Prediction Of Serious Adverse Event in Emergency Department With dysKAlemia, Retrospective Study (PODKA-R)

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.

Study Overview

• Status: Completed
• Conditions: Emergencies

• Study Type: Observational
• Enrollment (Actual): 500

Contacts and Locations

Study Locations

• France
  • Metz, France, 57085
    • CHR Metz-Thionville/Hopital de Mercy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-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

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
The type of received treatment for dyskalemia	The type of treatment received for dyskalemia (IV and what type, orally and what type)	within 48 hours
Rate of Mortality	Rate of Mortality : all causes combined (SAU, hospitalization, SMUR, home)	within 48 hours

Collaborators and Investigators

• Sponsor: Centre Hospitalier Régional Metz-Thionville
• Collaborators: Georgia Institute of Technology
• Investigators: Principal Investigator: Laure ABENSUR VUILLAUME, MD, PhD, CHR Metz Thionville Hopital de Mercy

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2023
• Primary Completion (Actual): December 31, 2023
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: March 15, 2023
• First Submitted That Met QC Criteria: March 15, 2023
• First Posted (Actual): March 29, 2023

Study Record Updates

• Last Update Posted (Actual): April 27, 2025
• Last Update Submitted That Met QC Criteria: April 25, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: artificial intelligence; kalemia; dyskalemia
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Emergencies
• Other Study ID Numbers: 2023-01Obs-CHRMT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No