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Clinical and Biochemical Effects of Multipass Hemodialysis (MHD)

Primary Purpose

Uremia

Status
Completed
Phase
Phase 2
Locations
Denmark
Study Type
Interventional
Intervention
Multipass hemodialysis
Sponsored by
Herlev Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Uremia focused on measuring dialysis, hemodialysis, Effect of recycled low-volume dialysate on dialysis efficacy

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Stable chronic HD patients
  • Informed consent

Exclusion Criteria:

  • Age <18 years
  • Psychiatric disease

Sites / Locations

  • Herlev Hospital

Arms of the Study

Arm 1

Arm Type

Active Comparator

Arm Label

conventional HD

Arm Description

conventional 4-hour HD

Outcomes

Primary Outcome Measures

Urea Kt/V

Secondary Outcome Measures

Creatinine clearance
Patient symptoms

Full Information

First Posted
January 26, 2010
Last Updated
July 6, 2013
Sponsor
Herlev Hospital
Collaborators
Flexdialysis ApS
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1. Study Identification

Unique Protocol Identification Number
NCT01267760
Brief Title
Clinical and Biochemical Effects of Multipass Hemodialysis
Acronym
MHD
Official Title
Clinical and Biochemical Effects of Multipass Hemodialysis
Study Type
Interventional

2. Study Status

Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Herlev Hospital
Collaborators
Flexdialysis ApS

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uremia
Keywords
dialysis, hemodialysis, Effect of recycled low-volume dialysate on dialysis efficacy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
conventional HD
Arm Type
Active Comparator
Arm Description
conventional 4-hour HD
Intervention Type
Device
Intervention Name(s)
Multipass hemodialysis
Other Intervention Name(s)
dialysis, hemodialysis, dialysate
Intervention Description
8-hour dialysis using a recycled dialysis bath of 25-30 l
Primary Outcome Measure Information:
Title
Urea Kt/V
Time Frame
9 hours
Secondary Outcome Measure Information:
Title
Creatinine clearance
Time Frame
9 hours
Title
Patient symptoms
Time Frame
9 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Stable chronic HD patients Informed consent Exclusion Criteria: Age <18 years Psychiatric disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James G Heaf, MD DMSc
Organizational Affiliation
Herlev Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Herlev Hospital
City
Herlev
ZIP/Postal Code
2880
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
23136214
Citation
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.
Results Reference
result
PubMed Identifier
25896788
Citation
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.
Results Reference
derived

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Clinical and Biochemical Effects of Multipass Hemodialysis

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