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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified November 2013 by University Hospital Inselspital, Berne
Sponsor:
Collaborator:
Baxter Healthcare Corporation
Information provided by (Responsible Party):
University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier:
NCT01975025
First received: October 25, 2013
Last updated: November 5, 2013
Last verified: November 2013
  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
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: 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 ] [ Designated as safety issue: Yes ]

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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 16
Study Start Date: January 2014
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: June 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01975025

Locations
Switzerland
Dep. of Nephrology, Hypertension and Clinical Pharmacology, Bern University Hospital Not yet recruiting
Bern, Switzerland, 3010
Contact: Anna Christen, Study Coordinator    +41 (0)31 632 97 72    anna.christen@insel.ch   
Principal Investigator: Andreas Pasch, PD. Dr. med.         
Sponsors and Collaborators
University Hospital Inselspital, Berne
Baxter Healthcare Corporation
Investigators
Principal Investigator: Andreas Pasch, PD. Dr. med. University Clinic Inselspital Bern
  More Information

No publications provided

Responsible Party: University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier: NCT01975025     History of Changes
Other Study ID Numbers: 146/13
Study First Received: October 25, 2013
Last Updated: November 5, 2013
Health Authority: Switzerland: Ethikkommission

Keywords provided by University Hospital Inselspital, Berne:
Renal Dialysis

Additional relevant MeSH terms:
Anuria
Calcinosis
Kidney Diseases
Urologic Diseases
Urination Disorders
Calcium Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on July 29, 2014