Comparative Outcome Measures of Patients Receiving Acute Renal ThErapy Study

N/ACompletedNCT04912024

Outset Medical458 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

458

Conditions

End Stage Kidney Disease End Stage Renal Disease Acute Kidney Injury

Interventions

Intermittent Renal Replacement Therapy using the Tablo Hemodialysis SystemDEVICE

Intermittent renal replacement therapy using the Tablo Hemodialysis System in the acute setting for participants with AKI or ESKD

Intermittent Renal Replacement Therapy using Conventional Hemodialysis SystemsDEVICE

Intermittent renal replacement therapy using Conventional Hemodialysis Systems in the acute setting for participants with AKI or ESKD

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (2)

Adventist Health System

Orlando, Florida, United States

Texas Health Harris Methodist Hospital Fort Worth

Fort Worth, Texas, United States

Outcomes

Primary Outcomes

BUN Lab Value

Change in Blood Urea Nitrogen

Time frame: Change from baseline BUN measurement at 24 hours.

Secondary Outcomes

Bicarbonate Lab Value

Change in Bicarbonate

Time frame: Change from baseline bicarbonate measurement at 24 hours.

Potassium Lab Value

Change in Potassium

Time frame: Change from baseline potassium measurement at 24 hours

Data from ClinicalTrials.gov

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