Hemodialysis Frequency and the Calcification Propensity of Serum

Not Applicable

Completed

• Conditions: Hemodialysis; Anuria
• Interventions: Procedure: Short daily dialysis for 2 weeks

• Registration Number: NCT01975025
• Lead Sponsor: Insel Gruppe AG, University Hospital Bern

Brief Summary

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.

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

Study Timeline

• Study First Submitted: 2013-10-25
• Study First Submitted QC: 2013-11-01
• Study First Posted: 2013-11-03
• Study Start: 2014-06
• Primary Completion: 2014-08
• Study Completion: 2014-08
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-05
• Last Update Posted: 2016-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

Inclusion Criteria

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

Exclusion Criteria

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
All study participants	Short daily dialysis for 2 weeks	Short daily dialysis for 2 weeks

Primary Outcome Measures

Name	Time	Method
Change from baseline calcification propensity of serum	6 weeks

Secondary Outcome Measures

Name	Time	Method
Change from baseline of sodium, potassium, calcium, phosphate, magnesium, albumin, protein, hematocrit and their correlation with calcification propensity of serum	6 weeks

Trial Locations

Locations (1)

Dep. of Nephrology, Hypertension and Clinical Pharmacology, Bern University Hospital; 🇨🇭 Bern, Switzerland