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

Recruiting

• Conditions: Acute Kidney Injury; Abdominal Compartment Syndrome; Intraabdominal Hypertension; Cardiovascular Surgery
• Interventions: Device: Accuryn Monitoring System

• Registration Number: NCT04669548
• Lead Sponsor: Potrero Medical

Brief Summary

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).

Study Timeline

• Study First Submitted: 2020-12-09
• Study First Submitted QC: 2020-12-09
• Study First Posted: 2020-12-17
• Study Start: 2020-12-21
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-26
• Last Update Posted: 2022-09-28
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2500

Inclusion Criteria

1. 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

1. 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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Accuryn Monitoring System	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

Primary Outcome Measures

Name	Time	Method
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)
Abdominal Compartment Syndrome (ACS)	30 days	Intra-abdominal pressure (IAP) above 20 mm Hg with new organ dysfunction or failure (timepoint and duration)
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
Intraabdominal Hypertension (IAH)	30 days	Intra-abdominal pressure (IAP) above 12 mm Hg (timepoint and duration)
Temperature (T)	30 days	Temperature (degrees Celsius) trending during hospital stay
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

Trial Locations

Locations (9)

George Washington University Hospital; 🇺🇸 Washington, District of Columbia, United States

Cleveland Clinic Florida; 🇺🇸 Weston, Florida, United States

Cedars-Sinai Medical Center; 🇺🇸 Los Angeles, California, United States

Duke University Hospital; 🇺🇸 Durham, North Carolina, United States

San Francisco VA Medical Center; 🇺🇸 San Francisco, California, United States

Jewish Hospital / University of Louisville; 🇺🇸 Louisville, Kentucky, United States

Mission Health Hospital; 🇺🇸 Asheville, North Carolina, United States

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States

Wake Forest Baptist Medical Center; 🇺🇸 Winston-Salem, North Carolina, United States