Relating Abdominal Complications With Peritoneal Pressure Estimation and Reporting

Kidney Failure, Chronic Clinical Trial

— RAPPER  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06060951
• Other study ID #: 23HH8380
• Secondary ID: 326995
• Status: Not yet recruiting
• Start date: October 1, 2023
• Est. completion date: July 31, 2025

Study information

• Verified date: September 2023
• Source: Imperial College Healthcare NHS Trust
• Contact: Richard Corbett, PhD
• Phone: +442033136647
• Email: richard.corbett[@]imperial.ac.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: July 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hernia
• Hernia, Abdominal
• Internal Hernia
• Kidney Failure, Chronic
• Peritoneal Dialysis
• Renal Insufficiency

Intervention

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.

Locations

Country	Name	City	State
United Kingdom	Birmingham Heartlands Hospital	Birmingham
United Kingdom	Hammersmith Hospital	London

Sponsors (1)

Lead Sponsor	Collaborator
Imperial College Healthcare NHS Trust

Country where clinical trial is conducted

United Kingdom, 

References & 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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: 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.	3 and 12 months following study recruitment.
Secondary	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	3 and 12 months following study recruitment.