Comparative Outcome Measures of Patients Receiving Acute Renal ThErapy Study

NCT ID: NCT04912024

Last Updated: 2022-08-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

458 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-05-15

Study Completion Date

2022-06-15

Brief Summary

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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

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Conditions

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End Stage Kidney Disease End Stage Renal Disease Acute Kidney Injury

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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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

Intermittent Renal Replacement Therapy using the Tablo Hemodialysis System

Intervention Type DEVICE

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

Intermittent Renal Replacement Therapy using Conventional Hemodialysis Systems

Intervention Type DEVICE

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

Interventions

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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

Intervention Type 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

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Outset Medical

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Adventist Health System

Orlando, Florida, United States

Site Status

Texas Health Harris Methodist Hospital Fort Worth

Fort Worth, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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2020-04

Identifier Type: -

Identifier Source: org_study_id

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