An observational study in Peritoneal Dialysis, Kidney Failure, Chronic and Hernia, Abdominal, sponsored by Imperial College Healthcare NHS Trust. Not yet recruiting at 2 sites in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-09-29.
Sponsored by Imperial College Healthcare NHS Trust · Observational
This is a prospective observational study in people treated with peritoneal dialysis for kidney failure to investigate whether estimated intraperitoneal pressure (eIPP) is correlated with non-infectious PD-related complications in end-stage renal failure patients. It looks to understand how both peritoneal dialysis complications (including fluid leaks and hernias) along with gastrointestinal symptoms are associated with eIPP in people treated with PD.
Peritoneal dialysis is an important treatment option for kidney failure. It involves the instillation of fluid into the peritoneal cavity. The choice of volume of fluid used has a limited evidence base but will be between 1 liter to 2.5 liters depending on clinical preference. The intraperitoneal pressure (IPP) that results from this fluid varies widely between patients. However, IPP is difficult to implement clinically. There is some evidence that higher IPP is associated with an increased rate of non-infectious PD complications. These complications are mainly leaks (escape of peritoneal fluid from the peritoneal cavity) and hernias.
New methods for estimating IPP (eIPP) have been recently developed but not validated clinically. This study looks to the association of eIPP and non-infectious PD complications as well as understanding whether there is an association between eIPP and patients' burden of symptoms.
This is an observational study, no changes to fill volume or treatment will result from the eIPP. Clinicians and nurses involved in the care of the patient will not receive feedback on the eIPP measurement. This simple study will look to recruiting patients with informed consent. Those who agree to enter the study will have a small number of non-invasive measurements made at the time of a routine clinic visit. A short survey will also be administered both at the initial visit, along with 3 and 12 months later. The research team, will review the patients' notes at 12 months following recruitment for evidence of non-infectious PD-related complications.
This research proposal has informed by interaction with people with lived experience. The scientific rationale has been tested by a discussion with experts in PD in other centres.
Given that this is an observational study, individuals will not be exposed to increased clinical risk through the alteration of PD fill volume or novel procedures. The greatest burden for participants will be the completion of three short, validated survey questionnaires over 12 months.
Confidentiality will be maintained with the use of pseudonymisation to maintain participants confidentiality.
2,108 studies on the registry are indexed under Kidney Failure, Chronic; 273 are open to participants now.
This study's planned enrollment of 300 is above the median of 120 across 442 observational studies indexed under Kidney Failure, Chronic.
Browse Kidney Failure, Chronic studies →Imperial College Healthcare NHS Trust is the lead sponsor of 80 studies on the registry; 19 are open to participants now.
Counted across the registry records on this site, refreshed daily.
All patients with kidney failure treated with peritoneal dialysis are eligible.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Including all patients from the time of PD catheter insertion until 8 weeks after starting PD
Diagnostic Test: Estimated intraperitoneal pressure
Including all patients treated with PD who are greater than 8 weeks from the start of dialysis.
Diagnostic Test: Estimated intraperitoneal pressure
The following anthropometric measurements are required: 1. Height: measured standing with shoes off 2. Weight: "dry weight" should be used 3. The distance from the decubitus plane to the mid-axillary line was measured 4. Waist circumference: measured with a tape measure wrapped above the iliac crests around the level of the umbilicus. The estimated IPP will be assessed using different equations.
Non-infectious peritoneal dialysis (PD)-related complications
Incidence of non-infectious peritoneal dialysis (PD)-related complications identified by the clinical team caring for the patient including the development of a new: * Hernia * Pleuroperitoneal fistula (PPF) * Patent processus vaginalis (PPV) * Retroperitoneal leak
Time frame: 3 and 12 months following study recruitment.
Gastrointestinal complications
Patient-reported outcome changes on the Gastrointestinal Symptom Rating Scale (GSRS) questionnaire: GSRS is a 15-item interview-based scale, each rated on a 7-point Likert scale (1-7), higher scores indicating worse symptoms. GSRS items fall into five scales: 1. Abdominal pain (includes abdominal pain, hunger pains, and nausea) 2. Reflux syndrome (covers heartburn and acid regurgitation) 3. Diarrhoea syndrome (encompasses diarrhoea, loose stools, and urgent need for defecation) 4. Indigestion syndrome (includes borborygmus, abdominal distension, eructation, and increased flatus) 5. Constipation syndrome (covers constipation, hard stools, and feeling of incomplete evacuation) Scores are calculated as the mean of completed items within each scale (min score: 1, max score: 7), higher scores indicating more severe symptoms. We also track the number of participants referred for surgical fixation of non-infectious PD-related complications.
Time frame: 3 and 12 months following study recruitment.
Change of dialysis modality
Number of Participants with modality change to automated peritoneal dialysis (APD) Number of Participants with transferring to haemodialysis due to non-infectious complications
Time frame: 3 and 12 months following study recruitment.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — The Chief Investigator will preserve the confidentiality of participants taking part in the study and is registered under the Data Protection Act. Participants' information will be pseudonymized when possible. Only the pseudonymized form of data will be shared with researchers from other organizations, such as universities, National Health Service (NHS) organizations, or companies involved in health and care research in the UK or abroad, in compliance with ethical and legal requirements. Data collection, storage, and analysis will comply with data protection regulations, including the UK General Data Protection Regulation (UK GDPR) and the Data Protection Act 2018. All participants' information will be stored securely and analyzed using a local computer with strict arrangements for access and use, ensuring that the information is used only for health and care research or to contact participants about future research opportunities. No cloud service will be involved.
Supporting information: Study protocol, Informed consent form
Time frame: Patients' personal data will be stored in the local electronic patient management system as this is part of their follow- up and clinical care. Results of descriptive statistics or data analysis will be stored for 5 years.
Access criteria: Only the pseudonymized form of data will be shared with researchers from other organizations, such as universities, NHS organizations, or companies involved in health and care research in the UK or abroad, in compliance with ethical and legal requirements.
This study is not yet recruiting, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Imperial College Healthcare NHS Trust