Relating Abdominal Complications With Peritoneal Pressure Estimation and Reporting (RAPPER)

September 27, 2023 updated by: Imperial College Healthcare NHS Trust

To Investigate the Relationship Between Estimated Intraperitoneal Pressure and Non-infectious Peritoneal Dialysis (PD)-Related Abdominal Complications

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Estimated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United Kingdom
      • Birmingham, United Kingdom, B9 5SS
        • Birmingham Heartlands Hospital
        • Contact:
        • Principal Investigator:
          • Jyoti Baharani, FRCP(UK)
      • London, United Kingdom, W12 0HS
        • Hammersmith Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Richard Corbett, PhD
        • Sub-Investigator:
          • Ka Chun Leung, MRCP(UK)
        • Sub-Investigator:
          • Edwina Brown, DM (Oxon)
        • Sub-Investigator:
          • Gaetano Lucisano, PhD
        • Sub-Investigator:
          • Frank Dor, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

All patients with kidney failure treated with peritoneal dialysis are eligible.

Description

Inclusion Criteria:

  • Age 18 years or older
  • Diagnosis of end-stage renal failure requiring peritoneal dialysis as renal replacement therapy
  • Ability to give informed consent and comply with study procedures.

Exclusion Criteria:

  • Known allergy or hypersensitivity to any component of the dialysis solution.
  • Inability or unwillingness to comply with study procedures.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Incident cohort
Including all patients from the time of PD catheter insertion until 8 weeks after starting PD
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.
Prevalent cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Non-infectious peritoneal dialysis (PD)-related complications
Time Frame: 3 and 12 months following study recruitment.

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
3 and 12 months following study recruitment.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gastrointestinal complications
Time Frame: 3 and 12 months following study recruitment.

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.
3 and 12 months following study recruitment.
Change of dialysis modality
Time Frame: 3 and 12 months following study recruitment.
Number of Participants with modality change to automated peritoneal dialysis (APD) Number of Participants with transferring to haemodialysis due to non-infectious complications
3 and 12 months following study recruitment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Imperial College Healthcare NHS Trust

Investigators

  • Principal Investigator: Richard Corbett, PhD, Imperial College Healthcare NHS Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2023

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

July 31, 2025

Study Registration Dates

First Submitted

September 21, 2023

First Submitted That Met QC Criteria

September 27, 2023

First Posted (Actual)

September 29, 2023

Study Record Updates

Last Update Posted (Actual)

September 29, 2023

Last Update Submitted That Met QC Criteria

September 27, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23HH8380
  • 326995 (Other Identifier: IRAS)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing 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.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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