Accuryn Monitoring System for Cardiac Surgery Patients

This study is looking at how the Accuryn Monitoring System, a special Foley catheter with sensors, can help monitor vital signs in patients undergoing heart surgery. The system continuously collects data to see if changes in these vital signs are linked to problems like acute kidney injury (AKI) or high pressure in the belly (intra-abdominal hypertension). Researchers will also explore what might cause this high pressure and its connection to other health issues. You might be able to join if you are an adult (18 or older) having heart surgery and will be monitored with the Accuryn system. The study aims to track your urine output, intra-abdominal pressure, and temperature for 30 days.

Study design
This is an observational study, meaning researchers will collect data from 2500 participants who are already using the Accuryn Monitoring System. It is a single-arm study, so all participants will receive the same monitoring.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your urine output, intra-abdominal pressure, and temperature will be measured for 30 days.

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NCT04669548

Physiologic Signals and Signatures With the Accuryn Monitoring System - The Accuryn Registry

Recruiting
Not specifiedAges 18+Observational
Potrero Medical
~2,500 participants
Updated 2022-09-28 on ClinicalTrials.gov
What's tested:Accuryn Monitoring System

At a glance

Recruiting sites
6 of 9 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Urine Output (UO)
Measured over 30 days
+5 more outcomes measured
Intraabdominal Hypertension
Abdominal Compartment Syndrome
Acute Kidney Injury
Cardiovascular Surgery
9 sites across 6 states
North Carolina3
California2
District of Columbia1
Florida1
Kentucky1
Ohio1
  • Vanessa Moll, MD, PhD · STUDY_DIRECTOR · Potrero Medical

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  • Urine Output (UO)30 days

    High accuracy Urine Output (mL/hour) while on a urinary catheter, and estimated UO while not on a urinary catheter

  • Intra-Abdominal Pressure (IAP)30 days

    Intra-Abdominal Pressure (mmHg) trending while on a urinary catheter, as well as active measurements taken by clinician clinician

  • Temperature (T)30 days

    Temperature (degrees Celsius) trending during hospital stay

  • Intraabdominal Hypertension (IAH)30 days

    Intra-abdominal pressure (IAP) above 12 mm Hg (timepoint and duration)

  • Abdominal Compartment Syndrome (ACS)30 days

    Intra-abdominal pressure (IAP) above 20 mm Hg with new organ dysfunction or failure (timepoint and duration)

  • Acute Kidney Injury (AKI)30 days

    % of patients diagnosed with AKI, and hospitalization day of diagnosis. AKI diagnosed per KDIGO criteria (Stage 1 to 3)