Comparative Outcome Measures of Patients Receiving Acute Renal ThErapy Study

Completed

• Conditions: End Stage Renal Disease; End Stage Kidney Disease; Acute Kidney Injury
• Interventions: Device: Intermittent Renal Replacement Therapy using Conventional Hemodialysis Systems; Device: Intermittent Renal Replacement Therapy using the Tablo Hemodialysis System

• Registration Number: NCT04912024
• Lead Sponsor: Outset Medical

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-05-15
• Study First Submitted: 2021-05-26
• Study First Submitted QC: 2021-05-28
• Study First Posted: 2021-06-03
• Primary Completion: 2022-06-15
• Study Completion: 2022-06-15
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-09
• Last Update Posted: 2022-08-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 458

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Conventional Hemodialysis System	Intermittent Renal Replacement Therapy using Conventional Hemodialysis Systems	Participants who were prescribed acute intermittent renal replacement therapy on conventional hemodialysis systems (Non-Tablo) with dialysate flow rates of ≥ 500 mL/min
Tablo Hemodialysis System	Intermittent Renal Replacement Therapy using the Tablo Hemodialysis System	Participants who were prescribed acute intermittent renal replacement therapy on the Tablo Hemodialysis System at a dialysate flow rate of 300 mL/min

Primary Outcome Measures

Name	Time	Method
BUN Lab Value	Change from baseline BUN measurement at 24 hours.	Change in Blood Urea Nitrogen

Secondary Outcome Measures

Name	Time	Method
Potassium Lab Value	Change from baseline potassium measurement at 24 hours	Change in Potassium
Bicarbonate Lab Value	Change from baseline bicarbonate measurement at 24 hours.	Change in Bicarbonate

Trial Locations

Locations (2)

Adventist Health System; 🇺🇸 Orlando, Florida, United States

Texas Health Harris Methodist Hospital Fort Worth; 🇺🇸 Fort Worth, Texas, United States