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 a 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
- 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 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 a 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 a 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 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 a 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 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
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Observational study only
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Practical Use of the Iodine Starch Test to Aid Diagnosis of Pleuroperitoneal Leak in Patients on Peritoneal Dialysis Using Icodextrin
- ClinicalTrials.gov ID
- NCT07857564
- Acronym / sponsor ID
- PIT-PLPD / 26RE001
- Keywords
- Peritoneal dialysis, Icodextrin, Pleuroperitoneal leak, Pleural effusion, Hydrothorax
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Nottingham University Hospitals NHS TrustUniversity, hospital or other
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 5 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a 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.
Detailed description
This is a 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 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 a 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 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational | Other | Diagnostic Test: Iodine tinctureObservation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (2 listed)
- Under 18 years of age.
- Unable to give informed consent (e.g. due to cognitive impairment or lack of capacity).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Iodine tinctureIodine and potassium iodide 2% (0.1mL) | Diagnostic test | Observational |
Primary outcome
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
Time frame: 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.
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
Time frame: Baseline
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Individual participant dataSharing planned: No. Observational study only
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Iodine tincture in people with Peritoneal Dialysis and Peritoneal Dialysis (PD), run by Nottingham University Hospitals NHS Trust.
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 3 inclusion and 2 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: opening soon, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Jennifer C Allen, BMBS PHD (+44 01159627678, jennifer.allen36@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Oct 2026.