EmergenciesPODKA-RNCT05788523
Prediction Of Serious Adverse Event in Emergency Department With dysKAlemia, Retrospective Study
An observational study of Emergencies, run by Centre Hospitalier Régional Metz-Thionville at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Emergencies
- How many people
- 500 participants
- Where
- 1 siteFrance
- Study dates
- 2 Jan 2023to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- Patient who has expressed opposition to the reuse of their data for the study
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Emergencies
- Keywords
- artificial intelligence, kalemia, dyskalemia
- Medical subject headings
- Emergencies
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: within 48 hours
Secondary outcomes (2)
Rate of Mortality
Rate of Mortality : all causes combined (SAU, hospitalization, SMUR, home)
Measured: within 48 hours
The type of received treatment for dyskalemia
The type of treatment received for dyskalemia (IV and what type, orally and what type)
Measured: within 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2023
- Study start2 Jan 2023
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EmergenciesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Régional Metz-Thionville
- Sponsor type
- University, hospital or other
- Collaborators
- Georgia Institute of Technology
- Responsible party
- Sponsor
- Investigators
- Laure ABENSUR VUILLAUME, MD, PhD, Principal investigator, CHR Metz Thionville Hopital de Mercy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05788523
- Sponsor's protocol ID
- 2023-01Obs-CHRMT
- Acronym
- PODKA-R
- Status last verified
- Feb 2025
- First submitted
- 15 Mar 2023
- Last updated
- 27 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction Of Serious Adverse Event in Emergency Department With dysKAlemia, Retrospective Study
- ClinicalTrials.gov ID
- NCT05788523
- Acronym / sponsor ID
- PODKA-R / 2023-01Obs-CHRMT
- Conditions
- Emergencies
- Keywords
- artificial intelligence, kalemia, dyskalemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Centre Hospitalier Régional Metz-ThionvilleUniversity, hospital or other
- Collaborators
- Georgia Institute of Technology
- Study start
- 2 Jan 2023 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 29 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- Patient who has expressed opposition to the reuse of their data for the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of participants with Cardiac arrest and/or rhythm disorder
Time frame: within 48 hours
Number of patients with Cardiac arrest and/or rhythm disorder within 48 hours of the ED visit
2 secondary outcomes
Rate of Mortality
Time frame: within 48 hours
The type of received treatment for dyskalemia
Time frame: within 48 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laure ABENSUR VUILLAUME, MD, PhD principal investigator
CHR Metz Thionville Hopital de Mercy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Emergencies, run by Centre Hospitalier Régional Metz-Thionville at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with Cardiac arrest and/or rhythm disorder (time frame: within 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2025.