The Circadian Rhythm of Potassium and Cystatin C (Potassium)

January 11, 2018 updated by: University of Erlangen-Nürnberg Medical School

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Observational

Enrollment (Actual)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Erlangen, Germany, 91054
        • Clinical Research Unit, Department of Nephrology and Hypertension, University of Erlangen-Nürnberg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

healthy persons compared to patients with renal failure

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
twice in 24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
twice in 24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Erlangen-Nürnberg Medical School

Collaborators

Biotronik SE & Co. KG

Investigators

  • Principal Investigator: Roland E. Schmieder, MD, Department of Nephrology and Hypertension, University of Erlangen-Nürnberg Medical School

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2011

Primary Completion (Actual)

April 1, 2013

Study Completion (Actual)

April 1, 2013

Study Registration Dates

First Submitted

March 17, 2011

First Submitted That Met QC Criteria

March 17, 2011

First Posted (Estimate)

March 18, 2011

Study Record Updates

Last Update Posted (Actual)

January 12, 2018

Last Update Submitted That Met QC Criteria

January 11, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4408

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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