RecruitingACTRN12626000566336

The PLEUral Effusion Rapid Analysis using DIPsticks (PLEURADIP) Study: Evaluation of Automatic Urine Dipstick Analysis as a Point of Care Test

The PLEUral Effusion Rapid Analysis using DIPsticks (PLEURADIP) Study: Evaluation of Automatic Urine Dipstick Analysis as a Point of Care Test in patients with pleural effusions

Sponsor

Western Sydney Local Health District

Enrollment

200 participants

Start Date

Sep 30, 2025

Study Type

Interventional

Conditions

Pleural Effusion

Summary

Pleural effusion is the abnormal accumulation of fluid in the space within the chest wall but outside the lung. In Australia, approximately 60,000 patients are found to have pleural effusions each year, of which there are multiple aetiologies. Pleural fluid biochemical and cellular analysis remains the gold standard for diagnosis, including the classification into transudative and exudative effusions using Light’s Criteria, which compares serum to pleural fluid protein and LDH levels. However, pleural fluid laboratory testing can take several hours to return and results cannot therefore be determined during the same procedure. Commerical urine reagent strips are cheap, readily available in the hospital setting and can provide rapid results within 1-2 minutes. The purspose of this study is to test the utility of urine reagent strips as a point of care test for pleural effusions to differentiate between different pleural effusion types.

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Inclusion Criteria7

Pleural dipstick analysis
Patient > 18 years.
Informed consent for pleural procedure
Pleural effusion confirmed radiologically (either diagnostic ultrasound or on chest imaging) deemed safe for interventional pleural procedure and planned for pleural procedure.
Pleural procedure being performed.
Pleural dipstick questionnaire
Clinical staff with experience in urine dipstick analysis and pleural effusion management

Exclusion Criteria4

Pleural effusion too small for safe pleural procedure (up to the discretion of the proceduralist as per usual clinical management protocols).
Contraindications to pleural procedure (e.g. uncorrected coagulopathies).
Inability to provide informed consent for the pleural procedure.
Insufficient pleural fluid for dipstick analysis (<30ml).

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Interventions

Hospitalised patients undergoing plueral procedures will be included in the study. Pleural fluid will be collected in a sterile specimen jar as per standard clinical practure during the pleural procedure. For patients enrolled in the study, an additional 30mls of pleural fluid will be collected in a sterile specimen jar. If there is an insufficient amount of pleural fluid available for analysis of routine pleural fluid tests, a sample for urine dipstick analysis will not be collected and the patient will not be included in the study. After the pleural procedure has been completed, the pleural fluid study sample will be dipped by a staff member with experience using urine dipsticks, with a Multistix® 10 SG Reagent Strip (Siemens) and the visual results recorded against the standardised interpretation chart as per the manufacturers instructions. A second urine dipstick will be analysed using a urine dipstick auto analyser (CLINITEK Status®+ Analyzer Siemens). Both dipsticks will be systematically analysed within 2 minutes of pleural fluid collection and results documented. Treating teams will not be informed of the dipstick results. The patients will be managed by their treating team as usual pre and post procedure, and there will be no direct impact upon patient’s care that deviates from usual standard of care practices for pleural effusion management. A review of the electronic medical record will be performed to collect formal pleural fluid laboratory results and final pleural effusion diagnosis as determined by the treating clinicians.