Association between potassium levels, variability and supplementation and in-hospital mortality
Organizational Data
- DRKS-ID:
- DRKS00016411
- Recruitment Status:
- Recruiting complete, study complete
- Date of registration in DRKS:
- 2019-01-11
- Last update in DRKS:
- 2019-01-11
- Registration type:
- Retrospective
Acronym/abbreviation of the study
KaliMo
URL of the study
No Entry
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.
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.
Health condition or problem studied
- ICD10:
- E87 - Other disorders of fluid, electrolyte and acid-base balance
- Healthy volunteers:
- No Entry
Interventions, Observational Groups
- Arm 1:
- 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.
- Arm 2:
- Division in patients of different potassium variability
Endpoints
- Primary outcome:
- in-Hospital mortality dependent on mean potassium levels
- Secondary outcome:
- in-Hospital mortality dependent on potassium variability in-Hospital mortality dependent on potassium substitution
Study Design
- Purpose:
- Other
- Retrospective/prospective:
- No Entry
- Study type:
- Non-interventional
- Longitudinal/cross-sectional:
- No Entry
- Study type non-interventional:
- No Entry
Recruitment
- Recruitment Status:
- Recruiting complete, study complete
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Germany
- Number of study centers:
- Monocenter study
- Recruitment location(s):
-
- University medical center Charité Universitätsmedizin Berlin Berlin
Recruitment period and number of participants
- Planned study start date:
- No Entry
- Actual study start date:
- 2018-11-30
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- 2018-12-31
- Target Sample Size:
- 50000
- Final Sample Size:
- 53248
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 18 Years
- Maximum Age:
- no maximum age
- Additional Inclusion Criteria:
- ICU Patient at Charité University Hospital from 2006 to 2018
Exclusion Criteria
less than 2 potassium values during stay
Addresses
Primary Sponsor
- Address:
- Charité Campus Virchow-KlinikumAugustenburger Platz 113353 BerlinGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.charite.de
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- Charité - Universitätsmedizin BerlinKlinik für Anästhesiologie m.S. operative IntensivmedizinDr. med. Tobias WollersheimAugustenburger Platz 113353 BerlinGermany
- Telephone:
- 030450651808
- Fax:
- 030450551909
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.charite.de
Contact for Public Queries
- Address:
- Charité - Universitätsmedizin BerlinKlinik für Anästhesiologie m.S. operative IntensivmedizinDr. med. Tobias WollersheimAugustenburger Platz 113353 BerlinGermany
- Telephone:
- 030450651808
- Fax:
- 030450551909
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.charite.de
Principal Investigator
- Address:
- Charité - Universitätsmedizin BerlinKlinik für Anästhesiologie m.S. operative IntensivmedizinDr. med. Tobias WollersheimAugustenburger Platz 113353 BerlinGermany
- Telephone:
- 030450651808
- Fax:
- 030450551909
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.charite.de
Sources of Monetary or Material Support
Institutional budget, no external funding (budget of sponsor/PI)
- Address:
- Charité - Universitätsmedizin BerlinKlinik für Anästhesiologie m.S. operative IntensivmedizinAugustenburger Platz 113353 BerlinGermany
- Telephone:
- 030450651808
- Fax:
- 030450551909
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.charite.de
Ethics Committee
Address Ethics Committee
- Address:
- Ethikkommission der Charité – Universitätsmedizin BerlinCharitéplatz 110117 BerlinGermany
- Telephone:
- (+49)30-450517222
- Fax:
- (+49)30-450517952
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2018-09-03
- Ethics committee number:
- EA2/187/18
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2018-11-30
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- No Entry
- IPD Sharing Plan:
- No Entry
Study protocol and other study documents
- Study protocols:
- No Entry
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- No Entry
- Publikationen/Studienergebnisse:
- No Entry
- Date of first publication of study results:
- No Entry
- DRKS entry published for the first time with results:
- No Entry
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry