Clinical trial NCT06060951: Relating Abdominal Complications With Peritoneal Pressure Estimation and Reporting
Official title: To Investigate the Relationship Between Estimated Intraperitoneal Pressure and Non-infectious Peritoneal Dialysis (PD)-Related Abdominal Complications
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Peritoneal Dialysis
Kidney Failure, Chronic
Hernia, Abdominal
Keywords: Intraperitoneal pressure
Gastrointestinal complications
pleuroperitoneal fistulas
patent processus vaginalis
hernia
Lead sponsor: Imperial College Healthcare NHS Trust
Sponsor class: OTHER
First posted: 2023-09-29
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients with kidney failure treated with peritoneal dialysis are eligible.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Non-infectious peritoneal dialysis (PD)-related complications
timeFrame: 3 and 12 months following study recruitment.
Secondary outcomes:
measure: Gastrointestinal complications
timeFrame: 3 and 12 months following study recruitment.
measure: Change of dialysis modality
timeFrame: 3 and 12 months following study recruitment.
Other outcomes:
Locations:
city: Birmingham
country: United Kingdom
facility: Birmingham Heartlands Hospital
city: London
country: United Kingdom
facility: Hammersmith Hospital
Study officials:
affiliation: Imperial College Healthcare NHS Trust
name: Richard Corbett, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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