Relating Abdominal Complications With Peritoneal Pressure Estimation and Reporting

NCT06060951 | Unknown

• 2 other identifiers: 23HH8380326995
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 2

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.

Conditions

Peritoneal Dialysis; Kidney Failure, Chronic; Hernia, Abdominal

Keywords

Intraperitoneal pressure; Gastrointestinal complications; pleuroperitoneal fistulas; patent processus vaginalis; hernia

Outcome Measures

Primary Outcomes (1)

• 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

  3 and 12 months following study recruitment.

Secondary Outcomes (2)

• Gastrointestinal complications

  3 and 12 months following study recruitment.

• Change of dialysis modality

  3 and 12 months following study recruitment.

Study Arms (2)

Incident cohort

Including all patients from the time of PD catheter insertion until 8 weeks after starting PD

Diagnostic Test: Estimated intraperitoneal pressure

Prevalent cohort

Including all patients treated with PD who are greater than 8 weeks from the start of dialysis.

Diagnostic Test: Estimated intraperitoneal pressure

Interventions

Estimated intraperitoneal pressure DIAGNOSTIC_TEST

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.

Incident cohort; Prevalent cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Imperial College Healthcare NHS Trust: lead

Study Sites (2)

Birmingham Heartlands Hospital

Birmingham, B9 5SS, United Kingdom

Location

Hammersmith Hospital

London, W12 0HS, United Kingdom

Location

Related Publications (15)

• Bello AK, Okpechi IG, Osman MA, Cho Y, Cullis B, Htay H, Jha V, Makusidi MA, McCulloch M, Shah N, Wainstein M, Johnson DW. Epidemiology of peritoneal dialysis outcomes. Nat Rev Nephrol. 2022 Dec;18(12):779-793. doi: 10.1038/s41581-022-00623-7. Epub 2022 Sep 16.

  PMID: 36114414 BACKGROUND

• Leblanc M, Ouimet D, Pichette V. Dialysate leaks in peritoneal dialysis. Semin Dial. 2001 Jan-Feb;14(1):50-4. doi: 10.1046/j.1525-139x.2001.00014.x.

  PMID: 11208040 BACKGROUND

• Chan R, Walker RJ, Samaranayaka A, Schollum J. Long-term impact of early non-infectious complications at the initiation of peritoneal dialysis. Perit Dial Int. 2023 Jan;43(1):53-63. doi: 10.1177/08968608221132647. Epub 2022 Nov 3.

  PMID: 36325812 BACKGROUND

• Outerelo MC, Gouveia R, Teixeira e Costa F, Ramos A. Intraperitoneal pressure has a prognostic impact on peritoneal dialysis patients. Perit Dial Int. 2014 Sep-Oct;34(6):652-4. doi: 10.3747/pdi.2012.00192. No abstract available.

  PMID: 25228214 BACKGROUND

• Fischbach M, Terzic J, Becmeur F, Lahlou A, Desprez P, Battouche D, Geisert J. Relationship between intraperitoneal hydrostatic pressure and dialysate volume in children on PD. Adv Perit Dial. 1996;12:330-4.

  PMID: 8865930 BACKGROUND

• Fischbach M, Desprez P, Donnars F, Geisert J. Hydrostatic intraperitoneal pressure in children on peritoneal dialysis: practical implications. An 18-month clinical experience. Adv Perit Dial. 1994;10:294-6.

  PMID: 7999848 BACKGROUND

• Castellanos LB, Clemente EP, Cabanas CB, Parra DM, Contador MB, Morera JCO, Daly JA. Clinical Relevance of Intraperitoneal Pressure in Peritoneal Dialysis Patients. Perit Dial Int. 2017 Sep-Oct;37(5):562-567. doi: 10.3747/pdi.2016.00267. Epub 2017 Jul 11.

  PMID: 28698250 BACKGROUND

• Scanziani R, Dozio B, Baragetti I, Maroni S. Intraperitoneal hydrostatic pressure and flow characteristics of peritoneal catheters in automated peritoneal dialysis. Nephrol Dial Transplant. 2003 Nov;18(11):2391-8. doi: 10.1093/ndt/gfg353.

  PMID: 14551372 BACKGROUND

• de Jesus Ventura M, Amato D, Correa-Rotter R, Paniagua R. Relationship between fill volume, intraperitoneal pressure, body size, and subjective discomfort perception in CAPD patients. Mexican Nephrology Collaborative Study Group. Perit Dial Int. 2000 Mar-Apr;20(2):188-93.

  PMID: 10809242 BACKGROUND

• Li X, Ma T, Hao J, Song D, Wang H, Liu T, Zhang Y, Abi N, Xu X, Zhang M, Sun W, Li X, Dong J. Novel equations for estimating intraperitoneal pressure among peritoneal dialysis patients. Clin Kidney J. 2023 Feb 2;16(9):1447-1456. doi: 10.1093/ckj/sfad021. eCollection 2023 Sep.

  PMID: 37664572 BACKGROUND

• Dejardin A, Robert A, Goffin E. Intraperitoneal pressure in PD patients: relationship to intraperitoneal volume, body size and PD-related complications. Nephrol Dial Transplant. 2007 May;22(5):1437-44. doi: 10.1093/ndt/gfl745. Epub 2007 Feb 17.

  PMID: 17308323 BACKGROUND

• Yi C, Wang X, Ye H, Lin J, Yang X. Patient-reported gastrointestinal symptoms in patients with peritoneal dialysis: the prevalence, influence factors and association with quality of life. BMC Nephrol. 2022 Mar 9;23(1):99. doi: 10.1186/s12882-022-02723-9.

  PMID: 35264119 BACKGROUND

• Durand PY, Chanliau J, Gamberoni J, Hestin D, Kessler M. Routine measurement of hydrostatic intraperitoneal pressure. Adv Perit Dial. 1992;8:108-12.

  PMID: 1361762 BACKGROUND

• Schmitt CP, Zaloszyc A, Schaefer B, Fischbach M. Peritoneal dialysis tailored to pediatric needs. Int J Nephrol. 2011;2011:940267. doi: 10.4061/2011/940267. Epub 2011 Jun 8.

  PMID: 21761001 BACKGROUND

• Du BOIS D, Du BOIS EF. CLINICAL CALORIMETRY: TENTH PAPER A FORMULA TO ESTIMATE THE APPROXIMATE SURFACE AREA IF HEIGHT AND WEIGHT BE KNOWN. Archives of Internal Medicine. 1916;XVII(6_2): 863-871. https://doi.org/10.1001/archinte.1916.00080130010002

  BACKGROUND

MeSH Terms

Conditions

Kidney Failure, Chronic; Hernia, Abdominal; Hernia

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pathological Conditions, Anatomical

Study Officials

• Richard Corbett, PhD

  Imperial College Healthcare NHS Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Richard Corbett, PhD

CONTACT

+442033136647; richard.corbett@imperial.ac.uk

Ka Chun Leung, MRCP(UK)

CONTACT

+447838907447; kachun.leung@nhs.net

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2023
• First Posted: September 29, 2023
• Study Start: October 1, 2023
• Primary Completion: December 31, 2024
• Study Completion: July 31, 2025
• Last Updated: September 29, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• 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.

Locations

GB (2)