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

Primary Purpose

Hemodialysis, Anuria

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Short daily dialysis for 2 weeks
Sponsored by
Insel Gruppe AG, University Hospital Bern
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hemodialysis focused on measuring Renal Dialysis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria

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

Sites / Locations

  • Dep. of Nephrology, Hypertension and Clinical Pharmacology, Bern University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

All study participants

Arm Description

Short daily dialysis for 2 weeks

Outcomes

Primary Outcome Measures

Change from baseline calcification propensity of serum

Secondary Outcome Measures

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

Full Information

First Posted
October 25, 2013
Last Updated
April 5, 2016
Sponsor
Insel Gruppe AG, University Hospital Bern
Collaborators
Baxter Healthcare Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT01975025
Brief Title
Hemodialysis Frequency and the Calcification Propensity of Serum
Acronym
Intensified HD
Official Title
Hemodialysis Frequency and the Calcification Propensity of Serum
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
June 2014 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
August 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Insel Gruppe AG, University Hospital Bern
Collaborators
Baxter Healthcare Corporation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemodialysis, Anuria
Keywords
Renal Dialysis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
All study participants
Arm Type
Experimental
Arm Description
Short daily dialysis for 2 weeks
Intervention Type
Procedure
Intervention Name(s)
Short daily dialysis for 2 weeks
Primary Outcome Measure Information:
Title
Change from baseline calcification propensity of serum
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Change from baseline of sodium, potassium, calcium, phosphate, magnesium, albumin, protein, hematocrit and their correlation with calcification propensity of serum
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Chronic hemodialysis >3 months Anuria (<100ml urine per day) Written informed consent Exclusion Criteria Citrate dialysis Significant fistula recirculation (>15%) Infection
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andreas Pasch, PD. Dr. med.
Organizational Affiliation
University Clinic Inselspital Bern
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dep. of Nephrology, Hypertension and Clinical Pharmacology, Bern University Hospital
City
Bern
ZIP/Postal Code
3010
Country
Switzerland

12. IPD Sharing Statement

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Hemodialysis Frequency and the Calcification Propensity of Serum

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