Physiologic Signals and Signatures With the Accuryn Monitoring System - The Accuryn Registry
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Accuryn Monitoring System.
- Who it may be relevant to
- Registry conditions: Intraabdominal Hypertension, Abdominal Compartment Syndrome, Acute Kidney Injury, Cardiovascular Surgery. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Physiologic Signals and Signatures With the Accuryn Monitoring System - A Retrospective and Prospective Analysis (The Accuryn Registry)
Overview
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.
Detailed description
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).
Interventions
- Device Accuryn Monitoring System
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 outcome measures
- Urine Output (UO) [Time frame: 30 days]
- Intra-Abdominal Pressure (IAP) [Time frame: 30 days]
- Temperature (T) [Time frame: 30 days]
- Intraabdominal Hypertension (IAH) [Time frame: 30 days]
- Abdominal Compartment Syndrome (ACS) [Time frame: 30 days]
- Acute Kidney Injury (AKI) [Time frame: 30 days]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
United States · 9 centers
- Cedars-Sinai Medical Center — Los Angeles
- San Francisco VA Medical Center — San Francisco
- George Washington University Hospital — Washington D.C.
- Cleveland Clinic Florida — Weston
- Jewish Hospital / University of Louisville — Louisville
- Mission Health Hospital — Asheville
- Duke University Hospital — Durham
- Wake Forest Baptist Medical Center — Winston-Salem
- … and 1 more center
Publications
- Khanna AK, Minear S, Kurz A, Moll V, Stanton K, Essakalli L, Prabhakar A; Predict AKI Group. Intra-abdominal hypertension in cardiac surgery patients: a multicenter observational sub-study of the Accuryn registry. J Clin Monit Comput. 2023 Feb;37(1):189-199. doi: 10.1007/s10877-022-00878-2. Epub 2022 Jun 13. PMID 35695943
Identifiers
NCT: NCT04669548 · CRD-06-101904