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Clinical and Biochemical Effects of Multipass Hemodialysis (MHD)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01267760
First Posted: December 28, 2010
Last Update Posted: July 9, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Flexdialysis ApS
Information provided by (Responsible Party):
James heaf, Herlev Hospital
  Purpose
The purpose of this study is to investigate whether recycled dialysis fluid can supply enough clearance for hemodiaysis patients.

Condition Intervention Phase
Uremia Device: Multipass hemodialysis Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical and Biochemical Effects of Multipass Hemodialysis

Resource links provided by NLM:


Further study details as provided by James heaf, Herlev Hospital:

Primary Outcome Measures:
  • Urea Kt/V [ Time Frame: 9 hours ]

Secondary Outcome Measures:
  • Creatinine clearance [ Time Frame: 9 hours ]
  • Patient symptoms [ Time Frame: 9 hours ]

Enrollment: 12
Study Start Date: March 2011
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: conventional HD
conventional 4-hour HD
Device: Multipass hemodialysis
8-hour dialysis using a recycled dialysis bath of 25-30 l
Other Names:
  • dialysis
  • hemodialysis
  • dialysate

Detailed Description:

Conventional hemodialysis uses large amounts of water, which hinders travel possibilies for home hemodialysis (HD) patients. We have developed a recycling system using 25-30 l dialysate per dialysis. In vitro investigations show that this results in adequate dialysis.

12 HD patients will be studied during two dialysis sessions. The first HD will be a conventional 4 hour dialysis, using single pass dialysate. The second will be an 8-hour HD using multipass (recycled) dialysate 25-30 l. Clearance of urea, creatinine, phosphate and cobalamin will be measured both in the patient and the dialysate. Patient symptoms will be recorded.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Stable chronic HD patients
  • Informed consent

Exclusion Criteria:

  • Age <18 years
  • Psychiatric disease
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01267760


Locations
Denmark
Herlev Hospital
Herlev, Denmark, 2880
Sponsors and Collaborators
Herlev Hospital
Flexdialysis ApS
Investigators
Principal Investigator: James G Heaf, MD DMSc Herlev Hospital
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: James heaf, chief physician, Herlev Hospital
ClinicalTrials.gov Identifier: NCT01267760     History of Changes
Other Study ID Numbers: mhd1
First Submitted: January 26, 2010
First Posted: December 28, 2010
Last Update Posted: July 9, 2013
Last Verified: July 2013

Keywords provided by James heaf, Herlev Hospital:
dialysis
hemodialysis
Effect of recycled low-volume dialysate on dialysis efficacy

Additional relevant MeSH terms:
Dialysis Solutions
Pharmaceutical Solutions