NCT06726460 Validation of the Accuracy of a Novel POCT Dry Electrolyte Analysis System in the Acute Care Setting
| NCT ID | NCT06726460 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Zhujiang Hospital |
| Condition | Electrolyte Disorder |
| Study Type | OBSERVATIONAL |
| Enrollment | 200 participants |
| Start Date | 2024-12-17 |
| Primary Completion | 2025-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 200 participants in total. It began in 2024-12-17 with a primary completion date of 2025-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * Patients who are scheduled to undergo electrolyte measuring in the emergency department (ED) or emergency intensive care unit (ICU). Exclusion Criteria: * Patients with a confirmed history of infectious diseases such as hepatitis B, syphilis, HIV/AIDS, etc. * Missing residual sample types (serum or whole blood). * Patients whose residual blood samples are not tested within the specified time frame after collection. * Other patients deemed ineligible by the investigator.
Contact & Investigator
Hua Xie
PRINCIPAL INVESTIGATOR
Zhujiang Hospital, Southern Medical University Organization
Frequently Asked Questions
Who can join the NCT06726460 clinical trial?
This trial is open to participants of all sexes, aged 28 Days or older, studying Electrolyte Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06726460 currently recruiting?
Yes, NCT06726460 is actively recruiting participants. Contact the research team at 52528316@qq.com for enrollment information.
Where is the NCT06726460 trial being conducted?
This trial is being conducted at Guangzhou, China.
Who is sponsoring the NCT06726460 clinical trial?
NCT06726460 is sponsored by Zhujiang Hospital. The principal investigator is Hua Xie at Zhujiang Hospital, Southern Medical University Organization. The trial plans to enroll 200 participants.