Iodine Starch Test Use in Pleuroperitoneal Leak
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNottingham University Hospitals NHS Trust
About this trial
This is an observational study to see how a simple test can be used to check if fluid in the chest cavity contains starch. Some people with kidney failure have dialysis treatment by putting fluid in the tummy cavity, and sometimes the fluid can leak into the chest cavity. Iodine can change the colour of starch based dialysis fluid, so this test could be used to diagnose fluid leaking from the tummy cavity into the chest cavity. The investigators are doing this study to ensure the fluid doesn't change colour for other reasons.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults (aged ≥18 years) attending for diagnostic or therapeutic pleural aspiration.
Able and willing to provide written informed consent for use of a small surplus pleural fluid sample for research purposes.
Sufficient pleural fluid volume (demonstrated on routine pre-procedure thoracic ultrasound scan) available to allow safe collection of at least an additional 10 mL sample without affecting routine clinical testing (clinical samples would require a minimum of 10mLs but common clinical practice is to remove larger volumes in in order to allow symptomatic relief).
Disqualifiers
Under 18 years of age.
Unable to give informed consent (e.g. due to cognitive impairment or lack of capacity).
Trial design
Design model
Single group
Treatments tested in this trial
Iodine tincture
Diagnostic testIodine and potassium iodide 2% (0.1mL)
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: ObservationalOther 1 intervention
Trial outcomes
Primary outcomes
1
False positive results of iodine-starch test (blue-black colour change) when applied to pleural fluid samples from non-dialysis patients on a single sample at baseline
To assess whether the iodine-starch test produces any false positive results when applied to pleural fluid samples from non-dialysis patients on a single sample at baseline.
Time frame
Baseline2
Positive Iodine-starch test (blue black colour change) in the pleural fluid of patients with a pleuroperitoneal leak using Icodextrin, on single baseline pleural fluid sample
To assess whether the iodine-starch test can be used in practice to positively identify icodextrin in the pleural fluid of patients with a pleuroperitoneal leak on a single baseline pleural fluid sample.
Time frame
BaselineLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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