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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

Study Design: Chronic patients performing self-care on Tablo at 4 dialysis units were monitored to record time to set up disposables. Alarm frequency, alarm type, and time required to resolve alarms was also recorded.

Results: Tablo experience with 20 chronic patients in over 356 treatments show 90% of patients set-up disposables in < 5 mins. Average alarm rate was 1.3 alarms per treatment with an average resolution time of 22 seconds. 

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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: 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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Study Design: Secondary Analysis of IDE

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. 

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Self-care training using the Tablo hemodialysis system
T. Plumb, et al., “HDI”, 2020

Study Design: Secondary Analysis of IDE

Results: Patients were able to setup and initiate treatment in less than 20 minutes. Healthcare providers found patients self competent in under 4 sessions (16 hours). Patients rated Tablo as simple to use and were able to treat independently on Tablo. 

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