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

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.