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 (every month) 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.
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 (every 2 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. The primary objective of the study is to assess 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. This would potentially guide the clinical use of the alfapump system. The secondary objectives of the study are to address the objectives of a previous alfa pump study /sub study, to allow comparison of the proposed study data to that generated in the previous studies. These will be measured at the 1-month and 3-month time points.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
Implantation of alfapump
Patients implanted with an alfapump will receive intermittent salt-poor human albumin solution
Royal Free Hospital
London, United Kingdom
To assess whether intermittent human albumin replacement in accordance with large volume paracentesis guidelines (8g/L ascites drained) can prevent the development of renal dysfunction, measured by serum creatinine
Measured by serum creatinine.
Time frame: 3 months
Assessment of circulatory haemodynamics, measured by non-invasive cardiac haemodynamics
Measured by non-invasive cardiac haemodynamics
Time frame: 3 months
Assessment of cirrhosis- related complications, measured by Incidence of specific cirrhosis-related complications
Measured by Incidence of specific cirrhosis-related complications
Time frame: 3 months
Assessment of the Overall Survival at 3 months, measured by survival
Measured by overall survival at 3 months
Time frame: 3 months
Assessment of impact on nutrition, measured by changes in body weight
Measured by changes in the nutritional status of the patient
Time frame: 3 months
Assessment of impact on nutrition, measured by changes in circumference of arm
Measured by changes in the nutritional status of the patient
Time frame: 3 months
Assessment of impact on nutrition, measured by changes in tricipital skinfold
Measured by changes in the nutritional status of the patient
Time frame: 3 months
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Assessment of impact on nutrition, measured by changes in handgrip
Measured by changes in the nutritional status of the patient
Time frame: 3 months
Assessment of the need for large volume paracentesis, measured by the overall requirements of paracentesis
Measured by the overall requirement for paracentesis
Time frame: 3 months
Assessment of impact on Systemic Inflammatory Response, measured by CRP
Measured by Inflammatory markers
Time frame: 3 months
Assessment of impact on Systemic Inflammatory Response, measured by cytokines
Measured by Inflammatory markers
Time frame: 3 months
Assessment of impact on Systemic Inflammatory Response, measured by function of the peripheral blood mononuclear cells
Measured by Inflammatory markers
Time frame: 3 months
Assessment of levels of bacterial DNA in serum, measured by presence of bacterial DNA in blood
Measured by the presence of bacterial DNA in blood.
Time frame: 3 months