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

August 9, 2022 updated by: Outset Medical

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

458

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Orlando, Florida, United States, 32803
        • Adventist Health System
    • Texas
      • Fort Worth, Texas, United States, 76104
        • Texas Health Harris Methodist Hospital Fort Worth

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Participants with AKI or ESKD who were prescribed acute intermittent Renal Replacement Therapy (RRT).

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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
Conventional Hemodialysis System
Participants who were prescribed acute intermittent renal replacement therapy on conventional hemodialysis systems (Non-Tablo) with dialysate flow rates of ≥ 500 mL/min
Device: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
BUN Lab Value
Time Frame: Change from baseline BUN measurement at 24 hours.
Change in Blood Urea Nitrogen
Change from baseline BUN measurement at 24 hours.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bicarbonate Lab Value
Time Frame: Change from baseline bicarbonate measurement at 24 hours.
Change in Bicarbonate
Change from baseline bicarbonate measurement at 24 hours.
Potassium Lab Value
Time Frame: Change from baseline potassium measurement at 24 hours
Change in Potassium
Change from baseline potassium measurement at 24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Outset Medical

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 15, 2021

Primary Completion (ACTUAL)

June 15, 2022

Study Completion (ACTUAL)

June 15, 2022

Study Registration Dates

First Submitted

May 26, 2021

First Submitted That Met QC Criteria

May 28, 2021

First Posted (ACTUAL)

June 3, 2021

Study Record Updates

Last Update Posted (ACTUAL)

August 12, 2022

Last Update Submitted That Met QC Criteria

August 9, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-04

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Only aggregate data will be shared.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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