NCT01318746

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 17, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 18, 2011

Completed
14 days until next milestone

Study Start

First participant enrolled

April 1, 2011

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
Last Updated

January 12, 2018

Status Verified

January 1, 2018

Enrollment Period

2 years

First QC Date

March 17, 2011

Last Update Submit

January 11, 2018

Conditions

Cardiac ArrhythmiasSudden Cardiac Death

Keywords

change of potassium amount, circadian and day-to-day variability

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Potassium value in renal failure

    twice in 24 hours

Study Arms (2)

Healthy group

15 persons with normal renal function

Procedure: Blood withdrawal

Renal failure

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

Procedure: Blood withdrawal

Interventions

Blood withdrawalPROCEDURE

blood withdrawal every 2 hours during 24 hours

Healthy groupRenal failure

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

healthy persons compared to patients with renal failure

You may qualify if:

  • at least 18 years old
  • normal renal function and impaired renal function (GFR \< 60 ml/min) respectively

You may not qualify if:

  • pregnancy
  • anaemia (Hb\<10 mg/dl)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Erlangen, 91054, Germany

Location

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

    PMID: 24990164RESULT

MeSH Terms

Conditions

Arrhythmias, CardiacDeath, Sudden, Cardiac

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsHeart ArrestDeath, SuddenDeath

Study Officials

  • Roland E. Schmieder, MD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 17, 2011

First Posted

March 18, 2011

Study Start

April 1, 2011

Primary Completion

April 1, 2013

Study Completion

April 1, 2013

Last Updated

January 12, 2018

Record last verified: 2018-01

Locations

DE(1)