Peritoneal DialysisPIT-PLPDNCT07857564
Iodine Starch Test Use in Pleuroperitoneal Leak
A study testing Iodine tincture in people with Peritoneal Dialysis and Peritoneal Dialysis (PD), run by Nottingham University Hospitals NHS Trust.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peritoneal Dialysis, Peritoneal Dialysis (PD), Pleural Cavity Effusion
- What is being tested?
- Iodine tincture
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2026to 1 Dec 2027
- Phase
- Interventional
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- Under 18 years of age.
- Unable to give informed consent (e.g. due to cognitive impairment or lack of capacity).
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Practical Use of the Iodine Starch Test to Aid Diagnosis of Pleuroperitoneal Leak in Patients on Peritoneal Dialysis Using Icodextrin
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.
Read the detailed description
This is an observational study involving adult patients who are already undergoing a pleural fluid drainage procedure as part of their routine clinical care. The study is based on the results of a laboratory proof of principle experiment which the investigators performed in the NUH BioResource and Research \& Innovation Laboratory in November 2025, using non-clinical samples of standard peritoneal dialysis fluid to determine how much and what type of iodine is able to differentiate icodextrin from glucose or amino acid based peritoneal dialysis fluids. This has allowed the investigators to determine a clinical test in order to undertake an observational study of both non-dialysis patients who present to the pleural clinic (controls) and patients on peritoneal dialysis presenting with effusions to the renal unit, to ensure the iodine starch can be used in practice and that the test does not produce false positive results in patients with pleural effusions of other causes. The investigators will perform an observational control study in order to ensure that false positive results do not occur in pleural effusions of other causes. The investigators will consent 15 patients undergoing diagnostic or therapeutic pleural aspiration in the NUH pleural clinic. The sample size is an estimate based on the typical incidence of different pleural fluid types obtained in the NUH pleural clinic, and is expected to be sufficient to ensure we obtain samples of transudative, exudative and blood-stained effusion samples. The investigators will concurrently perform an observational study of patients on peritoneal dialysis who undergo diagnostic pleural aspiration (usually to investigate a possible pleuroperitoneal leak). The investigators will recruit five patients on peritoneal dialysis who present with pleural effusion to the Renal Home Therapies Unit. Up to five patients on peritoneal dialysis will also be recruited from two other UK centres. Potential participants will be identified by their usual clinical team when they attend the pleural clinic or renal service for a planned diagnostic or therapeutic pleural aspiration. Participants will consent for the investigators to collect 20mL of pleural fluid that is surplus to that required for clinical purposes. This will not require any changes to practice as it is standard clinical practice to remove larger volumes of fluid to relieve patients symptoms, and discard the waste fluid. The investigators add the pre-determined volume of Iodine and potassium iodide 2% (0.1mL) to 10mL of pleural fluid. The investigators will photograph the samples in the BioResource and Research \& Innovation Laboratory using a standard iPhone camera on an NUH provided work iPhone, and then discard the samples. The remaining 10mL will be frozen at -80oCin the BioResource and Research \& Innovation Laboratory to allow comparison of samples taken at different times, and reproducibility verification or collaborative validation with the other two renal units in the UK. Frozen samples will be kept for 2 years.
Following consent patients will be allocated a study number and pseudonomysed for completion of CRF. The investigators will collect demographic data (age, sex) and relevant past medical history (chronic kidney disease, chronic obstructive pulmonary disease, diabetes, heart failure, ischaemic heart disease, hypertension)from each recruit, results of biochemical tests conducted in NUH laboratories as part of their standard care, and diagnostic information.
Based on the outcome of the clinical study and the background laboratory studies the investigators will be able to validate recommendations about the volume and type of iodine needed to identify the presence of icodextrin in a pleural aspiration sample, which were demonstrated in the laboratory experiment.
- Being tested
- Iodine tincture
- Keywords
- Peritoneal dialysis, Icodextrin, Pleuroperitoneal leak, Pleural effusion, Hydrothorax
- Medical subject headings
- Pleural Effusion, Hydrothorax
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iodine tinctureDiagnostic test
Iodine and potassium iodide 2% (0.1mL)
| Study group | Role | What they receive |
|---|---|---|
| Observational | Other | Observation Receives: Diagnostic Test: Iodine tincture |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2026
- Study start1 Dec 2026 (estimated)
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peritoneal DialysisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nottingham University Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07857564
- Sponsor's protocol ID
- 26RE001
- Acronym
- PIT-PLPD
- Status last verified
- Sep 2026
- First submitted
- 22 Sep 2026
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Observational study only