Hemodialysis Frequency and the Calcification Propensity of Serum

Hemodialysis Clinical Trial

— Intensified HD  

Official title:

Hemodialysis Frequency and the Calcification Propensity of Serum

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01975025
• Other study ID #: 146/13
• Status: Completed
• Phase: N/A
• First received: October 25, 2013
• Last updated: April 5, 2016
• Start date: June 2014
• Est. completion date: August 2014

Study information

• Verified date: April 2016
• Source: University Hospital Inselspital, Berne
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Chronic hemodialysis >3 months

• Anuria (<100ml urine per day)

• Written informed consent

Exclusion Criteria

• Citrate dialysis

• Significant fistula recirculation (>15%)

• Infection

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anuria
• Calcinosis
• Hemodialysis

Intervention

Procedure:
• Short daily dialysis for 2 weeks

Locations

Country	Name	City	State
Switzerland	Dep. of Nephrology, Hypertension and Clinical Pharmacology, Bern University Hospital	Bern

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital Inselspital, Berne	Baxter Healthcare Corporation

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline calcification propensity of serum		6 weeks	Yes
Secondary	Change from baseline of sodium, potassium, calcium, phosphate, magnesium, albumin, protein, hematocrit and their correlation with calcification propensity of serum		6 weeks	Yes