The purpose of this study is to demonstrate the safety of dialysate regeneration of the PAK HD sorbent cartridge and therapy efficacy of the PAK HD sorbent therapy compared with conventional hemodialysis.
This clinical trial is being conducted to evaluate the biochemical safety of dialysate regeneration with the PAK HD sorbent cartridge in a limited number of patients and treatments. Therapy efficacy of the PAK HD sorbent therapy will be compared to conventional hemodialysis under the same therapy settings. The trial will use only one single PAK HD sorbent therapy per patient, and a total of 3 patients. The PAK HD therapies will be performed in the middle of the week.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Enrollment
3
Study Period 1: Subjects will receive their normal prescribed 4h CHD treatments Monday or Tuesday. On Wednesday or Thursday, one 4h CHD therapy will be performed at a dialysate flow rate (QD) of 300mL/min, identical to the dialysate flow rate of the PAK HD sorbent therapy. Blood and dialysate samples will be collected during treatment and sent for analysis, for comparison with PAK HD sorbent treatment. Study Period 2: Subjects will again receive their normal prescribed 4h CHD treatments Monday or Tuesday. On Wednesday or Thursday, a 2h PAK HD +/- 2h CHD therapy will be performed. Blood and dialysate samples will again be collected during treatment and sent for analysis, for comparison with the CHD therapy of the first period. After completion of study period 2 (PAK HD +/- CHD), subjects will be observed for a minimum duration of 1 h in the hospital after which they may go home if the post-dialysis period was uneventful.
National University Hospital Investigational Medicine Unit
Singapore, Singapore
The primary objective of this early feasibility clinical trial is to assess the (short term) clinical safety of the PAK HD sorbent treatment in a limited number of patients and treatments.
The clinical safety of the PAK HD will be evaluated in terms of the following primary endpoints: 1. Absence of serious adverse events (SAE) 2. Absence of critical change in patient's clinical condition and vital parameters (Blood pressure, heart rate, body temperature and respiratory rate and pulse oximetry) during treatment. 3. Absence of critical change in haematology and biochemistry immediately before the start of therapy and immediately after completion of therapy, including acid-base state, electrolytes, and ammonia.
Time frame: 2 weeks
The secondary objective of this study is to evaluate the efficacy of the PAK HD therapy in comparison to CHD, in terms of uremic toxin removal efficacy (urea, creatinine and phosphate).
The therapy efficacy will be evaluated with the secondary endpoint: a) PAK HD therapy provides equivalent toxin clearances for urea, phosphate and creatinine as compared to CHD
Time frame: 2 weeks
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