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

Sponsor
Centre Hospitalier Régional Metz-Thionville (Other)
Overall Status
Recruiting
CT.gov ID
NCT05788523
Collaborator
Georgia Institute of Technology (Other)
500
1
11.9
41.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    500 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Prediction Of Serious Adverse Event in Emergency Department With dysKAlemia, Retrospective Study
    Actual Study Start Date :
    Jan 2, 2023
    Anticipated Primary Completion Date :
    Dec 31, 2023
    Anticipated Study Completion Date :
    Dec 31, 2023

    Outcome Measures

    Primary Outcome Measures

    1. Number of participants with Cardiac arrest and/or rhythm disorder [within 48 hours]

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

    Secondary Outcome Measures

    1. Rate of Mortality [within 48 hours]

      Rate of Mortality : all causes combined (SAU, hospitalization, SMUR, home)

    2. The type of received treatment for dyskalemia [within 48 hours]

      The type of treatment received for dyskalemia (IV and what type, orally and what type)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 CHR Metz-Thionville/Hopital de Mercy Metz France 57085

    Sponsors and Collaborators

    • Centre Hospitalier Régional Metz-Thionville
    • Georgia Institute of Technology

    Investigators

    • Principal Investigator: Laure ABENSUR VUILLAUME, MD, PhD, CHR Metz Thionville Hopital de Mercy

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Centre Hospitalier Régional Metz-Thionville
    ClinicalTrials.gov Identifier:
    NCT05788523
    Other Study ID Numbers:
    • 2023-01Obs-CHRMT
    First Posted:
    Mar 29, 2023
    Last Update Posted:
    Mar 30, 2023
    Last Verified:
    Mar 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Centre Hospitalier Régional Metz-Thionville
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 30, 2023