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Clinical and Biochemical Effects of Multipass Hemodialysis (MHD)

This study has been completed.
Sponsor:
Collaborator:
Flexdialysis ApS
Information provided by (Responsible Party):
James heaf, Herlev Hospital
ClinicalTrials.gov Identifier:
NCT01267760
First received: January 26, 2010
Last updated: September 17, 2012
Last verified: September 2012
History of Changes
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Clinical and Biochemical Effects of Multipass Hemodialysis

Resource links provided by NLM:

MedlinePlus related topics: Dialysis
U.S. FDA Resources

Further study details as provided by Herlev Hospital:

Primary Outcome Measures:
  • Urea Kt/V [ Time Frame: 9 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Creatinine clearance [ Time Frame: 9 hours ] [ Designated as safety issue: No ]
  • Patient symptoms [ Time Frame: 9 hours ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Stable chronic HD patients
  • Informed consent

Exclusion Criteria:

  • Age <18 years
  • Psychiatric disease
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: James heaf, chief physician, Herlev Hospital
ClinicalTrials.gov Identifier: NCT01267760     History of Changes
Other Study ID Numbers: mhd1
Study First Received: January 26, 2010
Last Updated: September 17, 2012
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics

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

Additional relevant MeSH terms:
Uremia
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on May 23, 2013