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NCT Number: NCT04585555

Physiologic Signals and Signatures With the Accuryn Monitoring System (The Accuryn Registry)

The Accuryn Registry Study is an open-ended, global, multi-center, retrospective and prospective, single-arm data collection study with an FDA cleared device. The target population are cardiovascular surgery patients. Physiologic data measurements will be collected from enrolled subjects using electronic medical records and data streams via the Accuryn Monitoring System.

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Key information

Conditions

Acute Kidney Injury Abdominal Compartment Syndrome Cardiovascular Diseases Cardiovascular Surgery Compartment Syndromes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Intra-Abdominal Hypertension Intraabdominal Hypertension Kidney Diseases Male Urogenital Diseases Muscular Diseases Musculoskeletal Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Emory University Hospital

Atlanta, Georgia, 30322, United States

About this study

The primary objective of the Accuryn Registry Study is to is to track and analyze changes in physiologic data streams using the Accuryn Monitoring System and correlate these changes to the occurrence of acute kidney injury (AKI) following cardiovascular surgery intervention(s).

The secondary objective is to determine the incidence of IAH and ACS in the cardiovascular surgery population and the correlation of these diagnoses to the diagnosis of AKI.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adult (age ≥ 18).
  • Monitored on the Accuryn® Monitoring System during hospital stay.
  • Patient is undergoing cardiovascular surgical intervention(s).

Exclusion criteria

  • The patient is unsuitable for the study, in the opinion of the investigator. This may include vulnerable patient populations such as prisoners or those detained in a penal institution.

Treatment and study plan

Accuryn Monitoring System

Device

The Accuryn Monitoring System is a novel Foley catheter and monitoring device capable of detecting physiologic changes in vital signs via sensors within the catheter system. These data are captured non-invasively, continuously, and at a high frequency.

Primary outcomes

  1. Urine Output (UO)

    Time frame: 30 days

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

  2. Intra-Abdominal Pressure (IAP)

    Time frame: 30 days

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

  3. Temperature (T)

    Time frame: 30 days

    Temperature (degrees Celsius) trending during hospital stay

  4. Intraabdominal Hypertension (IAH)

    Time frame: 30 days

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

  5. Abdominal Compartment Syndrome (ACS)

    Time frame: 30 days

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

  6. Acute Kidney Injury (AKI)

    Time frame: 30 days

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

Sponsors and collaborators

Lead sponsor

Potrero Medical

Industry

Registry information

Official study title

Physiologic Signals and Signatures With the Accuryn Monitoring System - A Retrospective and Prospective Analysis (The Accuryn Registry)

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Oct 14, 2020
Registry last updated
Feb 4, 2021

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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