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The Carry Life UF device performs peritoneal ultrafiltration by adding a concentrated glucose to peritoneal dialysis fluid which has been instilled into the abdomen prior to the connection of the device. Maintaining the glucose concentration in the intraperitoneal fluid results in an increased fluid removal (ultrafiltration).
The clinical investigation will evaluate the ultrafiltration achieved with the Carry Life UF device compared to standard peritoneal dialysis (PD) therapy
Full description
A study of the peritoneal ultrafiltration achieved with Carry Life® UF compared to standard PD therapy, performed in 12 stable PD patients. The study consists of one baseline study session with Icodextrin overnight and one four-hour, 2.27% glucose exchange and three Carry Life® UF treatments with different glucose doses. All treatments are preceded by an Icodextrin dwell overnight.
Visit 1: The patient will be screened for study eligibility and a signed informed consent obtained before any of the study activities commence. Once included in the study the patient will be asked to document their ultrafiltration volumes for the week prior to the baseline study session (PD bags to be weighed before and after).
Visit 2: Baseline study session with standard PD therapy. The evening before visit 2 the patient will use Icodextrin 2000 ml overnight which is drained at the clinic before the start of the second PD exchange.
Visit 3, 4 and 5: Carry Life® UF study sessions The evening before the visits the patient will use Icodextrin 2000 ml overnight which is drained at the clinic the next day before the start of the Carry Life® UF study session.
Follow-up: Follow-up will be performed after the completion of the Carry Life® UF study sessions. The follow-up can either be performed at the clinic or by telephone which is at the discretion of the investigator and the patient.
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8 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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