NCT02020317

Brief Summary

To investigate the impact of reminders for serum potassium monitoring and of hyperkalemia alerts during potassium-increasing drug-drug-interactions.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
3,341

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2014

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

December 12, 2013

Completed
12 days until next milestone

First Posted

Study publicly available on registry

December 24, 2013

Completed
8 days until next milestone

Study Start

First participant enrolled

January 1, 2014

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

June 8, 2015

Status Verified

June 1, 2015

Enrollment Period

1 year

First QC Date

December 12, 2013

Last Update Submit

June 5, 2015

Conditions

Hyperkalemia

Keywords

drug interactionsDrug MonitoringPotassiumHyperkalemia

Outcome Measures

Primary Outcomes (1)

  • 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

    1 year

Secondary Outcomes (6)

  • Frequency of hyperkalemia during potassium-increasing drug-drug-interactions

    1 year

  • Frequency of potassium-increasing drug-drug-interactions ordered in the presence of hyperkalemia

    1 year

  • Frequency of transfers to the ICU during potassium-increasing drug-drug-interactions in function of the serum potassium level

    1 year

  • Frequency of death during potassium-increasing drug-drug-interactions in the presence or absence of hyperkalemia

    1 year

  • Change in frequency distribution of serum potassium monitoring intervals

    1 year

  • +1 more secondary outcomes

Study Arms (2)

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)

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

Interventions

decision support in potassium-inc. drug-drug-interactionsBEHAVIORAL

display of computer-based reminders for serum potassium monitoring and hyperkalemia alerts

computer-based reminders and alerts

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • in-patients treated with concurrent potassium-increasing drugs

You may not qualify if:

  • outpatients; in-patients on wards without computerized physician order entry (i.e. patients treated in the ICU)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Zurich, Center for Clinical Research, Research Center for Medical Informatics

Zurich, Canton of Zurich, 8091, Switzerland

Location

Related Publications (2)

  • 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.

    PMID: 24150532BACKGROUND

  • Eschmann E, Beeler PE, Zund G, Blaser J. Evaluation of alerts for potassium-increasing drug-drug-interactions. Stud Health Technol Inform. 2013;192:1056.

    PMID: 23920830BACKGROUND

MeSH Terms

Conditions

Hyperkalemia

Condition Hierarchy (Ancestors)

Water-Electrolyte ImbalanceMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Juerg Blaser, PhD, Prof

    University Hospital Zurich, Center for Clinical Research, Research Center for Medical Informatics

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 12, 2013

First Posted

December 24, 2013

Study Start

January 1, 2014

Primary Completion

January 1, 2015

Study Completion

January 1, 2015

Last Updated

June 8, 2015

Record last verified: 2015-06

Locations

CH(1)