HyperkalemiaNCT02020317
Clinical Decision Support System for Quality Assurance in Potassium-Increasing Drug-Drug-Interactions
A study testing decision support in potassium-inc. drug-drug-interactions in people with Hyperkalemia, run by University of Zurich at 1 site in Switzerland.
Trial summary
To investigate the impact of reminders for serum potassium monitoring and of hyperkalemia alerts during potassium-increasing drug-drug-interactions. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hyperkalemia
- What is being tested?
- decision support in potassium-inc. drug-drug-interactions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,341 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jan 2014to Jan 2015
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- in-patients treated with concurrent potassium-increasing drugs
Who cannot join
- outpatients; in-patients on wards without computerized physician order entry (i.e. patients treated in the ICU)
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Zurich, Center for Clinical Research, Research Center for Medical Informatics
Zurich, Canton of Zurich, 8091
About this study
To investigate the impact of reminders for serum potassium monitoring and of hyperkalemia alerts during potassium-increasing drug-drug-interactions.
Read the detailed description
The development of hyperkalemia during potassium-increasing drug-drug-interactions (DDIs) is associated with (i) unknown or elevated serum potassium level at onset of treatment and (ii) insufficient monitoring of serum potassium during therapy. However, potassium-increasing DDIs are frequently started despite an unknown or elevated serum potassium level, and monitoring intervals often exceed 48 hours.
This study investigates the impact of reminders for serum potassium monitoring and hyperkalemia alerts. Both reminders and alerts are displayed in the electronic patient chart of in-patients treated with potassium-increasing DDIs.
- Conditions
- Hyperkalemia
- Being tested
- decision support in potassium-inc. drug-drug-interactions
- Keywords
- drug interactions, Drug Monitoring, Potassium, Hyperkalemia
- Medical subject headings
- Hyperkalemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
decision support in potassium-inc. drug-drug-interactionsBehavioural
display of computer-based reminders for serum potassium monitoring and hyperkalemia alerts
| Study group | Role | What they receive |
|---|---|---|
| computer-based reminders and alerts | Active comparator | Behavioral: display of computer-based reminders for serum potassium monitoring and hyperkalemia alerts (decision support in potassium-inc. drug-drug-interactions) Receives: Behavioral: decision support in potassium-inc. drug-drug-interactions |
| no computer-based reminders or alerts | No intervention | Behavioral: no display of computer-based reminders for serum potassium monitoring and hyperkalemia alerts |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact on serum potassium monitoring during potassium-increasing drug-drug-interactions
Rate of serum potassium monitoring intervals of < = 72 hours during potassium-increasing drug-drug-interactions in proportion to all serum potassium monitoring intervals during potassium-increasing drug-drug-interactions
Measured: 1 year
Secondary outcomes (6)
Frequency of hyperkalemia during potassium-increasing drug-drug-interactions
Measured: 1 year
Frequency of potassium-increasing drug-drug-interactions ordered in the presence of hyperkalemia
Measured: 1 year
Frequency of transfers to the ICU during potassium-increasing drug-drug-interactions in function of the serum potassium level
Measured: 1 year
Frequency of death during potassium-increasing drug-drug-interactions in the presence or absence of hyperkalemia
Measured: 1 year
Change in frequency distribution of serum potassium monitoring intervals
Measured: 1 year
Response of physicians to the computer-based alerts and reminders
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2013 (estimated)
- Study startJan 2014
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HyperkalemiaStudies of the same condition, open and under way.
- More trials run by University of ZurichThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3,341 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Juerg Blaser, PhD, Prof, Principal investigator, University Hospital Zurich, Center for Clinical Research, Research Center for Medical Informatics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02020317
- Sponsor's protocol ID
- FZMI-KEK-ZH-Nr. 2013
- Status last verified
- Jun 2015
- First submitted
- 12 Dec 2013
- Last updated
- 8 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Eschmann E, Beeler PE, Kaplan V, Schneemann M, Zund G, Blaser J. Patient- and physician-related risk factors for hyperkalaemia in potassium-increasing drug-drug interactions. Eur J Clin Pharmacol. 2014 Feb;70(2):215-23. doi: 10.1007/s00228-013-1597-2. Epub 2013 Oct 23.
PubMed 24150532Eschmann E, Beeler PE, Zund G, Blaser J. Evaluation of alerts for potassium-increasing drug-drug-interactions. Stud Health Technol Inform. 2013;192:1056.
PubMed 23920830
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Decision Support System for Quality Assurance in Potassium-Increasing Drug-Drug-Interactions
- ClinicalTrials.gov ID
- NCT02020317
- Acronym / sponsor ID
- FZMI-KEK-ZH-Nr. 2013
- Conditions
- Hyperkalemia
- Keywords
- drug interactions, Drug Monitoring, Potassium, Hyperkalemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,341 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 24 Dec 2013 (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.
To investigate the impact of reminders for serum potassium monitoring and of hyperkalemia alerts during potassium-increasing drug-drug-interactions.
Detailed description
The development of hyperkalemia during potassium-increasing drug-drug-interactions (DDIs) is associated with (i) unknown or elevated serum potassium level at onset of treatment and (ii) insufficient monitoring of serum potassium during therapy. However, potassium-increasing DDIs are frequently started despite an unknown or elevated serum potassium level, and monitoring intervals often exceed 48 hours.
This study investigates the impact of reminders for serum potassium monitoring and hyperkalemia alerts. Both reminders and alerts are displayed in the electronic patient chart of in-patients treated with potassium-increasing DDIs.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| computer-based reminders and alerts | Active comparator | Behavioral: decision support in potassium-inc. drug-drug-interactionsBehavioral: display of computer-based reminders for serum potassium monitoring and hyperkalemia alerts (decision support in potassium-inc. drug-drug-interactions) |
| no computer-based reminders or alerts | No intervention | –Behavioral: no display of computer-based reminders for serum potassium monitoring and hyperkalemia alerts |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- in-patients treated with concurrent potassium-increasing drugs
Key exclusion criteria (1 listed)
- outpatients; in-patients on wards without computerized physician order entry (i.e. patients treated in the ICU)
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 |
|---|---|---|
| decision support in potassium-inc. drug-drug-interactionsdisplay of computer-based reminders for serum potassium monitoring and hyperkalemia alerts | Behavioural | computer-based reminders and alerts |
Primary outcome
Impact on serum potassium monitoring during potassium-increasing drug-drug-interactions
Time frame: 1 year
Rate of serum potassium monitoring intervals of < = 72 hours during potassium-increasing drug-drug-interactions in proportion to all serum potassium monitoring intervals during potassium-increasing drug-drug-interactions
6 secondary outcomes
Frequency of hyperkalemia during potassium-increasing drug-drug-interactions
Time frame: 1 year
Frequency of potassium-increasing drug-drug-interactions ordered in the presence of hyperkalemia
Time frame: 1 year
Frequency of transfers to the ICU during potassium-increasing drug-drug-interactions in function of the serum potassium level
Time frame: 1 year
Frequency of death during potassium-increasing drug-drug-interactions in the presence or absence of hyperkalemia
Time frame: 1 year
Change in frequency distribution of serum potassium monitoring intervals
Time frame: 1 year
Response of physicians to the computer-based alerts and reminders
Time frame: 1 year
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 8 Jun 2015.
- Background: PubMed 24150532Eschmann E, Beeler PE, Kaplan V, Schneemann M, Zund G, Blaser J. Patient- and physician-related risk factors for hyperkalaemia in potassium-increasing drug-drug interactions. Eur J Clin Pharmacol. 2014 Feb;70(2):215-23. doi: 10.1007/s00228-013-1597-2. Epub 2013 Oct 23.
- Background: PubMed 23920830Eschmann E, Beeler PE, Zund G, Blaser J. Evaluation of alerts for potassium-increasing drug-drug-interactions. Stud Health Technol Inform. 2013;192:1056.
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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.
Juerg Blaser, PhD, Prof principal investigator
University Hospital Zurich, Center for Clinical Research, Research Center for Medical Informatics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing decision support in potassium-inc. drug-drug-interactions in people with Hyperkalemia, run by University of Zurich at 1 site in Switzerland.
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 1 inclusion and 1 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 8 Jun 2015. 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 Switzerland. 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?
Impact on serum potassium monitoring during potassium-increasing drug-drug-interactions (time frame: 1 year). 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 NCT02020317, which also lists 2 linked publications.
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 8 Jun 2015.