Trial document





This trial has been registered retrospectively.
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  DRKS00016411

Trial Description

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Title

Association between potassium levels, variability and supplementation and in-hospital mortality

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Trial Acronym

KaliMo

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Current guidelines do not make a clear statement about how precise potassium target ranges should be set in intensive care patients and from when potassium substitution should take place. Recent studies on patients after myocardial infarction give evidence of reduced mortality in low-normal potassium ranges. In addition, the variability of potassium concentrations in the blood appears to have an influence.
The aim of this retrospective data analysis is to find a potassium range associated with the lowest mortality rate in intensive care patients, as well as to study the influence of variability. Also of interest is the role of potassium substitution and potassium substitution additively to insulin therapy.

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Brief Summary in Scientific Language

Potassium homeostasis is regulated within extracellular concentrations between 3.5 and 5.0 mmol/l. This is of importance for physiologic processes, such as the negative resting membrane potential and consequently neuromuscular and cardiac excitability. Severe hyperkalemia is associated with ventricular arrhythmia, bradycardia and cardiac arrest. Hypo- and hyperkalemia compared to normal rages are associated with an increased complication rate and mortality risk.
In patients with myocardial infarction the American College of Cardiology/American Heart Association (ACC/AHA) Guidelines suggest to elevate potassium levels to 4.0-5.0mmol/l to reduce the risk of ventricular fibrillation. After cardiac and thoracic surgery, guidelines recommend to correct hypokalemia to 4.5-5.5mmol/l to prevent atrial fibrillation, although they emphasize that this suggestion has never been scientifically confirmed. In summary, previous guidelines recommend potassium levels rather in the upper normokalemic range. However, a recent systematic review found evidence that potassium levels above 4.5mmol/l may be adversely associated with survival in patients with myocardial infarction.

Increased mortality has been shown for hyperkalemia in ICU patients. To our knowledge, there is no valid guideline available regarding potassium target ranges and supplementation in ICU patients. The purpose of this retrospective study was to analyze mean potassium levels as well as potassium variability and their association with mortality in a general ICU population. Additionally, we investigated the association of potassium supplementation with mortality.

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Organizational Data

  •   DRKS00016411
  •   2019/01/11
  •   [---]*
  •   yes
  •   Approved
  •   EA2/187/18, Ethik-Kommission der Charité -Universitätsmedizin Berlin-
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Secondary IDs

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Health Condition or Problem studied

  •   E87 -  Other disorders of fluid, electrolyte and acid-base balance
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Interventions/Observational Groups

  •   All intensive care patients in the inclusion interval will be considered.
    All clinical evaluated potassium values ​​of patients during their hospital stay were recorded.
    The hospital routine specifies the frequency and the interval of measurments.
    Performing the analyses, the subdivision is based on potassium mean values ​​and on the standard deviation per patient.
  •   Division in patients of different potassium variability
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Other
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Other
  •   Other
  •   N/A
  •   N/A
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Primary Outcome

in-Hospital mortality dependent on mean potassium levels

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Secondary Outcome

in-Hospital mortality dependent on potassium variability
in-Hospital mortality dependent on potassium substitution

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2018/11/30
  •   50000
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

ICU Patient at Charité University Hospital
from 2006 to 2018

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Exclusion Criteria

less than 2 potassium values during stay

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Addresses

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    • Charité Campus Virchow-Klinikum
    • Augustenburger Platz 1
    • 13353  Berlin
    • Germany
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    • Charité - Universitätsmedizin BerlinKlinik für Anästhesiologie m.S. operative Intensivmedizin
    • Mr.  Dr. med.  Tobias  Wollersheim 
    • Augustenburger Platz 1
    • 13353  Berlin
    • Germany
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    • Charité - Universitätsmedizin BerlinKlinik für Anästhesiologie m.S. operative Intensivmedizin
    • Mr.  Dr. med.  Tobias  Wollersheim 
    • Augustenburger Platz 1
    • 13353  Berlin
    • Germany
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Sources of Monetary or Material Support

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    • Charité - Universitätsmedizin BerlinKlinik für Anästhesiologie m.S. operative Intensivmedizin
    • Mr.  Dr. med.  Tobias  Wollersheim 
    • Augustenburger Platz 1
    • 13353  Berlin
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2018/12/31
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.