Pilot Study of Wearable Artificial Kidney

Royal Free Hampstead NHS Trust8 enrolled

Overview

This is a pilot study of a wearable type of kidney dialysis machine to treat patients with chronic kidney disease.

This is a pilot study to evaluate the clearances, tolerability and safety of a wearable artificial kidney device for treating patients with chronic kidney failure.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Renal Failure

Interventions

Wearable artificial kidneyDEVICE

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * End stage renal failure * Regular haemodialysis * Cardiovascular stability * Stable vascular access Exclusion Criteria: * Allergy to heparin or ethylene oxide * Recent cardiovascular or neurological event * Unable to provide informed consent * Age \< 18

Locations (1)

UCL Center for Nephrology

London, London, United Kingdom

Outcomes

Primary Outcomes

urea, potassium, phosphate and B2M clearances

safety - cardiovascular,no hemolysis, bleeding, infection

no ammonia generation from sorbents, control of acid base balance

Secondary Outcomes

fluid removal

patient satisfaction questionnaire

affect of treatment of cytokines

Data from ClinicalTrials.gov

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