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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01975025
Other study ID # 146/13
Secondary ID
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


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
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