Multiple-frequency bioimpedance devices for fluid management in people with chronic kidney disease receiving dialysis: a systematic review and economic evaluation

Abstract

BackgroundChronic kidney disease (CKD) is a long-term condition requiring treatment such as conservative management, kidney transplantation or dialysis. To optimise the volume of fluid removed during dialysis (to avoid underhydration or overhydration), people are assigned a ‘target weight’, which is commonly assessed using clinical methods, such as weight gain between dialysis sessions, pre- and post-dialysis blood pressure and patient-reported symptoms. However, these methods are not precise, and measurement devices based on bioimpedance technology are increasingly used in dialysis centres. Current evidence on the role of bioimpedance devices for fluid management in people with CKD receiving dialysis is limited.ObjectivesTo evaluate the clinical effectiveness and cost-effectiveness of multiple-frequency bioimpedance devices versus standard clinical assessment for fluid management in people with CKD receiving dialysis.Data sourcesWe searched major electronic databases [e.g. MEDLINE, MEDLINE In-Process & Other Non-Indexed Citations, EMBASE, Science Citation Index and Cochrane Central Register of Controlled Trials (CENTRAL)] conference abstracts and ongoing studies. There were no date restrictions. Searches were undertaken between June and October 2016.Review methodsEvidence was considered from randomised controlled trials (RCTs) comparing fluid management by multiple-frequency bioimpedance devices and standard clinical assessment in people receiving dialysis, and non-randomised studies evaluating the use of the devices for fluid management in people receiving dialysis. One reviewer extracted data and assessed the risk of bias of included studies. A second reviewer cross-checked the extracted data. Standard meta-analyses techniques were used to combine results from included studies. A Markov model was developed to assess the cost-effectiveness of the interventions.ResultsFive RCTs (with 904 adult participants) and eight non-randomised studies (with 4915 adult participants) assessing the use of the Body Composition Monitor [(BCM) Fresenius Medical Care, Bad Homburg vor der Höhe, Germany] were included. Both absolute overhydration and relative overhydration were significantly lower in patients evaluated using BCM measurements than for those evaluated using standard clinical methods [weighted mean difference –0.44, 95% confidence interval (CI) –0.72 to –0.15,p = 0.003,I2 = 49%; and weighted mean difference –1.84, 95% CI –3.65 to –0.03;p = 0.05,I2 = 52%, respectively]. Pooled effects of bioimpedance monitoring on systolic blood pressure (SBP) (mean difference –2.46 mmHg, 95% CI –5.07 to 0.15 mmHg;p = 0.06,I2 = 0%), arterial stiffness (mean difference –1.18, 95% CI –3.14 to 0.78;p = 0.24,I2 = 92%) and mortality (hazard ratio = 0.689, 95% CI 0.23 to 2.08;p = 0.51) were not statistically significant. The economic evaluation showed that, when dialysis costs were included in the model, the probability of bioimpedance monitoring being cost-effective ranged from 13% to 26% at a willingness-to-pay threshold of £20,000 per quality-adjusted life-year gained. With dialysis costs excluded, the corresponding probabilities of cost-effectiveness ranged from 61% to 67%.LimitationsLack of evidence on clinically relevant outcomes, children receiving dialysis, and any multifrequency bioimpedance devices, other than the BCM.ConclusionsBCM used in addition to clinical assessment may lower overhydration and potentially improve intermediate outcomes, such as SBP, but effects on mortality have not been demonstrated. If dialysis costs are not considered, the incremental cost-effectiveness ratio falls below £20,000, with modest effects on mortality and/or hospitalisation rates. The current findings are not generalisable to paediatric populations nor across other multifrequency bioimpedance devices.Future workServices that routinely use the BCM should report clinically relevant intermediate and long-term outcomes before and after introduction of the device to extend the current evidence base.Study registrationThis study is registered as PROSPERO CRD42016041785.FundingThe National Institute for Health Research Health Technology Assessment programme.

Impact of extracellular-to-intracellular fluid volume ratio on albuminuria in patients with type 2 diabetes: A cross-sectional and retrospective cohort study

“…Previous study show that both human and animals with volume overload have significantly higher pro-inflammatory cytokines such as IL-6 or TNF-α (38), which can be the result of kidney endothelial dysfunction and impairment of TGF. Further, inflammation-induced hypoalbuminemia and increased vascular permeability enhance extravascular fluid shift, thereby resulting in ECF volume overload (13). In fact, the ECW/TBW ratio, which is substantially the same as the ECW/ICW ratio, has been used as a marker of ECW excess (8,39,40).…”

“…One of the mechanism of fluid overload is thought to be inflammation, which causes hypoalbuminemia and increased vascular permeability (12). The result is extravascular fluid shift which leads to ECF volume overload (13). We hypothesized that subtle fluid imbalance occurs in patients with diabetes mellitus without kidney failure, and that there is an association between fluid imbalance and albuminuria.…”

NT-proBNP in the Prognosis of Death or Need for Renal Replacement Therapy in Patients with Stage 3–5 Chronic Kidney Disease

“…In another study, NT-proBNP was also an independent predictor of mortality among patients who received peritoneal dialysis [25]. Of all renal replacement therapies, peritoneal dialysis is characterized by the highest risk of hyper­hydration; thus, NT-proBNP seems to have a particularly significant prognostic value in this group of patients [26]. …”

Systematic Fluid Assessment in Haemodialysis: Development and Validation of A Decision Aid

“…It is important to recognise BIS is adding information to an already complex decision‐making process, rather than providing a simple target applicable to all patients (Scotland et al . ; Tabinor & Davies ). Clinical guidelines for target weight determination are lacking (Hecking et al .…”

“…Evidence of the impact of BIS-guided fluid management on survival is still lacking (Covic et al 2017) and one limitation of the current adoption of this technology is the use of it in isolation rather than as a part of clinical assessment. It is important to recognise BIS is adding information to an already complex decision-making process, rather than providing a simple target applicable to all patients (Scotland et al 2018;Tabinor & Davies 2018). Clinical guidelines for target weight determination are lacking (Hecking et al 2015;Dasgupta et al 2016), and there is a need for the development of a decision aid that helps clinicians incorporate the information from BIS when setting target weights (Weiner et al 2014;Tabinor & Davies 2018).…”