Relating Abdominal Complications With Peritoneal Pressure Estimation and Reporting
NCT ID: NCT06060951
Last Updated: 2023-09-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
300 participants
OBSERVATIONAL
2023-10-01
2025-07-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Incident cohort
Including all patients from the time of PD catheter insertion until 8 weeks after starting PD
Estimated intraperitoneal pressure
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.
Prevalent cohort
Including all patients treated with PD who are greater than 8 weeks from the start of dialysis.
Estimated intraperitoneal pressure
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.
Interventions
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Estimated intraperitoneal pressure
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* Inability or unwillingness to comply with study procedures.
18 Years
ALL
No
Sponsors
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Imperial College Healthcare NHS Trust
OTHER
Responsible Party
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Principal Investigators
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Richard Corbett, PhD
Role: PRINCIPAL_INVESTIGATOR
Imperial College Healthcare NHS Trust
Locations
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Birmingham Heartlands Hospital
Birmingham, , United Kingdom
Hammersmith Hospital
London, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Jyoti Baharani, FRCP(UK)
Role: primary
Richard Corbett, PhD
Role: primary
Ka Chun Leung, MRCP(UK)
Role: backup
References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Durand PY, Chanliau J, Gamberoni J, Hestin D, Kessler M. Routine measurement of hydrostatic intraperitoneal pressure. Adv Perit Dial. 1992;8:108-12.
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.
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
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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326995
Identifier Type: OTHER
Identifier Source: secondary_id
23HH8380
Identifier Type: -
Identifier Source: org_study_id