MHD: Clinical and Biochemical Effects of Multipass Hemodialysis

• Sponsor: Herlev Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT01267760
• Collaborator: Flexdialysis ApS (Other)
• Enrollment: 12
• Location: 1
• Arm: 1
• Duration (Months): 3
• Patients Per Site Per Month: 4

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Uremia	Device: Multipass hemodialysis	Phase 2

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 Design

• Study Type: Interventional
• Actual Enrollment: 12 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Clinical and Biochemical Effects of Multipass Hemodialysis
• Study Start Date: Mar 1, 2011
• Actual Primary Completion Date: Jun 1, 2011
• Actual Study Completion Date: Jun 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: conventional HD conventional 4-hour HD	Device: Multipass hemodialysis; 8-hour dialysis using a recycled dialysis bath of 25-30 l; Other Names: dialysis hemodialysis dialysate

Outcome Measures

Primary Outcome Measures

1. Urea Kt/V [9 hours]

Secondary Outcome Measures

1. Creatinine clearance [9 hours]

2. Patient symptoms [9 hours]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Stable chronic HD patients

• Informed consent

Exclusion Criteria:

• Age <18 years

• Psychiatric disease

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Herlev Hospital	Herlev		Denmark	2880

Sponsors and Collaborators

• Herlev Hospital
• Flexdialysis ApS

Investigators

• Principal Investigator: James G Heaf, MD DMSc, Herlev Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: James heaf, chief physician, Herlev Hospital
• ClinicalTrials.gov Identifier: NCT01267760
• Other Study ID Numbers: mhd1
• First Posted: Dec 28, 2010
• Last Update Posted: Jul 9, 2013
• Last Verified: Jul 1, 2013

• Keywords provided by James heaf, chief physician, Herlev Hospital: dialysis; hemodialysis; Effect of recycled low-volume dialysate on dialysis efficacy
• Additional relevant MeSH terms: Uremia; Dialysis Solutions

Study Results

No Results Posted as of Jul 9, 2013