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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

March 17, 2011
April 16, 2013
April 2011
April 2013   (final data collection date for primary outcome measure)
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.

Same as current
Complete list of historical versions of study NCT01318746 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
The Circadian Rhythm of Potassium and Cystatin C
The Circadian Rhythm of Potassium and Cystatin c and the Day-to-day Variability

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.

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

Observational
Observational Model: Cohort
Time Perspective: Cross-Sectional
Not Provided
Not Provided
Non-Probability Sample

healthy persons compared to patients with renal failure

  • Cardiac Arrhythmias
  • Sudden Cardiac Death
Procedure: Blood withdrawal
blood withdrawal every 2 hours during 24 hours
  • Healthy group
    15 persons with normal renal function
    Intervention: Procedure: Blood withdrawal
  • Renal failure
    15 persons with renal failure (GFR < 60 ml/min)
    Intervention: Procedure: Blood withdrawal
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
April 2013
April 2013   (final data collection date for primary outcome measure)

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)
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01318746
4408
No
University of Erlangen-Nürnberg Medical School
University of Erlangen-Nürnberg Medical School
Biotronik SE & Co. KG
Principal Investigator: Roland E. Schmieder, MD Department of Nephrology and Hypertension, University of Erlangen-Nürnberg Medical School
University of Erlangen-Nürnberg Medical School
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP