Prediction Of Serious Adverse Event in Emergency Department With dysKAlemia, Retrospective Study

NCT ID: NCT05788523

Last Updated: 2025-04-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-01-02

Study Completion Date

2023-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Emergencies

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

Exclusion Criteria

* Patient who has expressed opposition to the reuse of their data for the study
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Georgia Institute of Technology

OTHER

Sponsor Role collaborator

Centre Hospitalier Régional Metz-Thionville

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Laure ABENSUR VUILLAUME, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

CHR Metz Thionville Hopital de Mercy

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

CHR Metz-Thionville/Hopital de Mercy

Metz, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2023-01Obs-CHRMT

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

The Emergency Call on Drowning
NCT06310486 RECRUITING