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NCT01318746 Clinical Trial

The Circadian Rhythm of Potassium and Cystatin C

Sudden Cardiac Death Clinical Trial

— Potassium  

Official title:
The Circadian Rhythm of Potassium and Cystatin c and the Day-to-day Variability

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01318746
Other study ID # 4408
Secondary ID
Status Completed
Phase N/A
First received March 17, 2011
Last updated January 11, 2018
Start date April 2011
Est. completion date April 2013

Study information
Verified date January 2018
Source University of Erlangen-Nürnberg Medical School
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

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

Recruitment information / eligibility
Status Completed
Enrollment 30
Est. completion date April 2013
Est. primary completion date April 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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)

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Blood withdrawal
blood withdrawal every 2 hours during 24 hours

Locations
Country Name City State
Germany Clinical Research Unit, Department of Nephrology and Hypertension, University of Erlangen-Nürnberg Erlangen

Sponsors (2)
Lead Sponsor Collaborator
University of Erlangen-Nürnberg Medical School Biotronik SE & Co. KG

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Schmidt ST, Ditting T, Deutsch B, Schutte R, Friedrich S, Kistner I, Ott C, Raff U, Veelken R, Schmieder RE. Circadian rhythm and day to day variability of serum potassium concentration: a pilot study. J Nephrol. 2015 Apr;28(2):165-72. doi: 10.1007/s40620 — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Potassium rhythm 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.		 twice in 24 hours
Secondary Potassium value in renal failure 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. twice in 24 hours
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