Cardiac ArrhythmiasPotassiumNCT01318746
The Circadian Rhythm of Potassium and Cystatin C
An observational study of Cardiac Arrhythmias and Sudden Cardiac Death, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiac Arrhythmias, Sudden Cardiac Death
- What is being tested?
- Blood withdrawal
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2011to Apr 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: healthy persons compared to patients with renal failure
Who may be able to join
- at least 18 years old
- normal renal function and impaired renal function (GFR < 60 ml/min) respectively
Who cannot join
- pregnancy
- anaemia (Hb<10 mg/dl)
Trial locations and contacts
1 site in 1 country.
Germany1 site
Clinical Research Unit, Department of Nephrology and Hypertension, University of Erlangen-Nürnberg
Erlangen, 91054
About this study
Official title: 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.
Read the 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
- Conditions
- Cardiac Arrhythmias, Sudden Cardiac Death
- Being tested
- Blood withdrawal
- Keywords
- change of potassium amount, circadian and day-to-day variability
- Medical subject headings
- Arrhythmias, Cardiac, Death, Sudden, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood withdrawalProcedure or surgery
blood withdrawal every 2 hours during 24 hours
| Study group | Role | What they receive |
|---|---|---|
| Healthy group | 15 persons with normal renal function Receives: Procedure: Blood withdrawal | |
| Renal failure | 15 persons with renal failure (GFR < 60 ml/min) Receives: Procedure: Blood withdrawal |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: twice in 24 hours
Secondary outcomes (1)
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.
Measured: twice in 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2011 (estimated)
- Study startApr 2011
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiac ArrhythmiasStudies of the same condition, open and under way.
- More trials run by University of Erlangen-Nürnberg Medical SchoolThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Erlangen-Nürnberg Medical School
- Sponsor type
- University, hospital or other
- Collaborators
- Biotronik SE & Co. KG
- Responsible party
- Sponsor
- Investigators
- Roland E. Schmieder, MD, Principal investigator, Department of Nephrology and Hypertension, University of Erlangen-Nürnberg Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01318746
- Sponsor's protocol ID
- 4408
- Acronym
- Potassium
- Status last verified
- Jan 2018
- First submitted
- 17 Mar 2011
- Last updated
- 12 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 24990164
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Circadian Rhythm of Potassium and Cystatin c and the Day-to-day Variability
- ClinicalTrials.gov ID
- NCT01318746
- Acronym / sponsor ID
- Potassium / 4408
- Conditions
- Cardiac Arrhythmias, Sudden Cardiac Death
- Keywords
- change of potassium amount, circadian and day-to-day variability
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of Erlangen-Nürnberg Medical SchoolUniversity, hospital or other
- Collaborators
- Biotronik SE & Co. KG
- Study start
- Apr 2011
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 18 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy group | – | Procedure: Blood withdrawal15 persons with normal renal function |
| Renal failure | – | Procedure: Blood withdrawal15 persons with renal failure (GFR < 60 ml/min) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- healthy persons compared to patients with renal failure
Key inclusion criteria (2 listed)
- at least 18 years old
- normal renal function and impaired renal function (GFR < 60 ml/min) respectively
Key exclusion criteria (2 listed)
- pregnancy
- anaemia (Hb<10 mg/dl)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood withdrawalblood withdrawal every 2 hours during 24 hours | Procedure or surgery | Healthy group, Renal failure |
Primary outcome
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.
1 secondary outcome
Potassium value in renal failure
Time frame: twice in 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2018.
- Results publication: PubMed 24990164Schmidt 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roland E. Schmieder, MD principal investigator
Department of Nephrology and Hypertension, University of Erlangen-Nürnberg Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Arrhythmias and Sudden Cardiac Death, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Potassium rhythm (time frame: twice in 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01318746, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2018.