RAPPER: Relating Abdominal Complications With Peritoneal Pressure Estimation and Reporting

Sponsor

Imperial College Healthcare NHS Trust (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06060951

Collaborator

(none)

300

Enrollment

Locations

Anticipated Duration (Months)

150

Patients Per Site

6.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Peritoneal Dialysis Kidney Failure, Chronic Hernia, Abdominal	Diagnostic Test: Estimated intraperitoneal pressure

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 Design

Study Type:

Observational

Anticipated Enrollment :

300 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Oct 1, 2023

Anticipated Primary Completion Date :

Dec 31, 2024

Anticipated Study Completion Date :

Jul 31, 2025

Arms and Interventions

Arm	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: Height: measured standing with shoes off Weight: "dry weight" should be used The distance from the decubitus plane to the mid-axillary line was measured 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: Height: measured standing with shoes off Weight: "dry weight" should be used The distance from the decubitus plane to the mid-axillary line was measured 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.

Arm

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: Height: measured standing with shoes off Weight: "dry weight" should be used The distance from the decubitus plane to the mid-axillary line was measured 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

Outcome Measures

Primary Outcome Measures

Non-infectious peritoneal dialysis (PD)-related complications [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

Secondary Outcome Measures

Gastrointestinal complications [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: Abdominal pain (includes abdominal pain, hunger pains, and nausea) Reflux syndrome (covers heartburn and acid regurgitation) Diarrhoea syndrome (encompasses diarrhoea, loose stools, and urgent need for defecation) Indigestion syndrome (includes borborygmus, abdominal distension, eructation, and increased flatus) 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.
Change of dialysis modality [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.