Clinical and Biochemical Effects of Multipass Hemodialysis

Uremia Clinical Trial

— MHD  

Official title:

Clinical and Biochemical Effects of Multipass Hemodialysis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01267760
• Other study ID #: mhd1
• Status: Completed
• Phase: Phase 2
• First received: January 26, 2010
• Last updated: July 6, 2013
• Start date: March 2011
• Est. completion date: June 2011

Study information

• Verified date: July 2013
• Source: Herlev Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Regional Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Stable chronic HD patients

• Informed consent

Exclusion Criteria:

• Age <18 years

• Psychiatric disease

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Uremia

Intervention

Device:
• Multipass hemodialysis
8-hour dialysis using a recycled dialysis bath of 25-30 l

Locations

Country	Name	City	State
Denmark	Herlev Hospital	Herlev

Sponsors (2)

Lead Sponsor	Collaborator
Herlev Hospital	Flexdialysis ApS

Country where clinical trial is conducted

Denmark, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Urea Kt/V		9 hours	No
Secondary	Creatinine clearance		9 hours	No
Secondary	Patient symptoms		9 hours	No