Acute Kidney Injury, End Stage Renal Disease (ESRD), End Stage Renal Disease on Dialysis
Conditions
Keywords
Tablo, Outset Medical, Hemodialysis, AKI, ESKD
Brief summary
Observational, retrospective and prospective, multicenter, post-market study of the Tablo Hemodialysis System in hospitalized participants with End-Stage Kidney Disease or Acute Kidney Injury who are prescribed renal replacement therapy \> 12 hours.
Interventions
Renal Replacement Therapy between 12\< to ≤ 24 hours.
Sponsors
Outset Medical
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Participant weighs ≥ 34kg. * Participant is hospitalized and has dialysis dependent End-Stage Kidney Disease or Acute Kidney Injury and is prescribed renal replacement therapy \> 12 hours.
Exclusion criteria
* Any documented condition that the Physician feels would prevent the participant from successful inclusion in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment Success | Up to 24 hours | Percentage of treatments achieving prescribed dialysis treatment time ≤ 10% |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tablo Cartridge Life | up to 24 hours | Measure the average number of cartridge changes required to complete a Tablo XT Treatment |
Countries
United States
Outcome results
None listed