The EvAluation of TaBlo In-CLinic and In-HOme

Outset Medical30 enrolled

Overview

The purpose of this study is to evaluate the Tablo Hemodialysis System when used In-Center by trained individuals and In-Home by trained Subjects.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

End Stage Renal Disease

Interventions

Tablo Hemodialysis SystemDEVICE

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Subject has end stage renal disease (ESRD) adequately treated by maintenance dialysis achieving a Kt/V ≥ 1.2 and has been deemed stable for at least three months by his/her treating nephrologist. * Subject has a well-functioning and stable vascular access that allows a blood flow of at least 300 ml/min. Exclusion Criteria: * Life expectancy less than 12 months from first study procedure. * Subject has had a recent major cardiovascular adverse event within the last 3 months. * Subject has New York Class III or IV Congestive Heart Failure, or ejection fraction less than 30%. * Subject with fluid overload due to intractable ascites secondary to liver cirrhosis. * Subject has uncontrolled blood pressure. * Subject is intolerant to heparin. * Subject is seroreactive for Hepatitis B Surface Antigen. * Subject has an active, life-threatening, rheumatologic disease. * Subject has a history of adverse reactions to dialyzer membrane material. * Subject is expected to receive an organ transplant during the course of the study. * Subject has a life-threatening malignancy actively receiving treatment that would prevent successful completion of the study protocol.

Locations (1)

Outset Medical

San Jose, California, United States

Outcomes

Primary Outcomes

Weekly Standardized Dialysis Adequacy

Weekly standardized dialysis adequacy (stdKt/V) was measured using the second-generation formula of Daugirdas. This formula normalizes urea clearance among heterogeneous hemodialysis schedules, where K=dialyzer clearance or urea, t=treatment time, and V=subject's volume of urea distribution. stdKt/V values of ≥ 2.1 are regarded as being adequate.

Time frame: 8 weeks per period

Incidence of Pre-Specified Adverse Events

All adverse events (AEs) observed in the trial were reviewed by an independent Clinical Events Committee (CEC). AEs adjudicated into the following pre-specified categories were included in the outcome measure: 1. Serious Adverse Event 2. Allergic Reaction: to dialyzer, blood tubing or chemical disinfectant. 3. Blood Loss: that leads to death, transfusion or fluid resuscitation with greater than 1 liter of crystalloid IV fluids. 4. Hemolytic Reaction: due to disinfectant exposure, dialysate temperature, mechanical failure or other device related causes. 5. Infection: any infection related to catheter, its tunnel or exit site, AV fistula, or AV graft. 6. Intra-Dialysis Event: a significant clinical event such as loss of consciousness, cardiac arrest, or seizure caused by device failure. 7. Vascular Access Complications 8. Pyrogenic Reaction

Time frame: 8 weeks per period

Secondary Outcomes

Ultrafiltration Rate Success

The Ultrafiltration (UF) rate was calculated using the following method: UF rate = (Fluid Removal Goal + Rinse Back Volume) / Treatment Duration. Where: Fluid Removal Goal = (Today's Weight - Prescribed Estimated Dry Weight) And: Rinse Back Volume = The volume of saline, 300mL, returned to the patient at the end of treatment. Each dialysis treatment was flagged as a success with respect to UF if the actual UF rate was within 10% of the prescribed UF rate. The mean (i.e., success proportion) and standard deviation were computed by treatment period across all subjects, where the denominator for the mean calculations was the total number of treatments in each treatment period for which the subjects contributed non-missing UF data.

Time frame: 8 weeks per period

Data from ClinicalTrials.gov

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