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Completed

NCT Number: NCT01267760

Clinical and Biochemical Effects of Multipass Hemodialysis

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

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Key information

Conditions

Uremia Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Urogenital Diseases Urologic Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Herlev Hospital

Herlev, Denmark, 2880

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Stable chronic HD patients
  • Informed consent

Exclusion criteria

  • Age <18 years
  • Psychiatric disease

Treatment and study plan

Multipass hemodialysis

Device

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

Other names: dialysis, hemodialysis, dialysate

Primary outcomes

  1. Urea Kt/V

    Time frame: 9 hours

Secondary outcomes

  1. Creatinine clearance

    Time frame: 9 hours

  2. Patient symptoms

    Time frame: 9 hours

Sponsors and collaborators

Lead sponsor

Herlev Hospital

Other

Collaborators

  • Flexdialysis ApS

Registry information

Acronym: MHD

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Dec 28, 2010
Registry last updated
Jul 9, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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