NCT01975025

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 25, 2013

Completed
10 days until next milestone

First Posted

Study publicly available on registry

November 4, 2013

Completed
7 months until next milestone

Study Start

First participant enrolled

June 1, 2014

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
Last Updated

April 6, 2016

Status Verified

April 1, 2016

Enrollment Period

2 months

First QC Date

October 25, 2013

Last Update Submit

April 5, 2016

Conditions

HemodialysisAnuria

Keywords

Renal Dialysis

Outcome Measures

Primary Outcomes (1)

  • Change from baseline calcification propensity of serum

    6 weeks

Secondary Outcomes (1)

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

    6 weeks

Study Arms (1)

All study participants

EXPERIMENTAL

Short daily dialysis for 2 weeks

Procedure: Short daily dialysis for 2 weeks

Interventions

Short daily dialysis for 2 weeksPROCEDURE
All study participants

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Bern, Canton of Bern, 3010, Switzerland

Location

MeSH Terms

Conditions

Anuria

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrination DisordersMale Urogenital Diseases

Study Officials

  • Andreas Pasch, PD. Dr. med.

    University Clinic Inselspital Bern

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 25, 2013

First Posted

November 4, 2013

Study Start

June 1, 2014

Primary Completion

August 1, 2014

Study Completion

August 1, 2014

Last Updated

April 6, 2016

Record last verified: 2016-04

Locations

CH(1)