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The Circadian Rhythm of Potassium and Cystatin C

This study has been completed.
Sponsor:
Collaborator:
Biotronik SE & Co. KG
Information provided by (Responsible Party):
University of Erlangen-Nürnberg Medical School
ClinicalTrials.gov Identifier:
NCT01318746
First received: March 17, 2011
Last updated: April 16, 2013
Last verified: April 2013
History of Changes
  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:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Potassium rhythm [ Time Frame: twice in 24 hours ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: University of Erlangen-Nürnberg Medical School
ClinicalTrials.gov Identifier: NCT01318746     History of Changes
Other Study ID Numbers: 4408
Study First Received: March 17, 2011
Last Updated: April 16, 2013
Health Authority: Germany: Ethics Commission

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

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

ClinicalTrials.gov processed this record on May 16, 2013