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| Name | Class |
|---|---|
| patientMpower Ltd. | INDUSTRY |
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This is a prospective, single-arm observational study that aims to assess the validity and reproducibility of an algorithm for assessing fluid status in a cohort of dialysis patients.
The study will externally validate an existing algorithm for dry weight prediction in real-time in a cohort of dialysis patients.
Volume Overload is a contributing factor to the high rates of cardiovascular and all-cause mortality demonstrated in haemodialysis patients. At present, no method exists that can consistently refine volume status and provide patients with feedback to allow adjustments to their fluid intake. Current standards used to assess volume are either poorly predictive of fluid status, cumbersome to use, or lack an adequate patient interface.
An automated, accurate and periodic assessment of dry weight would be clinically useful, low-cost, and rapidly scalable. Machine learning methods have been widely studied in nephrology. Large amounts of precise haemodialysis data, collected and stored electronically at regular intervals, have the potential to be leveraged in the prediction of patients' extracellular volume or ideal fluid status.
A number of proof-of-concept machine-learning models for the prediction of dry weight in haemodialysis data have been created using retrospective data. This study will evaluate the usability of the machine learning models in managing fluid volume in haemodialysis patients while also assessing their validity and reproducibility against validated measurements; in this instance the Body Composition Monitor (BCM) by Fresenius.
As the machine learning model for assessing fluid status was trained and tested on retrospective data, there is sufficient justification for testing the model's performance, acceptability and usability in a controlled, observational prospective study.
This will be an 8-week trial with a 2-week run-in period conducted in a single centre in Beaumont, Dublin, Ireland. Bioimpedance measurements using the Fresenius BCM will be performed every 2 weeks. Haemodialysis data will be processed continuously throughout the trial. The algorithm will use haemodialysis data to predict the BCM output. The algorithm prediction will be compared to the BCM prediction to assess its usability.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Haemodialysis patients | Haemodialysis patients attending haemodialysis in an outpatient setting in Beaumont Hospital, Ireland. |
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| Measure | Description | Time Frame |
|---|---|---|
| The primary objective is to determine the validity of the machine learning model in estimating bioimpedance-determined dry weight in haemodialysis patients. | Dry weight (kg) estimated by the machine learning estimation model will be compared with the bioimpedance normohydration weight in kg. | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Acceptability | The acceptability of the machine learning model's outputs from a clinical healthcare perspective will be assessed.
|
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Inclusion Criteria:
Exclusion Criteria:
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Patients requiring maintenance haemodialysis in an ambulatory care setting.
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| Name | Affiliation | Role |
|---|---|---|
| O'Seaghdha | Royal College of Surgeons in Ireland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beaumont Hospital | Dublin | Leinster | 9 | Ireland | ||
| Beaumont Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33628794 | Background | Guo X, Zhou W, Lu Q, Du A, Cai Y, Ding Y. Assessing Dry Weight of Hemodialysis Patients via Sparse Laplacian Regularized RVFL Neural Network with L2,1-Norm. Biomed Res Int. 2021 Feb 4;2021:6627650. doi: 10.1155/2021/6627650. eCollection 2021. | |
| 20082919 | Background | Collins AJ, Foley RN, Herzog C, Chavers BM, Gilbertson D, Ishani A, Kasiske BL, Liu J, Mau LW, McBean M, Murray A, St Peter W, Guo H, Li Q, Li S, Li S, Peng Y, Qiu Y, Roberts T, Skeans M, Snyder J, Solid C, Wang C, Weinhandl E, Zaun D, Arko C, Chen SC, Dalleska F, Daniels F, Dunning S, Ebben J, Frazier E, Hanzlik C, Johnson R, Sheets D, Wang X, Forrest B, Constantini E, Everson S, Eggers PW, Agodoa L. Excerpts from the US Renal Data System 2009 Annual Data Report. Am J Kidney Dis. 2010 Jan;55(1 Suppl 1):S1-420, A6-7. doi: 10.1053/j.ajkd.2009.10.009. No abstract available. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 28, 2021 | Nov 18, 2022 | Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 16, 2022 | Nov 18, 2022 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D004487 | Edema |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| 8 weeks |
| Dublin |
| Leinster |
| D09V2N0 |
| Ireland |
| 32278617 | Background | Flythe JE, Chang TI, Gallagher MP, Lindley E, Madero M, Sarafidis PA, Unruh ML, Wang AY, Weiner DE, Cheung M, Jadoul M, Winkelmayer WC, Polkinghorne KR; Conference Participants. Blood pressure and volume management in dialysis: conclusions from a Kidney Disease: Improving Global Outcomes (KDIGO) Controversies Conference. Kidney Int. 2020 May;97(5):861-876. doi: 10.1016/j.kint.2020.01.046. Epub 2020 Mar 8. |
| 31367026 | Background | Tomasev N, Glorot X, Rae JW, Zielinski M, Askham H, Saraiva A, Mottram A, Meyer C, Ravuri S, Protsyuk I, Connell A, Hughes CO, Karthikesalingam A, Cornebise J, Montgomery H, Rees G, Laing C, Baker CR, Peterson K, Reeves R, Hassabis D, King D, Suleyman M, Back T, Nielson C, Ledsam JR, Mohamed S. A clinically applicable approach to continuous prediction of future acute kidney injury. Nature. 2019 Aug;572(7767):116-119. doi: 10.1038/s41586-019-1390-1. Epub 2019 Jul 31. |
| 33574056 | Background | Lee H, Yun D, Yoo J, Yoo K, Kim YC, Kim DK, Oh KH, Joo KW, Kim YS, Kwak N, Han SS. Deep Learning Model for Real-Time Prediction of Intradialytic Hypotension. Clin J Am Soc Nephrol. 2021 Mar 8;16(3):396-406. doi: 10.2215/CJN.09280620. Epub 2021 Feb 11. |