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Hemodialysis Frequency and the Calcification Propensity of Serum (Intensified HD)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01975025
First Posted: November 4, 2013
Last Update Posted: April 6, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Baxter Healthcare Corporation
Information provided by (Responsible Party):
University Hospital Inselspital, Berne
  Purpose
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.

Condition Intervention
Hemodialysis Anuria Procedure: Short daily dialysis for 2 weeks

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Hemodialysis Frequency and the Calcification Propensity of Serum

Resource links provided by NLM:


Further study details as provided by University Hospital Inselspital, Berne:

Primary Outcome Measures:
  • Change from baseline calcification propensity of serum [ Time Frame: 6 weeks ]

Secondary Outcome Measures:
  • Change from baseline of sodium, potassium, calcium, phosphate, magnesium, albumin, protein, hematocrit and their correlation with calcification propensity of serum [ Time Frame: 6 weeks ]

Enrollment: 17
Study Start Date: June 2014
Study Completion Date: August 2014
Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: All study participants
Short daily dialysis for 2 weeks
Procedure: Short daily dialysis for 2 weeks

Detailed Description:

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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria

  • Citrate dialysis
  • Significant fistula recirculation (>15%)
  • Infection
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01975025


Locations
Switzerland
Dep. of Nephrology, Hypertension and Clinical Pharmacology, Bern University Hospital
Bern, Switzerland, 3010
Sponsors and Collaborators
University Hospital Inselspital, Berne
Baxter Healthcare Corporation
Investigators
Principal Investigator: Andreas Pasch, PD. Dr. med. University Clinic Inselspital Bern
  More Information

Responsible Party: University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier: NCT01975025     History of Changes
Other Study ID Numbers: 146/13
First Submitted: October 25, 2013
First Posted: November 4, 2013
Last Update Posted: April 6, 2016
Last Verified: April 2016

Keywords provided by University Hospital Inselspital, Berne:
Renal Dialysis

Additional relevant MeSH terms:
Calcinosis
Calcium Metabolism Disorders
Metabolic Diseases