical examinations, blood and urine tests and observation of adverse events. The study will last for approximately 10 months to allow for adequate patient recruitment and to complete a 3 month follow up phase for each patient. Patients will be hospitalized approximately 48 hours before planned surgery. All of the patients will be discharged at investigator’s discretion, when their clinical status allows is. The patients may attend the hospital daily as required for the first 4 days postimplant, at day 7, then at two-weekly intervals over the first month. After the first month the visits will be monthly until completion at 3 months. When the study comes to an end the patients will remain implanted.
REC name
East of England - Cambridgeshire and Hertfordshire Research Ethics Committee
REC reference
15/EE/0220
Date of REC Opinion
11 Aug 2015
REC opinion
Further Information Favourable Opinion