Recruiting

NCT Number: NCT04669548

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.

Recruiting

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Key information

Conditions

Intraabdominal Hypertension Abdominal Compartment Syndrome Acute Kidney Injury Cardiovascular Diseases Cardiovascular Surgery Compartment Syndromes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Intra-Abdominal 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

Cedars-Sinai Medical Center, Los Angeles, California, 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 cardiac surgical intervention(s).

The secondary objective is to determine the incidence of intraoperative and postoperative intra-abdominal hypertension in the cardiovascular surgery population, analyze what factors may contribute to the development of intra-abdominal hypertension (IAH) in this patient population, and analyze associations of IAH with organ dysfunctions such as acute kidney injury and other clinical outcomes (e.g. ICU length of stay, required hemodialysis, readmission).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Signed or Verbal Informed Consent as required by IRB (if applicable).
Adult (age ≥ 18).
Monitored on the Accuryn® Monitoring System during their procedure and ICU stay (for retrospective enrollment).
Patient is undergoing cardiac surgical intervention(s).

Exclusion criteria

Known history of advanced chronic kidney disease defined by an estimated glomerular filtration rate (eGFR) <20 mL/min/1.73m2 within 30 days prior to procedure.
The patient is unsuitable for the study, in the opinion of the investigator. This may include vulnerable patient populations such as pregnant women, 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

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
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 clinician
Temperature (T)

Time frame: 30 days

Temperature (degrees Celsius) trending during hospital stay
Intraabdominal Hypertension (IAH)

Time frame: 30 days

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

Study contacts

Contact information is provided by the study sponsor or research team.

Ariane Marcus

CONTACT

[email protected]

888-635-7280

Bev Ann Blackwell

CONTACT

[email protected]

256-679-5422

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: 2020
Primary completion: 2026
Study completion: 2026
First posted: Dec 17, 2020
Registry last updated: Sep 28, 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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Completed