Abstract: PO0917
Interim Analysis of the Extension of Tablo Treatment Duration (XTEND) Study
Session Information
- Leveraging Technology and Innovation to Predict Events and Improve Dialysis Delivery
November 04, 2021 | Location: On-Demand, Virtual Only
Abstract Time: 10:00 AM - 12:00 PM
Category: Dialysis
- 701 Dialysis: Hemodialysis and Frequent Dialysis
Authors
- Chahal, Yaadveer, Outset Medical, Inc., San Jose, California, United States
- Schumacher, Josh, Outset Medical, Inc., San Jose, California, United States
- Aragon, Michael A., Outset Medical, Inc., San Jose, California, United States
Background
The Tablo® Hemodialysis System (Tablo) is an all in one, easy-to-learn device featuring integrated water purification, on demand dialysate production and two-way wireless data transmission and is approved for use in the acute, chronic and home settings.
Prior reports have demonstrated Tablo’s ability to achieve clinical goals, seamlessly integrate into hospitals and reduce cost across a wide range of treatment times. Extension of the Tablo cartridge to 24 hours (extended therapy; “XT”) allows even greater flexibility for prescribers in the acute setting.
The objective is to report on the experience with Tablo extended therapy between 12 and 24 hours utilizing an interim review of the XTEND study (NCT04912050).
Methods
Nursing staff were trained during a single training session on Tablo XT. After a run-in period of 5 treatments, Tablo data were collected via real-time transmission to a cloud-based, HIPAA compliant platform and reviewed by site staff. Clinical treatment success was defined as either ending within 10% of prescribed time or site investigator assessment that all patient treatment goals were met.
Results
Fifty (50) Tablo XT treatments had a median prescribed treatment time of 24 hours and a median achieved treatment time of 23.5 hours. Median cartridge use was 1.0 per treatment. Clinical treatment success was 84%. Treatments ended due to clotting/clogging were 4% (2 of 50).
Median total ultrafiltration (UF) rate was 1.7 mL/kg/hr.
Clinically significant alarms occurred at a median rate of 7 per treatment with a resolution time of 14 seconds. Most frequent alarms experienced were arterial and venous pressure (39% and 58%, respectively), of which none resulted in an end treatment.
Conclusion
Tablo’s XT successfully achieves prescribed treatment time and favorable ultrafiltration rates with minimal therapy interruptions from alarms or cartridge changes. This data demonstrates the effectiveness of Tablo’s newly expanded versatility in achieving personalization of treatments necessary for unstable patients and enabling successful delivery of extended therapy with minimal clotting.Tablo’s 24-hour therapy meets the needs of critically ill patients that require renal replacement therapy for greater than 12 hours.
| Treatment Parameters (n=50) Median (min - max) | Treatment Outcome % (n) | Clinically Significant Alarms Median (min - max) | Alarm Type | |||||||||||||||||
| Prescribed Treatment Time (hours) | Actual Treatment Time (hours) | Cartridge Use per Treatment | Achieved UF Volume (L/treatment) | Achieved UF Rate per Treatment (mL/kg/hr) | Achieved Blood Flow Rate (mL/min) | Clinical Success (per Site Evaluation) | Treatments ended due to unresolvable alarm | Treatments interrupted for diagnostics/procedure | Treatments terminated due to clotting | Other (withdrawal of care) | Alarms per Treatment | Alarm Resolution Time (seconds) | Venous Pressure High | Arterial Pressure Low | Venous Pressure Low | Arterial Pressure High | Air in Venous Bloodline | TM Pressure | Power Failure | |
| 24.0 (24.0 - 24.0) | 23.5 (12.1 - 24.0) | 1.0 (1.0 - 3.0) | 3.9 (0.0 - 18.2) | 1.7 (0.0 - 7.1) | 150 (100 - 200) | 84% (42) | 6% (3) | 4% (2) | 4% (2) | 2% (1) | 7 (0 - 82) | 14 (5 - 116) | 46% | 36% | 12% | 3% | 1% | 1% | 1% | |
Funding
- Commercial Support – Outset Medical, Inc.