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Pilot Study of Wearable Artificial Kidney

Phase 1
Completed
Conditions
Renal Failure
Registration Number
NCT00454974
Lead Sponsor
Royal Free Hampstead NHS Trust
Brief Summary

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

Detailed Description

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
8
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Primary Outcome Measures
NameTimeMethod
urea, potassium, phosphate and B2M clearances
safety - cardiovascular,no hemolysis, bleeding, infection
no ammonia generation from sorbents, control of acid base balance
Secondary Outcome Measures
NameTimeMethod
fluid removal
patient satisfaction questionnaire
affect of treatment of cytokines

Trial Locations

Locations (1)

UCL Center for Nephrology

🇬🇧

London, United Kingdom

UCL Center for Nephrology
🇬🇧London, United Kingdom

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