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Clinical and Biochemical Effects of Multipass Hemodialysis (MHD)

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. Identifier: NCT01267760
Recruitment Status : Completed
First Posted : December 28, 2010
Last Update Posted : July 9, 2013
Flexdialysis ApS
Information provided by (Responsible Party):
James heaf, Herlev Hospital

Brief Summary:
The purpose of this study is to investigate whether recycled dialysis fluid can supply enough clearance for hemodiaysis patients.

Condition or disease Intervention/treatment Phase
Uremia Device: Multipass hemodialysis Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical and Biochemical Effects of Multipass Hemodialysis
Study Start Date : March 2011
Actual Primary Completion Date : June 2011
Actual Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis

Arm Intervention/treatment
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

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

Secondary Outcome Measures :
  1. Creatinine clearance [ Time Frame: 9 hours ]
  2. Patient symptoms [ Time Frame: 9 hours ]

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Stable chronic HD patients
  • Informed consent

Exclusion Criteria:

  • Age <18 years
  • Psychiatric disease

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 identifier (NCT number): NCT01267760

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

Publications of Results:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: James heaf, chief physician, Herlev Hospital Identifier: NCT01267760    
Other Study ID Numbers: mhd1
First Posted: December 28, 2010    Key Record Dates
Last Update Posted: July 9, 2013
Last Verified: July 2013
Keywords provided by James heaf, Herlev Hospital:
Effect of recycled low-volume dialysate on dialysis efficacy
Additional relevant MeSH terms:
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Kidney Diseases
Urologic Diseases
Dialysis Solutions
Pharmaceutical Solutions