HemodialysisIntensified HDNCT01975025
Hemodialysis Frequency and the Calcification Propensity of Serum
A study testing Short daily dialysis for 2 weeks in people with Hemodialysis and Anuria, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemodialysis, Anuria
- What is being tested?
- Short daily dialysis for 2 weeks
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jun 2014to Aug 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic hemodialysis >3 months
- Anuria (<100ml urine per day)
- Written informed consent
Who cannot join
- Citrate dialysis
- Significant fistula recirculation (>15%)
- Infection
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Dep. of Nephrology, Hypertension and Clinical Pharmacology, Bern University Hospital
Bern, Canton of Bern, 3010
About this study
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.
Read the 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
- Conditions
- Hemodialysis, Anuria
- Being tested
- Short daily dialysis for 2 weeks
- Keywords
- Renal Dialysis
- Medical subject headings
- Anuria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Short daily dialysis for 2 weeksProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| All study participants | Experimental | Short daily dialysis for 2 weeks Receives: Procedure: Short daily dialysis for 2 weeks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline calcification propensity of serum
Measured: 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
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2013 (estimated)
- Study startJun 2014
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemodialysisStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Collaborators
- Baxter Healthcare Corporation
- Responsible party
- Sponsor
- Investigators
- Andreas Pasch, PD. Dr. med., Principal investigator, University Clinic Inselspital Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01975025
- Sponsor's protocol ID
- 146/13
- Acronym
- Intensified HD
- Status last verified
- Apr 2016
- First submitted
- 25 Oct 2013
- Last updated
- 6 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hemodialysis Frequency and the Calcification Propensity of Serum
- ClinicalTrials.gov ID
- NCT01975025
- Acronym / sponsor ID
- Intensified HD / 146/13
- Conditions
- Hemodialysis, Anuria
- Keywords
- Renal Dialysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Collaborators
- Baxter Healthcare Corporation
- Study start
- Jun 2014
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 4 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All study participants | Experimental | Procedure: Short daily dialysis for 2 weeksShort daily dialysis for 2 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Chronic hemodialysis >3 months
- Anuria (<100ml urine per day)
- Written informed consent
Key exclusion criteria (3 listed)
- Citrate dialysis
- Significant fistula recirculation (>15%)
- Infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Short daily dialysis for 2 weeks | Procedure or surgery | All study participants |
Primary outcome
Change from baseline calcification propensity of serum
Time frame: 6 weeks
1 secondary outcome
Change from baseline of sodium, potassium, calcium, phosphate, magnesium, albumin, protein, hematocrit and their correlation with calcification propensity of serum
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andreas Pasch, PD. Dr. med. principal investigator
University Clinic Inselspital Bern
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Short daily dialysis for 2 weeks in people with Hemodialysis and Anuria, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline calcification propensity of serum (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2016.