Abdominal Compartment Syndrome, Acute Kidney Injury, Cardiovascular Surgery, Intraabdominal Hypertension
Conditions
Keywords
Acute Kidney Injury (AKI), CABG, Cardiovascular Surgery, Intraabdominal Pressure (IAP), Urine Output (UO), Accuryn
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).
Interventions
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.
Sponsors
Potrero Medical
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| Temperature (T) | 30 days | Temperature (degrees Celsius) trending during hospital stay |
| Intraabdominal Hypertension (IAH) | 30 days | Intra-abdominal pressure (IAP) above 12 mm Hg (timepoint and duration) |
| Abdominal Compartment Syndrome (ACS) | 30 days | Intra-abdominal pressure (IAP) above 20 mm Hg with new organ dysfunction or failure (timepoint and duration) |
| 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) |
Countries
United States
Contacts
Primary ContactBev Ann Blackwell
Backup ContactAriane Marcus
Outcome results
None listed