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

Emergencies Clinical Trial

— PODKA-R  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05788523
• Other study ID #: 2023-01Obs-CHRMT
• Status: Recruiting
• Start date: January 2, 2023
• Est. completion date: December 31, 2023

Study information

• Verified date: March 2023
• Source: Centre Hospitalier Régional Metz-Thionville
• Contact: Arpiné EL NAR, PhD
• Phone: 0033387557766
• Email: a.elnar[@]chr-metz-thionville.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Emergencies

Locations

Country	Name	City	State
France	CHR Metz-Thionville/Hopital de Mercy	Metz

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Régional Metz-Thionville	Georgia Institute of Technology

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Rate of Mortality	Rate of Mortality : all causes combined (SAU, hospitalization, SMUR, home)	within 48 hours
Secondary	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