Pilot Study to Investigate the Effects of Increased Dialysate Magnesium and Dialysate Bicarbonate on the Calcification Propensity of Serum
NCT ID: NCT02621762
Last Updated: 2017-09-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
12 participants
INTERVENTIONAL
2015-12-31
2016-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Mg first
Receives MgCl2 first, MgCl2 and Bicarbonate in second phase
Magnesium
Magnesium in dialysate increased
Bicarbonate
Bicarbonate in dialysate increased
Bicarbonate first
Receives Bicarbonate first, MgCl2 and Bicarbonate in second phase
Magnesium
Magnesium in dialysate increased
Bicarbonate
Bicarbonate in dialysate increased
Interventions
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Magnesium
Magnesium in dialysate increased
Bicarbonate
Bicarbonate in dialysate increased
Eligibility Criteria
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Inclusion Criteria
* Negative pregnancy test of female patients in child-bearing age
* The patients have to be able to understand the character and the individual impact of the clinical study and they have to give written informed consent to participate in the study
* Start of chronic hemodialysis treatment ≥ 3 months ago
* HCO3- in venous plasma ≤23 mmol/L before the start of the last dialysis of the week
* Magnesium in venous plasma ≤ 1.45 mmol/L before the start of the first dialysis of the week
* T50 ≥ 200 minutes.
Exclusion Criteria
* History of alcohol abuse, illicit drug use, significant mental illness, physical dependence to any opioid, or any history of drug abuse or addiction within 12 months of study enrolment
18 Years
111 Years
ALL
No
Sponsors
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Insel Gruppe AG, University Hospital Bern
OTHER
Responsible Party
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Principal Investigators
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Dominik Uehlinger, Prof Dr.med.
Role: PRINCIPAL_INVESTIGATOR
Insel Gruppe AG, University Hospital Bern
Locations
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University Hospital Bern Inselspital
Bern, Canton of Bern, Switzerland
Countries
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References
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Pasch A, Farese S, Graber S, Wald J, Richtering W, Floege J, Jahnen-Dechent W. Nanoparticle-based test measures overall propensity for calcification in serum. J Am Soc Nephrol. 2012 Oct;23(10):1744-52. doi: 10.1681/ASN.2012030240. Epub 2012 Sep 6.
Other Identifiers
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293_15
Identifier Type: -
Identifier Source: org_study_id