The Circadian Rhythm of Potassium and Cystatin C

NCT ID: NCT01318746

Last Updated: 2018-01-12

Study Results

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-04-30

Study Completion Date

2013-04-30

Brief Summary

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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.

Detailed Description

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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

Conditions

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Cardiac Arrhythmias Sudden Cardiac Death

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Healthy group

15 persons with normal renal function

Blood withdrawal

Intervention Type PROCEDURE

blood withdrawal every 2 hours during 24 hours

Renal failure

15 persons with renal failure (GFR \< 60 ml/min)

Blood withdrawal

Intervention Type PROCEDURE

blood withdrawal every 2 hours during 24 hours

Interventions

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Blood withdrawal

blood withdrawal every 2 hours during 24 hours

Intervention Type PROCEDURE

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Biotronik SE & Co. KG

INDUSTRY

Sponsor Role collaborator

University of Erlangen-Nürnberg Medical School

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Roland E. Schmieder, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Nephrology and Hypertension, University of Erlangen-Nürnberg Medical School

Locations

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Clinical Research Unit, Department of Nephrology and Hypertension, University of Erlangen-Nürnberg

Erlangen, , Germany

Site Status

Countries

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Germany

References

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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/s40620-014-0115-7. Epub 2014 Jul 3.

Reference Type RESULT
PMID: 24990164 (View on PubMed)

Other Identifiers

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4408

Identifier Type: -

Identifier Source: org_study_id

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