Acute Kidney Injury, End Stage Kidney Disease, End Stage Renal Disease
Conditions
Keywords
Tablo, Outset Medical, ESRD, AKI
Brief summary
Retrospective, multicenter, comparative, post-market study of the Tablo Hemodialysis System in hospitalized participants with End-Stage Renal Disease or Acute Kidney Injury.
Interventions
DEVICEIntermittent Renal Replacement Therapy using the Tablo Hemodialysis System
Intermittent renal replacement therapy using the Tablo Hemodialysis System in the acute setting for participants with AKI or ESKD
DEVICEIntermittent Renal Replacement Therapy using Conventional Hemodialysis Systems
Intermittent renal replacement therapy using Conventional Hemodialysis Systems in the acute setting for participants with AKI or ESKD
Sponsors
Outset Medical
Study design
Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Inclusion criteria
* Participant is 18 years of age. * Participant weighs ≥ 34kg. * Participant was hospitalized and had dialysis dependent End-Stage Renal Disease or Acute Kidney Injury and was prescribed acute intermittent renal replacement therapy.
Exclusion criteria
* Treatments isolated to ultrafiltration only. * Any documented condition the Physician feels would prevent the participant from successful inclusion in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| BUN Lab Value | Change from baseline BUN measurement at 24 hours. | Change in Blood Urea Nitrogen |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Bicarbonate Lab Value | Change from baseline bicarbonate measurement at 24 hours. | Change in Bicarbonate |
| Potassium Lab Value | Change from baseline potassium measurement at 24 hours | Change in Potassium |
Countries
United States
Outcome results
None listed