Clinical and Biochemical Effects of Multipass Hemodialysis

NCT ID: NCT01267760

Last Updated: 2013-07-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2011-06-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Uremia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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conventional HD

conventional 4-hour HD

Group Type ACTIVE_COMPARATOR

Multipass hemodialysis

Intervention Type DEVICE

8-hour dialysis using a recycled dialysis bath of 25-30 l

Interventions

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Multipass hemodialysis

8-hour dialysis using a recycled dialysis bath of 25-30 l

Intervention Type DEVICE

Other Intervention Names

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dialysis hemodialysis dialysate

Eligibility Criteria

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Inclusion Criteria

* Stable chronic HD patients
* Informed consent

Exclusion Criteria

* Age \<18 years
* Psychiatric disease
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Flexdialysis ApS

UNKNOWN

Sponsor Role collaborator

Herlev Hospital

OTHER

Sponsor Role lead

Responsible Party

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James heaf

chief physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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James G Heaf, MD DMSc

Role: PRINCIPAL_INVESTIGATOR

Herlev Hospital

Locations

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Herlev Hospital

Herlev, Denmark, Denmark

Site Status

Countries

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Denmark

References

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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.

Reference Type RESULT
PMID: 23136214 (View on PubMed)

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.

Reference Type DERIVED
PMID: 25896788 (View on PubMed)

Other Identifiers

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mhd1

Identifier Type: -

Identifier Source: org_study_id

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