Bremnes Frida, Øien Cecilia Montgomery, Kvaerness Jørn, Jaatun Ellen Andreassen, Aas Sigve Nyvik, Saether Terje, Lund Henrik, Romundstad Solfrid
Mode Sensors AS, Trondheim, Norway.
Department of Nephrology, St. Olavs Hospital, Trondheim, Norway.
BMC Nephrol. 2025 Jan 8;26(1):14. doi: 10.1186/s12882-024-03929-9.
Accurate assessment of fluid volume and hydration status is essential in many disease states, including patients with chronic kidney disease. The aim of this study was to investigate the ability of a wearable continuous bioimpedance sensor to detect changes in fluid volume in patients undergoing regular hemodialysis (HD).
31 patients with end-stage renal disease were enrolled and monitored with a sensor patch (Re:Balans) on the upper back through two consecutive HD sessions and the interdialytic period between. The extracellular resistance R was calculated from multi-frequency bioimpedance measurements and was hypothesized to correlate with the amount of extracted fluid during dialysis.
Only HD sessions with a positive net fluid extraction were included in the primary analysis. Participants had an increase of 7.5 ± 4.3 Ω (Ohm) in R during the first HD and 6.2 ± 2.3 Ω during the second HD, and a fluid extraction (ultrafiltration (UF) volume) of 1.5 ± 0.8 L and 1.2 ± 0.6 L, respectively. The relative change in R during HD correlated strongly with UF volume (r = 0.82, p < 0.001). During the interdialytic period, the patients had a mean decrease in R of 6.0 ± 3.5 Ω. Longitudinal changes in R (%) and body weight (kg) over the entire study period was negatively correlated (r = -0.61 p < 0.001). Longitudinal changes in blood samples and cardiovascular changes were also in agreement with changes in weight and R.
The results of this clinical investigation indicate that the investigational device is capable of tracking both rapid and gradual changes in hydration status in patients undergoing regular HD.
准确评估液体量和水合状态在许多疾病状态下至关重要，包括慢性肾脏病患者。本研究的目的是调查一种可穿戴连续生物阻抗传感器检测接受定期血液透析（HD）患者液体量变化的能力。
招募31例终末期肾病患者，通过两个连续的HD疗程及其间的透析间期，使用背部上方的传感器贴片（Re:Balans）进行监测。通过多频生物阻抗测量计算细胞外电阻R，并假设其与透析期间抽取的液体量相关。
主要分析仅纳入净液体抽取为正的HD疗程。参与者在第一次HD期间R增加7.5±4.3Ω（欧姆），第二次HD期间增加6.2±2.3Ω，液体抽取量（超滤（UF）量）分别为1.5±0.8L和1.2±0.6L。HD期间R的相对变化与UF量密切相关（r = 0.82，p < 0.001）。在透析间期，患者R平均下降6.0±3.5Ω。整个研究期间R（%）和体重（kg）的纵向变化呈负相关（r = -0.61，p < 0.001）。血液样本的纵向变化和心血管变化也与体重和R的变化一致。
这项临床研究结果表明，该研究装置能够追踪接受定期HD患者水合状态的快速和逐渐变化。
