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Clinical Evidence

Clinical
Evidence

Key Dialysis Research and Papers

Acute Usage

Study Design: St. Mark’s Hospital converted all dialysis treatments from an outside vendor (OV) to an insourced model using the Tablo Hemodialysis System. Data regarding training, user satisfaction, treatment success, and treatment costs were recorded from a total of 15 ICU, floor, and HD nurse respondents, for 577 IHD and SLEDD treatments from April through November 2020.

Results: Tablo training, set-up, and treatments were highly successful. Net savings moving to an insourced model with Tablo are projected at $450,000 in the first year (OV $650,000 vs. Tablo $200,000), and net savings per treatment is estimated at $550 (OV $800 vs. Tablo $250).

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Study Design: Compared clinical lab outcomes for patients treated on both Tablo and conventional device during their acute stay at St. Francis Hospital.

Results: 105 patients were treated on both Tablo (DFR = 300) and conventional device (DFR ≥ 500) for total of 363 treatments. BUN & K+ clearance was similar on both devices at an equal treatment time of 3.3 hours.

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Study Design: Critically ill dialysis patients were recorded for treatment results, staffing use and supply costs. Treatments ranged 4–12 hours, Qb between 100–300 mL/min and Qd between 100–300 mL/min.

Results: 37 critically ill patients had 79 treatments. 82% of treatments achieved their target dose of dialysis and UF. Treatments were at a reduced cost compared to a Non-Tablo CRRT device (65%) and a Non-Tablo IHD device (39%).

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Clinic Usage

Improved Dialysis Symptom Index with Tablo Thrice Weekly Dialysis
M. Aragon, et al., NKF Spring Clinical Conference. 2021.

Study Design: A prospective, multicenter study was conducted to evaluate “feeling better” on Tablo. Sites collected baseline laboratory, treatment and DSI data prior to conversion to Tablo. Patients completed DSIs at weeks 1, 2, 4, and 8 post conversion. Treatment and routine lab data were recorded.

Results: Of the 16 patients across 3 sites assessed on the Dialysis-Symptom Index Severity Score, Tablo patients’ average DSI was 18.1, compared to non-Tablo patients’ average DSI of 26.4. Tablo patients average DSI Symptom Burden was 6.8; non-Tablo patients’ DSI Symptom Burden was 10.6.

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Study Design: Retrospective comparative review of chronic patients’ records dialyzed in 2 clinics where Rx, URR and Kt/V were analyzed 3 months prior to Tablo and once on Tablo. 

Results: 29 chronic patients across a large weight range (52–145 kg) achieved Kt/V ≥1.2 at similar frequencies when comparing 192 treatments on Tablo at Qd = 300 mL/min versus 88 treatments on Non-Tablo at Qd = 500 mL/min on 3 times per week hemodialysis. 

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Study Design: Chronic patients dialyzed in 2 clinics with similar Rx times had their records retrospectively reviewed. Pre/ post dialysis BP, weights, and fluid removal were analyzed 3 months prior to using Tablo and once on Tablo. 

Results: 29 chronic patients on Tablo experienced BP stability in majority (66%) of 199 treatments compared to 54% in Non-Tablo treatments (109). Tablo has ↓% Systolic BP drops when compared to Non-Tablo treatments at similar treatment times (242 mins) and UF (2.6 L); 46% less in SBP drops of > 20 mmHg and 67% less in SBP drops of > 40 mmHg. 

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Home Usage

Study Design: Existing and new HHD patients were trained on Tablo by facility nursing staff. Information regarding patient demographics, treatment frequency, training time and patient satisfaction were documented. Tablo prescriptions and treatment results were obtained and recorded remotely.

Results: Conversion of an HHD program to Tablo can allow shortened training time, the ability to decrease treatment frequency while achieving adequate clearance, and result in favorable patient and nurse experience.

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Study Design: A newly diagnosed ESRD patient with interest in PD underwent an unplanned hemodialysis start. Instead of conventional treatment, the patient entered the ICSC program. After further modality education and experience with Tablo self-care, the patient decided instead to transition to home hemodialysis (HHD) with Tablo. Data regarding training, prescription, and treatments were recorded from July–October 2020.

Results: Time to Recovery (TTR) for patients was less than 2 hours in-center and at home. Patients scored themselves close to full health ( >0.825) on the EQ-5D-5L with fewer sleep symptoms and less fatigue. The Tablo ICSC model allows patients an opportunity to maintain interest in self-care even if they do not initiate treatment on a home modality. Experience with Tablo ICSC may enable successful transition to HHD with Tablo, with shorter training and high therapy adherence.

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Study Design: Prospective multi-center, open-label, non-randomized, cross-over IDE study. 30 patients from 8 dialysis units in the U.S. with ESKD treated 4x/week over 3 periods: In-Center (~8 weeks), Transition (~4 weeks), In-Home (~8 weeks). Endpoints were weekly std Kt/V ≥ 2.1, incidence of adverse events, UF goal w/in 10% of Rx. Frequency of clinically significant alarms and time to resolve was also recorded.

Results: 28 of 30 patients enrolled completed all treatment periods (>96% adherence) with 57% new to home HD. Patients completed 1806 treatments with a 3.4 hr average treatment time. All study endpoints were met; average weekly std Kt/V = 2.8 and 94% treatments were within 10% of UF goal with no Tablo related pre-specified adverse events. Both periods also had 1.3 clinically significant alarms per treatment with a median resolution time = 8 secs in-center and 5 secs at home.

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COVID-19

Use of Tablo Hemodialysis Systems to extend dialytic capabilities for the COVID-19-associated surge of AKI
Goldfarb, D. S, et al., Journal of the American Society of Nephrology. 2020.

Study Design: The COVID-19 pandemic was associated with a greater incidence of acute kidney injury (AKI) than expected. The NY Harbor VA faced an overwhelming number of AKI patients who were critically ill with multi-organ failure. They needed to invoke new mechanisms of providing kidney replacement therapy (KRT).

Results: By incorporating a user-friendly platform and an accelerated training program including nephrologists and RNs without previous dialysis experience, study authors were able to nearly double their capacity to deliver KRT during the surge.

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Study Design: During the COVID-19 pandemic, many facilities experienced dialysis resource shortages of specialized dialysis staff, sterile dialysate, dialysis systems, and dedicated treatment space. The Tablo Hemodialysis System was deployed in numerous hospitals to help meet the increased need for dialysis delivery.

Results: After standard Tablo training (<4 hours), nurses of varied experience and areas of focus reported high levels of satisfaction with their training, found Tablo easy to learn and use, and were confident in treating patients independently. Survey results were similar between Dialysis and Non-Dialysis Nurses.

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