Clinical trial NCT04669548: Physiologic Signals and Signatures With the Accuryn Monitoring System - The Accuryn Registry
Official title: Physiologic Signals and Signatures With the Accuryn Monitoring System - A Retrospective and Prospective Analysis (The Accuryn Registry)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Intraabdominal Hypertension
Abdominal Compartment Syndrome
Acute Kidney Injury
Cardiovascular Surgery
Keywords: Acute Kidney Injury (AKI)
CABG
Cardiovascular Surgery
Intraabdominal Pressure (IAP)
Urine Output (UO)
Accuryn
Lead sponsor: Potrero Medical
Sponsor class: INDUSTRY
First posted: 2020-12-17
Enrollment: 2500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing cardiovascular surgical intervention(s) who meet eligibility criteria and are monitored with the Accuryn Monitoring System throughout their procedure and intensive care unit (ICU) stay.

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Urine Output (UO)
timeFrame: 30 days
measure: Intra-Abdominal Pressure (IAP)
timeFrame: 30 days
measure: Temperature (T)
timeFrame: 30 days
measure: Intraabdominal Hypertension (IAH)
timeFrame: 30 days
measure: Abdominal Compartment Syndrome (ACS)
timeFrame: 30 days
measure: Acute Kidney Injury (AKI)
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: San Francisco
country: United States
facility: San Francisco VA Medical Center
state: California
city: Washington
country: United States
facility: George Washington University Hospital
state: District of Columbia
city: Weston
country: United States
facility: Cleveland Clinic Florida
state: Florida
city: Louisville
country: United States
facility: Jewish Hospital / University of Louisville
state: Kentucky
city: Asheville
country: United States
facility: Mission Health Hospital
state: North Carolina
city: Durham
country: United States
facility: Duke University Hospital
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Medical Center
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
affiliation: Potrero Medical
name: Vanessa Moll, MD, PhD
role: STUDY_DIRECTOR
References:
citation: 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.