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The Circadian Rhythm of Potassium and Cystatin C (Potassium)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01318746
First Posted: March 18, 2011
Last Update Posted: April 17, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Biotronik SE & Co. KG
Information provided by (Responsible Party):
University of Erlangen-Nürnberg Medical School
  Purpose
The potassium value is important to prevent cardiac arrhythmias and sudden cardiac death. In patients with renal failure, the potassium value is not stable and tends to raise. Until now there are no data available if the potassium value has a circadian rhythm and if there are individual changes from day to day.

Condition Intervention
Cardiac Arrhythmias Sudden Cardiac Death Procedure: Blood withdrawal

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: The Circadian Rhythm of Potassium and Cystatin c and the Day-to-day Variability

Resource links provided by NLM:


Further study details as provided by University of Erlangen-Nürnberg Medical School:

Primary Outcome Measures:
  • Potassium rhythm [ Time Frame: twice in 24 hours ]

    15 persons with normal renal function are hospitalized for 24 hours. Blood samples are taken every 2 hours in order to investigate the potassium value.

    It is repeated with 5 persons after 2 days, with 5 persons after 4 and with 5 persons after 6 days.



Secondary Outcome Measures:
  • Potassium value in renal failure [ Time Frame: twice in 24 hours ]
    15 persons with renal failure (GFR < 60 ml/min) are hospitalized for 24 hours. Blood samples are taken every 2 hours in order to investigate the potassium value It is repeated with 5 persons after 2 days, with 5 persons after 4 and with 5 persons after 6 days.


Enrollment: 30
Study Start Date: April 2011
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Healthy group
15 persons with normal renal function
Procedure: Blood withdrawal
blood withdrawal every 2 hours during 24 hours
Renal failure
15 persons with renal failure (GFR < 60 ml/min)
Procedure: Blood withdrawal
blood withdrawal every 2 hours during 24 hours

Detailed Description:
Potassium and cystatin c is measured every 2 hours during 24 hours, twice. There are two groups of patients: Patients with eGFR < 60 ml/min and patients with eGFR > 60 ml/min
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
healthy persons compared to patients with renal failure
Criteria

Inclusion Criteria:

  • at least 18 years old
  • normal renal function and impaired renal function (GFR < 60 ml/min) respectively

Exclusion Criteria:

  • pregnancy
  • anaemia (Hb<10 mg/dl)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01318746


Locations
Germany
Clinical Research Unit, Department of Nephrology and Hypertension, University of Erlangen-Nürnberg
Erlangen, Germany, 91054
Sponsors and Collaborators
University of Erlangen-Nürnberg Medical School
Biotronik SE & Co. KG
Investigators
Principal Investigator: Roland E. Schmieder, MD Department of Nephrology and Hypertension, University of Erlangen-Nürnberg Medical School
  More Information

Responsible Party: University of Erlangen-Nürnberg Medical School
ClinicalTrials.gov Identifier: NCT01318746     History of Changes
Other Study ID Numbers: 4408
First Submitted: March 17, 2011
First Posted: March 18, 2011
Last Update Posted: April 17, 2013
Last Verified: April 2013

Keywords provided by University of Erlangen-Nürnberg Medical School:
change of potassium amount, circadian and day-to-day variability

Additional relevant MeSH terms:
Death
Death, Sudden, Cardiac
Arrhythmias, Cardiac
Pathologic Processes
Heart Arrest
Heart Diseases
Cardiovascular Diseases
Death, Sudden
Cystatins
Cysteine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action