Closed Loop Ultrafiltration Feedback Control in Hemodialysis: A Narrative Review.

While life-sustaining, hemodialysis is a non-physiological treatment modality that exerts stress on the patient, primarily due to fluid shifts during ultrafiltration. Automated feedback control systems, integrated with sensors that continuously monitor bio-signals such as blood volume, can adjust hemodialysis treatment parameters, e.g., ultrafiltration rate, in real-time. These systems hold promise to mitigate hemodynamic stress, prevent intradialytic hypotension, and improve the removal of water and electrolytes in chronic hemodialysis patients. However, robust evidence supporting their clinical application remains limited. Based on an extensive literature research, we assess feedback-controlled ultrafiltration systems that have emerged over the past three decades in comparison to conventional hemodialysis treatment. We identified 28 clinical studies. Closed loop ultrafiltration control demonstrated effectiveness in 23 of them. No adverse effects of closed loop ultrafiltration control were reported across all trials. Closed loop ultrafiltration control represents an important advancement towards more physiological hemodialysis. Its development is driven by innovations in real-time bio-signals monitoring, advancement in control theory, and artificial intelligence. We expect these innovations will lead to the prevalent adoption of ultrafiltration control in the future, provided its clinical value is substantiated in adequately randomized controlled trials.

Testing of worn face mask and saliva for SARS-CoV-2.

Background: Exhaled SARS-CoV-2 can be detected on face masks. We compared tests for SARS-CoV-2 RNA on worn face masks and matched saliva samples. Methods: We conducted this prospective, observational, case-control study between December 2021 and March 2022. Cases comprised 30 in-center hemodialysis patients with recent COVID-19 diagnosis. Controls comprised 13 hemodialysis patients and 25 clinic staff without COVID-19 during the study period and the past 2 months. Disposable 3-layer masks were collected after being worn for 4 hours together with concurrent saliva samples. ThermoFisher COVID-19 Combo Kit (A47814) was used for RT-PCR testing. Results: Mask and saliva testing specificities were 99% and 100%, respectively. Test sensitivity was 62% for masks, and 81% for saliva (p = 0.16). Median viral RNA shedding duration was 11 days and longer in immunocompromised versus non-immunocompromised patients (22 vs. 11 days, p = 0.06, log-rank test). Conclusion: While SARS-CoV-2 testing on worn masks appears to be less sensitive compared to saliva, it may be a preferred screening method for individuals who are mandated to wear masks yet averse to more invasive sampling. However, optimized RNA extraction methods and automated procedures are warranted to increase test sensitivity and scalability. We corroborated longer viral RNA shedding in immunocompromised patients.

SARS-CoV-2 neutralizing antibody response after three doses of mRNA1273 vaccine and COVID-19 in hemodialysis patients.

Background: In hemodialysis patients, a third vaccination is frequently administered to augment protection against coronavirus disease 2019 (COVID-19). However, the newly emerged B.1.1.159 (Omicron) variant may evade vaccinal protection more easily than previous strains. It is of clinical interest to better understand the neutralizing activity against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variants after booster vaccine or COVID-19 infection in these mostly immunocompromised patients. Methods: Hemodialysis patients from four dialysis centers were recruited between June 2021 and February 2022. Each patient provided a median of six serum samples. SARS-CoV-2 neutralizing antibodies (nAbs) against wild type (WT) or Omicron were measured using the GenScript SARS-CoV-2 Surrogate Virus Neutralization Test Kit. Results: Forty-two patients had three doses of mRNA1273. Compared to levels prior to the third dose, nAb-WT increased 18-fold (peak at day 23) and nAb-Omicron increased 23-fold (peak at day 24) after the third dose. Peak nAb-WT exceeded peak nAb-Omicron 27-fold. Twenty-one patients had COVID-19 between December 24, 2021, and February 2, 2022. Following COVID-19, nAb-WT and nAb-Omicron increased 12- and 40-fold, respectively. While levels of vaccinal and post-COVID nAb-WT were comparable, post-COVID nAb-Omicron levels were 3.2 higher than the respective peak vaccinal nAb-Omicron. Four immunocompromised patients having reasons other than end-stage kidney disease have very low to no nAb after the third dose or COVID-19. Conclusions: Our results suggest that most hemodialysis patients have a strong humoral response to the third dose of vaccination and an even stronger post-COVID-19 humoral response. Nevertheless, nAb levels clearly decay over time. These findings may inform ongoing discussions regarding a fourth vaccination in hemodialysis patients.

Prevalence of fluid overload in an urban US hemodialysis population: A cross-sectional study.

INTRODUCTION: Inadequate fluid status remains a key driver of cardiovascular morbidity and mortality in chronic hemodialysis (HD) patients. Quantification of fluid overload (FO) using bioimpedance spectroscopy (BIS) has become standard in many countries. To date, no BIS device has been approved in the United States for fluid status assessment in kidney patients. Therefore, no previous quantification of fluid status in US kidney patients using BIS has been reported. Our aim was to conduct a cross-sectional BIS-based assessment of fluid status in an urban US HD population. METHODS: We determined fluid status in chronic HD patients using whole body BIS (Body Composition Monitor, BCM). The BCM reports FO in liters; negative FO denotes fluid depletion. Measurements were performed before dialysis. Post-HD FO was estimated by subtracting the intradialytic weight loss from the pre-HD FO. FINDINGS: We studied 170 urban HD patients (age 61 ± 14 years, 60% male). Pre- and post-HD FO (mean ± SD), were 2.2 ± 2.4 and -0.2 ± 2.7 L, respectively. Pre-HD, 43% of patients were fluid overloaded, 53% normally hydrated, and 4% fluid depleted. Post-HD, 12% were fluid overloaded, 55% normohydrated and 32% fluid depleted. Only 48% of fluid overloaded patients were hypertensive, while 38% were normotensive and 14% hypotensive. Fluid status did not differ significantly between African Americans (N = 90) and Caucasians (N = 61). DISCUSSION: While about half of the patients had normal fluid status pre-HD, a considerable proportion of patients was either fluid overloaded or depleted, indicating the need for tools to objectively quantify fluid status.

Transmission of SARS-CoV-2 considering shared chairs in outpatient dialysis: a real-world case-control study.

BACKGROUND: SARS-CoV-2 can remain transiently viable on surfaces. We examined if use of shared chairs in outpatient hemodialysis associates with a risk for indirect patient-to-patient transmission of SARS-CoV-2. METHODS: We used data from adults treated at 2,600 hemodialysis facilities in United States between February 1st and June 8th, 2020. We performed a retrospective case-control study matching each SARS-CoV-2 positive patient (case) to a non-SARS-CoV-2 patient (control) treated in the same dialysis shift. Cases and controls were matched on age, sex, race, facility, shift date, and treatment count. For each case-control pair, we traced backward 14 days to assess possible prior exposure from a 'shedding' SARS-CoV-2 positive patient who sat in the same chair immediately before the case or control. Conditional logistic regression models tested whether chair exposure after a shedding SARS-CoV-2 positive patient conferred a higher risk of SARS-CoV-2 infection to the immediate subsequent patient. RESULTS: Among 170,234 hemodialysis patients, 4,782 (2.8 %) tested positive for SARS-CoV-2 (mean age 64 years, 44 % female). Most facilities (68.5 %) had 0 to 1 positive SARS-CoV-2 patient. We matched 2,379 SARS-CoV-2 positive cases to 2,379 non-SARS-CoV-2 controls; 1.30 % (95 %CI 0.90 %, 1.87 %) of cases and 1.39 % (95 %CI 0.97 %, 1.97 %) of controls were exposed to a chair previously sat in by a shedding SARS-CoV-2 patient. Transmission risk among cases was not significantly different from controls (OR = 0.94; 95 %CI 0.57 to 1.54; p = 0.80). Results remained consistent in adjusted and sensitivity analyses. CONCLUSIONS: The risk of indirect patient-to-patient transmission of SARS-CoV-2 infection from dialysis chairs appears to be low.

Transmission of SARS-CoV-2 Considering Shared Chairs in Outpatient Dialysis: A Real-World Case-Control Study.

BACKGROUND: SARS-CoV-2 is primarily transmitted through aerosolized droplets; however, the virus can remain transiently viable on surfaces. OBJECTIVE: We examined transmission within hemodialysis facilities, with a specific focus on the possibility of indirect patient-to-patient transmission through shared dialysis chairs. DESIGN: We used real-world data from hemodialysis patients treated between February 1 st and June 8 th , 2020 to perform a case-control study matching each SARS-CoV-2 positive patient (case) to a non-SARS-CoV-2 patient (control) in the same dialysis shift and traced back 14 days to capture possible exposure from chairs sat in by SARS-CoV-2 patients. Cases and controls were matched on age, sex, race, facility, shift date, and treatment count. SETTING: 2,600 hemodialysis facilities in the United States. PATIENTS: Adult (age ≥18 years) hemodialysis patients. MEASUREMENTS: Conditional logistic regression models tested whether chair exposure after a positive patient conferred a higher risk of SARS-CoV-2 infection to the immediate subsequent patient. RESULTS: Among 170,234 hemodialysis patients, 4,782 (2.8%) tested positive for SARS-CoV-2 (mean age 64 years, 44% female). Most facilities (68.5%) had 0 to 1 positive SARS-CoV-2 patient. We matched 2,379 SARS-CoV-2 positive cases to 2,379 non-SARS-CoV-2 controls; 1.30% (95%CI 0.90%, 1.87%) of cases and 1.39% (95%CI 0.97%, 1.97%) of controls were exposed to a chair previously sat in by a shedding SARS-CoV-2 patient. Transmission risk among cases was not significantly different from controls (OR=0.94; 95%CI 0.57 to 1.54; p=0.80). Results remained consistent in adjusted and sensitivity analyses. LIMITATION: Analysis used real-world data that could contain errors and only considered vertical transmission associated with shared use of dialysis chairs by symptomatic patients. CONCLUSIONS: The risk of indirect patient-to-patient transmission of SARS-CoV-2 infection from dialysis chairs appears to be low. PRIMARY FUNDING SOURCE: Fresenius Medical Care North America; National Institute of Diabetes and Digestive and Kidney Diseases (R01DK130067).

Effect of Statewide Lockdown in Response to COVID-19 Pandemic on Physical Activity Levels of Hemodialysis Patients.

BACKGROUND/OBJECTIVES: On March 22, 2020, a statewide stay-at-home order for nonessential tasks was implemented in New York State. We aimed to determine the impact of the lockdown on physical activity levels (PAL) in hemodialysis patients. METHODS: Starting in May 2018, we are conducting an observational study with a 1-year follow-up on PAL in patients from 4 hemodialysis clinics in New York City. Patients active in the study as of March 22, 2020, were included. PAL was defined by steps taken per day measured by a wrist-based monitoring device (Fitbit Charge 2). Average steps/day were calculated for January 1 to February 13, 2020, and then weekly from February 14 to June 30. RESULTS: 42 patients were included. Their mean age was 55 years, 79% were males, and 69% were African Americans. Between January 1 and February 13, 2020, patients took on average 5,963 (95% CI 4,909-7,017) steps/day. In the week prior to the mandated lockdown, when a national emergency was declared, and in the week of the shutdown, the average number of daily steps had decreased by 868 steps/day (95% CI 213-1,722) and 1,222 steps/day (95% CI 668-2300), respectively. Six patients were diagnosed with COVID-19 during the study period. Five of them exhibited significantly higher PAL in the 2 weeks prior to showing COVID-19 symptoms compared to COVID-19 negative patients. CONCLUSION: Lockdown measures were associated with a significant decrease in PAL in hemodialysis patients. Patients who contracted COVID-19 had higher PAL during the incubation period. Methods to increase PAL while allowing for social distancing should be explored and implemented.