Clinical and Biochemical Effects of Multipass Hemodialysis | NCT01267760

Studies
Clinical and Biochemical Effects of Multipass Hemodialysis

NCT01267760

Sponsor

Herlev Hospital

Status

Completed

Last Update Posted

Jul 9, 2013Estimated

Enrollment

12Actual

Phase

Phase 2

Conditions

Uremia

Interventions

Multipass hemodialysis

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2011

Primary Completion Date

Jun 2011Actual

Completion Date

Jun 2011Actual

First Submitted Date

Jan 26, 2010

First Submission Date that Met QC Criteria

Dec 27, 2010

First Posted Date

Dec 28, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 6, 2013

Last Update Posted Date

Jul 9, 2013Estimated

Name	Class
Flexdialysis ApS	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

12Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
conventional HD	Active Comparator	conventional 4-hour HD	Device: Multipass hemodialysis

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Multipass hemodialysis	Device	8-hour dialysis using a recycled dialysis bath of 25-30 l	conventional HD

Measure	Description	Time Frame
Urea Kt/V		9 hours

Measure	Description	Time Frame
Creatinine clearance		9 hours
Patient symptoms		9 hours

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Stable chronic HD patients
Informed consent

Exclusion Criteria:

Age <18 years
Psychiatric disease

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
James G Heaf, MD DMSc	Herlev Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Herlev Hospital		Herlev	Denmark	2880	Denmark

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
23136214	Result	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.
25896788	Derived	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.

ID	Term
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications

ID	Term
D003956	Dialysis
D006435	Renal Dialysis

ID	Term
D002623	Chemistry Techniques, Analytical
D008919	Investigative Techniques
D055598	Chemical Phenomena
D017582	Renal Replacement Therapy