EXtension of Tablo TrEatmeNt Duration Registry

Completed

• Conditions: Acute Kidney Injury; End Stage Renal Disease (ESRD); End Stage Renal Disease on Dialysis

• Registration Number: NCT04912050
• Lead Sponsor: Outset Medical

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-05-25
• Study First Submitted: 2021-05-26
• Study First Submitted QC: 2021-05-28
• Study First Posted: 2021-06-03
• Primary Completion: 2022-05-31
• Study Completion: 2022-05-31
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-09
• Last Update Posted: 2022-08-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Treatment Success	Up to 24 hours	Percentage of treatments achieving prescribed dialysis treatment time ≤ 10%

Secondary Outcome Measures

Name	Time	Method
Tablo Cartridge Life	up to 24 hours	Measure the average number of cartridge changes required to complete a Tablo XT Treatment

Trial Locations

Locations (1)

St. Mark's Hospital; 🇺🇸 Salt Lake City, Utah, United States