Comparative Outcome Measures of Patients Receiving Acute Renal ThErapy Study (COMPARE)

Outset Medical

Status: Completed

Conditions: Acute Kidney Injury; End Stage Renal Disease; End Stage Kidney Disease

Treatments: Device: Intermittent Renal Replacement Therapy using Conventional Hemodialysis Systems; Device: Intermittent Renal Replacement Therapy using the Tablo Hemodialysis System

Study type: Observational

Funder types: Industry

Identifiers

NCT04912024

2020-04

Details and patient eligibility

About

Retrospective, multicenter, comparative, post-market study of the Tablo Hemodialysis System in hospitalized participants with End-Stage Renal Disease or Acute Kidney Injury.

Enrollment: 458 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

458 participants in 2 patient groups

Tablo Hemodialysis System

Description:

Participants who were prescribed acute intermittent renal replacement therapy on the Tablo Hemodialysis System at a dialysate flow rate of 300 mL/min

Treatment:

Device: Intermittent Renal Replacement Therapy using the Tablo Hemodialysis System

Conventional Hemodialysis System

Description:

Participants who were prescribed acute intermittent renal replacement therapy on conventional hemodialysis systems (Non-Tablo) with dialysate flow rates of ≥ 500 mL/min

Treatment:

Device: Intermittent Renal Replacement Therapy using Conventional Hemodialysis Systems