AzTrials
AzTrials

Electrolyte DisorderNCT06726460

Validation of the Accuracy of a Novel POCT Dry Electrolyte Analysis System in the Acute Care Setting

An observational study of Electrolyte Disorder and Arrhythmia, run by Zhujiang Hospital at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 28 days and older
Conditions the study is for
Electrolyte Disorder, Arrhythmia, Stroke
What is being tested?
Nova Stat Profile pHOx Ultra Analyzer System(Nova) and Novel POCT dry electrolyte analysis system(P1)
How many people
200 participants
Where
1 siteChina
Study dates
17 Dec 2024to 31 Oct 2025
Phase
Observational
Are there results?
Not yet: the study is under way

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 28 days and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: The study population consists of patients presenting to the emergency department (ED) or admitted to the emergency intensive care unit (ICU) who are scheduled to undergo electrolyte measuring.

Who may be able to join

  • Patients who are scheduled to undergo electrolyte measuring in the emergency department (ED) or emergency intensive care unit (ICU).

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Hua Xie contact

+86 19802050526

52528316@qq.com

China1 site, 1 recruiting

  • Zhujiang Hospital, Southern Medical University Organization

    Guangzhou, Guangdong, 510000

    Hua Xie, +86 19802050526, 52528316@qq.com

    Recruiting

Other trials in China

About this study

Official title: Validation of the Accuracy of a Novel POCT Dry Electrolyte Analysis System in the Acute Care Setting: A Cross-Sectional Study

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.
Read more

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.

Read the detailed description

This observational study aims to compare the performance of two electrolyte analysis systems, the electrolyte analyzer P1 and the Nova Stat Profile pHOx Ultra Analyzer System, in an emergency department (ED) or emergency intensive care unit (ICU) setting. The study will evaluate the consistency, correlation, and bias between the two electrolyte analysis systems. The study design is observational, with no intervention or treatment assigned to the participants. The comparison will be made using residual blood samples collected as part of routine care, following standard clinical procedures.

Being tested
Nova Stat Profile pHOx Ultra Analyzer System(Nova), Novel POCT dry electrolyte analysis system(P1)
Keywords
Electrolyte Analyzer, Accuracy, P1, Eaglenos
Medical subject headings
Arrhythmias, Cardiac, Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Nova Stat Profile pHOx Ultra Analyzer System(Nova)Diagnostic test

    This group involves the use of Nova for measuring serum and whole blood samples. The results from Nova will be compared with those obtained from P1.

  • Novel POCT dry electrolyte analysis system(P1)Diagnostic test

    This group involves the use of P1 for measuring serum and whole blood samples. The results from P1 will be compared with those obtained from Nova.

Study groups in NCT06726460
Study groupRoleWhat they receive
Group 1: Nova GroupThis group involves the use of the Nova Stat Profile pHOx Ultra Analyzer System for measuring serum and whole blood samples. The results obtained from Nova will be compared with those obtained from P1.
Receives: Diagnostic Test: Nova Stat Profile pHOx Ultra Analyzer System(Nova)
Group 1: P1 GroupThis group involves the use of the novel POCT dry electrolyte analysis system P1 for measuring serum and whole blood samples. The results obtained from P1 will be compared with those obtained from Nova.
Receives: Diagnostic Test: Novel POCT dry electrolyte analysis system(P1)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Consistency between P1 and Nova system for electrolyte parameters.

    This outcome measure is to evaluate the consistency between the novel POCT dry electrolyte analysis system (P1) and the Nova Stat Profile pHOx Ultra Analyzer System (Nova). Consistency will be assessed by comparing the results of electrolyte parameters (e.g., Sodium (Na+), Potassium (K+), Chloride (Cl-), Ionized calcium (iCa2+), Ionized magnesium (iMg2+)) and will be evaluated using Bland-Altman analysis.

    Measured: Within 30 minutes of serum sample collection and within 1 minute of whole blood sample collection

  2. Correlation between P1 and Nova for electrolyte parameters.

    This outcome measures the correlation between P1 and Nova for electrolyte parameters (e.g., Na+, K+, Cl-, iCa2+, iMg2+). The correlation will be quantified using Pearson's correlation coefficient

    Measured: Within 30 minutes of serum sample collection and within 1 minute of whole blood sample collection

  3. Bias at clinical decision levels between P1 and Nova.

    This outcome measure is to evaluate the bias at clinical decision levels between P1 and Nova. Bias will be assessed by calculating the difference in the results of key electrolyte parameters (e.g., Na+, K+, Cl-, iCa2+, iMg2+) between the two analysis system at clinically relevant thresholds. These thresholds will be based on established clinical decision points where treatment decisions are made.

    Measured: Within 30 minutes of serum sample collection and within 1 minute of whole blood sample collection

  4. Outlier Detection in electrolyte Parameters

    This outcome measure aims to identify and evaluate outliers in the electrolyte parameters measured by P1 and Nova. Outliers will be detected using statistical methods such as the Grubbs test or the Interquartile Range (IQR) method. The impact of these outliers on the consistency and accuracy of the measurements will also be assessed.

    Measured: Within 30 minutes of serum sample collection and within 1 minute of whole blood sample collection

Secondary outcomes (2)

  1. Prevalence of abnormal iMg2+ (ionized magnesium) levels in emergency patients.

    This outcome will assess the prevalence of abnormal ionized magnesium (iMg2+) levels in patients admitted to the emergency department or emergency ICU.

    Measured: Within 30 minutes of serum sample collection and within 1 minute of whole blood sample collection

  2. Correlation between iMg2+ (ionized magnesium) and tMg (total magnesium) levels.

    This outcome will evaluate the correlation between ionized magnesium (iMg2+) levels and total magnesium (tMg) levels, with tMg levels obtained from central laboratory test results, in emergency patients.

    Measured: Within 30 minutes of serum sample collection

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Dec 2024
  2. Study start17 Dec 2024
  3. Primary completion31 Aug 2025 (estimated)
  4. Study completion31 Oct 2025 (estimated)

Resources

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
Other
Time perspective
Cross-sectional
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06726460
Sponsor's protocol ID
2024-KY-405-01
Status last verified
Jun 2025
First submitted
4 Dec 2024
Last updated
18 Jul 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: All collected IPD

Publications

  • Khan AI, Pratumvinit B, Jacobs E, Kost GJ, Kary H, Balla J, Shaw J, Milevoj Kopcinovic L, Vaubourdolle M, Oliver P, Jarvis PRE, Pamidi P, Erasmus RT, O'Kelly R, Musaad S, Sandberg S. Point-of-care testing performed by healthcare professionals outside the hospital setting: consensus based recommendations from the IFCC Committee on Point-of-Care Testing (IFCC C-POCT). Clin Chem Lab Med. 2023 Jun 2;61(9):1572-1579. doi: 10.1515/cclm-2023-0502. Print 2023 Aug 28.

    PubMed 37267483

  • Shi Q, Ba G, Li K, Mao Z. Is it practical to incorporate point-of-care testing into clinical prediction models for emergency? Intern Emerg Med. 2023 Oct;18(7):2155-2156. doi: 10.1007/s11739-023-03333-5. Epub 2023 Jun 6. No abstract available.

    PubMed 37278909

  • Johansson M, Whiss PA. Weak relationship between ionized and total magnesium in serum of patients requiring magnesium status. Biol Trace Elem Res. 2007 Jan;115(1):13-21. doi: 10.1385/BTER:115:1:13.

    PubMed 17406070

  • Escuela MP, Guerra M, Anon JM, Martinez-Vizcaino V, Zapatero MD, Garcia-Jalon A, Celaya S. Total and ionized serum magnesium in critically ill patients. Intensive Care Med. 2005 Jan;31(1):151-6. doi: 10.1007/s00134-004-2508-x. Epub 2004 Dec 17.

    PubMed 15605229

  • Oost LJ, van der Heijden AAWA, Vermeulen EA, Bos C, Elders PJM, Slieker RC, Kurstjens S, van Berkel M, Hoenderop JGJ, Tack CJ, Beulens JWJ, de Baaij JHF. Serum Magnesium Is Inversely Associated With Heart Failure, Atrial Fibrillation, and Microvascular Complications in Type 2 Diabetes. Diabetes Care. 2021 Aug;44(8):1757-1765. doi: 10.2337/dc21-0236. Epub 2021 Jun 18.

    PubMed 34385344

  • Rios FJ, Zou ZG, Harvey AP, Harvey KY, Nosalski R, Anyfanti P, Camargo LL, Lacchini S, Ryazanov AG, Ryazanova L, McGrath S, Guzik TJ, Goodyear CS, Montezano AC, Touyz RM. Chanzyme TRPM7 protects against cardiovascular inflammation and fibrosis. Cardiovasc Res. 2020 Mar 1;116(3):721-735. doi: 10.1093/cvr/cvz164.

    PubMed 31250885

  • Yogi A, Callera GE, Antunes TT, Tostes RC, Touyz RM. Transient receptor potential melastatin 7 (TRPM7) cation channels, magnesium and the vascular system in hypertension. Circ J. 2011;75(2):237-45. doi: 10.1253/circj.cj-10-1021. Epub 2010 Dec 7.

    PubMed 21150127

  • de Baaij JH, Hoenderop JG, Bindels RJ. Magnesium in man: implications for health and disease. Physiol Rev. 2015 Jan;95(1):1-46. doi: 10.1152/physrev.00012.2014.

    PubMed 25540137

  • Ye L, Zhang C, Duan Q, Shao Y, Zhou J. Association of Magnesium Depletion Score With Cardiovascular Disease and Its Association With Longitudinal Mortality in Patients With Cardiovascular Disease. J Am Heart Assoc. 2023 Sep 19;12(18):e030077. doi: 10.1161/JAHA.123.030077. Epub 2023 Sep 8.

    PubMed 37681518

  • Glasdam SM, Glasdam S, Peters GH. The Importance of Magnesium in the Human Body: A Systematic Literature Review. Adv Clin Chem. 2016;73:169-93. doi: 10.1016/bs.acc.2015.10.002. Epub 2016 Jan 13.

    PubMed 26975973

  • Olsson K, Ohlin B, Melander O. Epidemiology and characteristics of hyponatremia in the emergency department. Eur J Intern Med. 2013 Mar;24(2):110-6. doi: 10.1016/j.ejim.2012.10.014. Epub 2012 Nov 22.

    PubMed 23176963

  • Abensur Vuillaume L, Ferreira JP, Asseray N, Trombert-Paviot B, Montassier E, Legrand M, Girerd N, Boivin JM, Chouihed T, Rossignol P. Hypokalemia is frequent and has prognostic implications in stable patients attending the emergency department. PLoS One. 2020 Aug 4;15(8):e0236934. doi: 10.1371/journal.pone.0236934. eCollection 2020.

    PubMed 32750075

  • Ookuma T, Miyasho K, Kashitani N, Beika N, Ishibashi N, Yamashita T, Ujike Y. The clinical relevance of plasma potassium abnormalities on admission in trauma patients: a retrospective observational study. J Intensive Care. 2015 Aug 13;3(1):37. doi: 10.1186/s40560-015-0103-6. eCollection 2015.

    PubMed 26269745

  • Fleet JL, Shariff SZ, Gandhi S, Weir MA, Jain AK, Garg AX. Validity of the International Classification of Diseases 10th revision code for hyperkalaemia in elderly patients at presentation to an emergency department and at hospital admission. BMJ Open. 2012 Dec 28;2(6):e002011. doi: 10.1136/bmjopen-2012-002011. Print 2012.

    PubMed 23274674

  • Muschart X, Boulouffe C, Jamart J, Nougon G, Gerard V, de Canniere L, Vanpee D. A determination of the current causes of hyperkalaemia and whether they have changed over the past 25 years. Acta Clin Belg. 2014 Aug;69(4):280-4. doi: 10.1179/0001551214Z.00000000077. Epub 2014 Jun 18.

    PubMed 24942977

Questions about this trial

What is this clinical trial studying?

An observational study of Electrolyte Disorder and Arrhythmia, run by Zhujiang Hospital at 1 site in China.

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 1 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 18 Jul 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 China. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Hua Xie (+86 19802050526, 52528316@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Consistency between P1 and Nova system for electrolyte parameters. (time frame: Within 30 minutes of serum sample collection and within 1 minute of whole blood sample collection). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06726460, which also lists 15 linked publications.

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 18 Jul 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in