NCT05788523

Brief Summary

Dyskalemia, hypo- and hyperkalemia are common in the emergency department and are associated with increased morbidity and mortality. The potential seriousness of dyskalemia results from the potential alteration of intracardiac conduction and the increase in cardiac rhythm disorders, all associated with a lethal risk. Given the aspecific symptoms of dyskalemia and the complex causal links to be acquired, it is difficult to judge the severity of the disorders in front of an initial clinical presentation of a patient in the emergency room, as the patient may present a serious condition during his stay in the emergency room, related to the dyskalemia and not prejudged at first. The ECG is recommended to judge the severity of the disorder, in association with the level of kalemia, but the electrical changes of its pattern in the context of dyskalemia are sometimes so fine that even the eye of the practitioner is not able to detect them. To date and to our knowledge, there is no tool for predicting the risk of RTA or death in dyskalemia. The existing studies on the subject, including ECGs, seek to detect dyskalemia and not its complications, and the proposed tools only take into account the ECG and not the clinical context of the patient.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2023

Shorter than P25 for all trials

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

Study Start

First participant enrolled

January 2, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 15, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 29, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

April 27, 2025

Status Verified

February 1, 2025

Enrollment Period

12 months

First QC Date

March 15, 2023

Last Update Submit

April 25, 2025

Conditions

Keywords

artificial intelligencekalemiadyskalemia

Outcome Measures

Primary Outcomes (1)

  • Number of participants with Cardiac arrest and/or rhythm disorder

    Number of patients with Cardiac arrest and/or rhythm disorder within 48 hours of the ED visit

    within 48 hours

Secondary Outcomes (2)

  • Rate of Mortality

    within 48 hours

  • The type of received treatment for dyskalemia

    within 48 hours

Eligibility Criteria

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

patients consulted in the emergency unit of the participating centre, with quality criteria for the EHCs; this cohort will validate the Artificial Intelligence method developed in partnership with the laboratory

You may qualify if:

  • Major patient consulting in an emergency department participating in the study
  • who received at least a digital ECG AND an ionogram in the emergency department during the study period

You may not qualify if:

  • Patient who has expressed opposition to the reuse of their data for the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHR Metz-Thionville/Hopital de Mercy

Metz, 57085, France

Location

MeSH Terms

Conditions

Emergencies

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Laure ABENSUR VUILLAUME, MD, PhD

    CHR Metz Thionville Hopital de Mercy

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

March 15, 2023

First Posted

March 29, 2023

Study Start

January 2, 2023

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

April 27, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations