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NCT04912024 Clinical Trial

Comparative Outcome Measures of Patients Receiving Acute Renal ThErapy Study

Acute Kidney Injury Clinical Trial

— COMPARE  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04912024
Other study ID # 2020-04
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 15, 2021
Est. completion date June 15, 2022

Study information
Verified date August 2022
Source Outset Medical
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 458
Est. completion date June 15, 2022
Est. primary completion date June 15, 2022
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Device:
• Intermittent Renal Replacement Therapy using the Tablo Hemodialysis System
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 Systems
Intermittent renal replacement therapy using Conventional Hemodialysis Systems in the acute setting for participants with AKI or ESKD

Locations
Country Name City State
United States Texas Health Harris Methodist Hospital Fort Worth Fort Worth Texas
United States Adventist Health System Orlando Florida

Sponsors (1)
Lead Sponsor Collaborator
Outset Medical

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary BUN Lab Value Change in Blood Urea Nitrogen Change from baseline BUN measurement at 24 hours.
Secondary Bicarbonate Lab Value Change in Bicarbonate Change from baseline bicarbonate measurement at 24 hours.
Secondary Potassium Lab Value Change in Potassium Change from baseline potassium measurement at 24 hours
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