Physiologic Signals and Signatures With the Accuryn Monitoring System - The Accuryn Registry
Purpose
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.
Conditions
- Intraabdominal Hypertension
- Abdominal Compartment Syndrome
- Acute Kidney Injury
- Cardiovascular Surgery
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Signed or Verbal Informed Consent as required by IRB (if applicable). 2. Adult (age ≥ 18). 3. Monitored on the Accuryn® Monitoring System during their procedure and ICU stay (for retrospective enrollment). 4. 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. 2. 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.
Study Design
- Phase
- Study Type
- Observational
- Observational Model
- Case-Only
- Time Perspective
- Prospective
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
| Accuryn Monitoring System | Observational only (no intervention). Patients undergoing cardiovascular surgical intervention(s) monitored with the Accuryn Monitoring System (per standard of care) during their hospital stay |
|
Recruiting Locations
Washington D.C. 4140963, District of Columbia 4138106 20037
Weston 4178003, Florida 4155751 33331
Louisville 4299276, Kentucky 6254925 40202
Asheville 4453066, North Carolina 4482348 28803
Durham 4464368, North Carolina 4482348 27710
Cleveland 5150529, Ohio 5165418 44195
More Details
- Status
- Recruiting
- Sponsor
- Potrero Medical
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).