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Completed

NCT Number: NCT01975025

Hemodialysis Frequency and the Calcification Propensity of Serum

The aim of this clinical research project is to test the hypothesis that daily dialysis has favorable effects on the calcification propensity of human serum, when determined by the investigators' newly developed in vitro serum test. The investigators' hypothesis is that shorter interdialytic intervals will result in an improved calcification propensity of serum. The determination of serum calcification has the potential to become a novel measure of dialysis quality in the future.

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Key information

Conditions

Hemodialysis Anuria Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Urination Disorders Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dep. of Nephrology, Hypertension and Clinical Pharmacology, Bern University Hospital

Bern, Canton of Bern, 3010, Switzerland

About this study

Background

The serum calcification test has been established and validated by A. Pasch and coworkers, the expertise to perform the necessary statistical analyses is present in the investigator's department, all patient-related procedures necessary for this project are routinely performed in the investigator's department.

Objective

Does short daily hemodialysis strengthen the calcification-inhibitory forces inherent in hemodialysis patient sera, when compared to conventional three-times weekly hemodialysis?

Methods

Serum calcification test

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Chronic hemodialysis >3 months
  • Anuria (<100ml urine per day)
  • Written informed consent

Exclusion criteria

  • Citrate dialysis
  • Significant fistula recirculation (>15%)
  • Infection

Treatment and study plan

Short daily dialysis for 2 weeks

Procedure

Primary outcomes

  1. Change from baseline calcification propensity of serum

    Time frame: 6 weeks

Secondary outcomes

  1. Change from baseline of sodium, potassium, calcium, phosphate, magnesium, albumin, protein, hematocrit and their correlation with calcification propensity of serum

    Time frame: 6 weeks

Sponsors and collaborators

Lead sponsor

Insel Gruppe AG, University Hospital Bern

Other

Collaborators

  • Baxter Healthcare Corporation

Registry information

Acronym: Intensified HD

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Nov 4, 2013
Registry last updated
Apr 6, 2016

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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