Protocol of a pilot-scale, single-arm, observational study to assess the utility and acceptability of a wearable hydration monitor in haemodialysis patients

Vicki Sandys, Colin Edwards, Paul McAleese, Emer O'Hare, Conall O'Seaghdha, Vicki Sandys, Colin Edwards, Paul McAleese, Emer O'Hare, Conall O'Seaghdha

Abstract

Background: Fluid overload has a high prevalence in haemodialysis patients and is an important risk factor for excess mortality and hospitalisations. Despite the risks associated with chronic fluid overload, it is clinically difficult to assess and maintain fluid status adequately. Current methods of fluid status assessment are either imprecise or time intensive. In particular, to date, no method exists to accurately assess fluid status during the interdialytic interval.

Objectives: This pilot study aimed to evaluate whether a prototype wearable hydration monitor can accurately and reproducibly detect fluid overload in the haemodialysis population when compared to haemodialysis and bioimpedance data.

Methods: A prospective, open-label, single-arm observational trial of 20 patients commenced in January 2021 in a single haemodialysis centre in Ireland, with a wearable hydration monitor, the Sixty device. The Sixty device uses diffuse reflectance spectroscopy to measure fluid levels at the level of the subdermis and uses machine learning to develop an algorithm that can determine fluid status. The Sixty device was worn at every dialysis session and nocturnally over a three-week observational period. Haemodialysis parameters including interdialytic weight gain, ultrafiltration volume, blood pressure, and relative blood volume were collected from each session, and bioimpedance measurements using the Fresenius body composition monitor were performed on 4 occasions as a comparator. The primary objective of this trial was to determine the accuracy and reproducibility of the Sixty device compared to bioimpedance measurements.

Conclusion: If the accuracy of the wearable hydration monitor is validated, further studies will be conducted to integrate the device output into a multi-parameter machine learning algorithm that can provide patients with actionable insights to manage fluid overload in the interdialytic period.

Trial registration: www.clinicaltrials.gov NCT04623281 . Registered November 10th, 2020.

Conflict of interest statement

The authors declare that they have no competing interests.

© 2022. The Author(s).

Figures

Fig. 1
Fig. 1
Diagram of trial design
Fig. 2
Fig. 2
Photographs of prototype and expected final design of the Sixty device

References

    1. Collins AJ, Foley RN, Gilbertson DT, Chen S-C. United States Renal Data System public health surveillance of chronic kidney disease and end-stage renal disease. Kidney Int Suppl. 2015;5:2–7. doi: 10.1038/kisup.2015.2.
    1. Kalantar-Zadeh K, Regidor DL, Kovesdy CP, Van Wyck D, Bunnapradist S, Horwich TB, et al. Fluid retention is associated with cardiovascular mortality in patients undergoing long-term hemodialysis. Circulation. 2009;119(5):671–679. doi: 10.1161/CIRCULATIONAHA.108.807362.
    1. Inrig JK, Patel UD, Gillespie BS, Hasselblad V, Himmelfarb J, Reddan D, et al. Relationship between interdialytic weight gain and blood pressure among prevalent hemodialysis patients. Am J Kidney Dis. 2007;50(1):108–118. doi: 10.1053/j.ajkd.2007.04.020.
    1. Pabst S, Hammerstingl C, Hundt F, Gerhardt T, Grohé C, Nickenig G, et al. Pulmonary hypertension in patients with chronic kidney disease on dialysis and without dialysis: results of the PEPPER-study. PLoS One. 2012;7(4):e35310. doi: 10.1371/journal.pone.0035310.
    1. McCullough PA, Chan CT, Weinhandl ED, Burkart JM, Bakris GL. Intensive hemodialysis, left ventricular hypertrophy, and cardiovascular disease. Am J Kidney Dis. 2016;68(5S1):S5–14. doi: 10.1053/j.ajkd.2016.05.025.
    1. Arneson TJ, Liu J, Qiu Y, Gilbertson DT, Foley RN, Collins AJ. Hospital treatment for fluid overload in the Medicare hemodialysis population. Clin J Am Soc Nephrol. 2010;5(6):1054–1063. doi: 10.2215/CJN.00340110.
    1. Zoccali C, Moissl U, Chazot C, Mallamaci F, Tripepi G, Arkossy O, et al. Chronic fluid overload and mortality in ESRD. J Am Soc Nephrol. 2017;28(8):2491–2497. doi: 10.1681/ASN.2016121341.
    1. Flythe JE, Kimmel SE, Brunelli SM. Rapid fluid removal during dialysis is associated with cardiovascular morbidity and mortality. Kidney Int. 2011;79(2):250–257. doi: 10.1038/ki.2010.383.
    1. Wabel P, Moissl U, Chamney P, Jirka T, Machek P, Ponce P, et al. Towards improved cardiovascular management: the necessity of combining blood pressure and fluid overload. Nephrol Dial Transplant. 2008;23(9):2965–2971. doi: 10.1093/ndt/gfn228.
    1. Torino C, Gargani L, Sicari R, Letachowicz K, Ekart R, Fliser D, et al. The agreement between auscultation and lung ultrasound in hemodialysis patients: the LUST study. Clin J Am Soc Nephrol. 2016;11(11):2005–2011. doi: 10.2215/CJN.03890416.
    1. Agarwal R, Andersen MJ, Pratt JH. On the importance of pedal edema in hemodialysis patients. Clin J Am Soc Nephrol. 2008;3(1):153–158. doi: 10.2215/CJN.03650807.
    1. Loutradis C, Papadopoulos CE, Sachpekidis V, Ekart R, Krunic B, Karpetas A, et al. Lung ultrasound-guided dry weight assessment and echocardiographic measures in hypertensive hemodialysis patients: a randomized controlled study. Am J Kidney Dis. 2020;75(1):11–20. doi: 10.1053/j.ajkd.2019.07.025.
    1. Flythe JE, Chang TI, Gallagher MP, Lindley E, Madero M, Sarafidis PA, et al. Blood pressure and volume management in dialysis: conclusions from a Kidney Disease: Improving Global Outcomes (KDIGO) controversies conference. Kidney Int. 2020;97(5):861–876. doi: 10.1016/j.kint.2020.01.046.
    1. Wabel P, Chamney P, Moissl U, Jirka T. Importance of whole-body bioimpedance spectroscopy for the management of fluid balance. Blood Purif. 2009;27(1):75–80. doi: 10.1159/000167013.
    1. Schoutteten MK, Vranken J, Lee S, Smeets CJP, De Cannière H, Van Hoof C, et al. Towards personalized fluid monitoring in haemodialysis patients: thoracic bioimpedance signal shows strong correlation with fluid changes, a cohort study. BMC Nephrol. 2020;21(1):264. doi: 10.1186/s12882-020-01922-6.
    1. toSenseTM. Accessed 30 Sep 2020.
    1. Kidney Health Initiative. . Accessed 10 May 2021.
    1. Kraemer M, Rode C, Wizemann V. Detection limit of methods to assess fluid status changes in dialysis patients. Kidney Int. 2006;69(9):1609–1620. doi: 10.1038/sj.ki.5000286.
    1. Chamney PW, Wabel P, Moissl UM, Müller MJ, Bosy-Westphal A, Korth O, et al. A whole-body model to distinguish excess fluid from the hydration of major body tissues. Am J Clin Nutr. 2007;85(1):80–89. doi: 10.1093/ajcn/85.1.80.
    1. Siriopol D, Siriopol M, Stuard S, Voroneanu L, Wabel P, Moissl U, et al. An analysis of the impact of fluid overload and fluid depletion for all-cause and cardiovascular mortality. Nephrol Dial Transplant. 2019;34(8):1385–1393. doi: 10.1093/ndt/gfy396.
    1. Hur E, Usta M, Toz H, Asci G, Wabel P, Kahvecioglu S, et al. Effect of fluid management guided by bioimpedance spectroscopy on cardiovascular parameters in hemodialysis patients: a randomized controlled trial. Am J Kidney Dis. 2013;61(6):957–965. doi: 10.1053/j.ajkd.2012.12.017.
    1. Scotland G, Cruickshank M, Jacobsen E, Cooper D, Fraser C, Shimonovich M, et al. Multiple-frequency bioimpedance devices for fluid management in people with chronic kidney disease receiving dialysis: a systematic review and economic evaluation. Health Technol Assess. 2018;22(1):1–138. doi: 10.3310/hta22010.
    1. Beaubien-Souligny W, Kontar L, Blum D, Bouchard J, Denault AY, Wald R. Meta-analysis of randomized controlled trials using tool-assisted target weight adjustments in chronic dialysis patients. Kidney Int Rep. 2019;4(10):1426–1434. doi: 10.1016/j.ekir.2019.07.003.

Source: PubMed

Sponsorit ja yhteistyökumppanit

Sairaudet

Huumeiden interventiot

3
Tilaa