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Completed

NCT Number: NCT04912024

Comparative Outcome Measures of Patients Receiving Acute Renal ThErapy Study

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

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Key information

Conditions

End Stage Kidney Disease Acute Kidney Injury Chronic Disease Disease Attributes End Stage Renal Disease Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Adventist Health System, Orlando, Florida, United States

Loading trial locations.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Intermittent Renal Replacement Therapy using the Tablo Hemodialysis System

Device

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

Device

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

Primary outcomes

  1. BUN Lab Value

    Time frame: Change from baseline BUN measurement at 24 hours.

    Change in Blood Urea Nitrogen

Secondary outcomes

  1. Bicarbonate Lab Value

    Time frame: Change from baseline bicarbonate measurement at 24 hours.

    Change in Bicarbonate

  2. Potassium Lab Value

    Time frame: Change from baseline potassium measurement at 24 hours

    Change in Potassium

Sponsors and collaborators

Lead sponsor

Outset Medical

Industry

Registry information

Official study title

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

Acronym: COMPARE

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jun 3, 2021
Registry last updated
Aug 12, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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