NCT06726460Recruiting
Validation of the Accuracy of a Novel POCT Dry Electrolyte Analysis System in the Acute Care Setting
Validation of the Accuracy of a Novel POCT Dry Electrolyte Analysis System in the Acute Care Setting: A Cross-Sectional Study
Source: ClinicalTrials.gov · Last updated 18 Jul 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The goal of this study is to compare the performance of a novel Point-of-Care Testing (POCT) dry electrolyte analyzer (P1) with the Nova Stat Profile pHOx Ultra Analyzer System (Nova) in an acute care setting. The main questions it aims to answer are: 1. How consistent are the results between P1 and Nova in the emergency setting, including outliers, correlation, linearity, and bias? 2. Whether P1 can serve as a suitable alternative to Nova in the acute care setting for electrolyte measurement in the emergency environment. Participants will be patients in the emergency department who will undergo simultaneous measurement with P1 and Nova during their emergency care to assess the performance of both devices. Additionally, the study will investigate electrolyte levels in emergency patients, focusing on the prevalence of abnormal ionized magnesium (iMg2+) levels, the correlation between iMg2+ and total magnesium (tMg), and the clinical significance of iMg2+ measurement.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 200 (estimated)
- First submitted
- 4 Dec 2024
- Start date
- 17 Dec 2024
- Primary completion date
- 31 Aug 2025
- Lead sponsor
- Zhujiang Hospital
- Diseases
- Stroke
- NCT number
- NCT06726460
What you commit to
- Study type: Observational
- Planned participants: 200
- From 17 Dec 2024 to the primary completion date, 31 Aug 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Patients with a confirmed history of infectious diseases such as hepatitis B, syphilis, HIV/AIDS, etc.
Lab values
- Missing residual sample types (serum or whole blood).
Other
- Patients whose residual blood samples are not tested within the specified time frame after collection.
- Other patients deemed ineligible by the investigator.
Who the study is looking for
- Patients who are scheduled to undergo electrolyte measuring in the emergency department (ED) or emergency intensive care unit (ICU).
Age in the registry: 28 days to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Zhujiang Hospital, Southern Medical University Organization Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.