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: July 6, 2013
Last verified: July 2013
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Publications:
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: July 6, 2013
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 July 24, 2014