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| ID | Type | Description | Link |
|---|---|---|---|
| 326995 | Other Identifier | IRAS |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Incident cohort | Including all patients from the time of PD catheter insertion until 8 weeks after starting PD |
| |
| Prevalent cohort | Including all patients treated with PD who are greater than 8 weeks from the start of dialysis. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Estimated intraperitoneal pressure | Diagnostic Test | The following anthropometric measurements are required:
The estimated IPP will be assessed using different equations. |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
| 3 and 12 months following study recruitment. |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
We also track the number of participants referred for surgical fixation of non-infectious PD-related complications. |
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Inclusion Criteria:
Exclusion Criteria:
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All patients with kidney failure treated with peritoneal dialysis are eligible.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Richard Corbett, PhD | Contact | +442033136647 | 36647 | richard.corbett@imperial.ac.uk |
| Ka Chun Leung, MRCP(UK) | Contact | +447838907447 | kachun.leung@nhs.net |
| Name | Affiliation | Role |
|---|---|---|
| Richard Corbett, PhD | Imperial College Healthcare NHS Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham Heartlands Hospital | Birmingham | B9 5SS | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36114414 | Background | 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. | |
| 11208040 | 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. |
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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.
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.
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.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 21, 2023 | Sep 27, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 11, 2023 | Sep 27, 2023 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| D046449 | Hernia, Abdominal |
| D006547 | Hernia |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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|
| 3 and 12 months following study recruitment. |
| 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. |
| Hammersmith Hospital | London | W12 0HS | United Kingdom |
|
| 36325812 | 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. |
| 25228214 | 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. |
| 8865930 | 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. |
| 7999848 | 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. |
| 28698250 | 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. |
| 14551372 | 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. |
| 10809242 | 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. |
| 37664572 | 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. |
| 17308323 | 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. |
| 35264119 | 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. |
| 1361762 | Background | Durand PY, Chanliau J, Gamberoni J, Hestin D, Kessler M. Routine measurement of hydrostatic intraperitoneal pressure. Adv Perit Dial. 1992;8:108-12. |
| 21761001 | 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. |
| 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 |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020763 | Pathological Conditions, Anatomical |