- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01267760
Clinical and Biochemical Effects of Multipass Hemodialysis (MHD)
Study Overview
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
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Herlev, Denmark, 2880
- Herlev Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Stable chronic HD patients
- Informed consent
Exclusion Criteria:
- Age <18 years
- Psychiatric disease
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: conventional HD
conventional 4-hour HD
|
8-hour dialysis using a recycled dialysis bath of 25-30 l
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Urea Kt/V
Time Frame: 9 hours
|
9 hours
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Creatinine clearance
Time Frame: 9 hours
|
9 hours
|
Patient symptoms
Time Frame: 9 hours
|
9 hours
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
General Publications
- Heaf JG, Axelsen M, Pedersen RS. Multipass haemodialysis: a novel dialysis modality. Nephrol Dial Transplant. 2013 May;28(5):1255-64. doi: 10.1093/ndt/gfs484. Epub 2012 Nov 7.
- Eloot S, Van Biesen W, Axelsen M, Glorieux G, Pedersen RS, Heaf JG. Protein-bound solute removal during extended multipass versus standard hemodialysis. BMC Nephrol. 2015 Apr 18;16:57. doi: 10.1186/s12882-015-0056-y.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- mhd1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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