Comparative Outcome Measures of Patients Receiving Acute Renal ThErapy Study

NCT04912024 | Completed FDA Device

• 1 other identifier: 2020-04
• Study Type: observational
• Target: 458
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

End Stage Kidney Disease; End Stage Renal Disease; Acute Kidney Injury

Keywords

Tablo; Outset Medical; ESRD; AKI

Outcome Measures

Primary Outcomes (1)

• BUN Lab Value

  Change in Blood Urea Nitrogen

  Change from baseline BUN measurement at 24 hours.

Secondary Outcomes (2)

• Bicarbonate Lab Value

  Change from baseline bicarbonate measurement at 24 hours.

• Potassium Lab Value

  Change from baseline potassium measurement at 24 hours

Study Arms (2)

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

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

Interventions

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

Tablo Hemodialysis System

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

Conventional Hemodialysis System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• Treatments isolated to ultrafiltration only.

Sponsors & Collaborators

• Outset Medical: lead

Study Sites (2)

Adventist Health System

Orlando, Florida, 32803, United States

Location

Texas Health Harris Methodist Hospital Fort Worth

Fort Worth, Texas, 76104, United States

Location

MeSH Terms

Conditions

Kidney Failure, Chronic; Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2021
• First Posted: June 3, 2021
• Study Start: May 15, 2021
• Primary Completion: June 15, 2022
• Study Completion: June 15, 2022
• Last Updated: August 12, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)