Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
estimated completion
Principal Investigator
by Elaine Tseng, MD
Photo of Elaine Tseng
Elaine Tseng

Description

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.

Official Title

Physiologic Signals and Signatures With the Accuryn Monitoring System - A Retrospective and Prospective Analysis (The Accuryn Registry)

Details

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).

Keywords

Intraabdominal Hypertension Abdominal Compartment Syndrome Acute Kidney Injury Cardiovascular Surgery Acute Kidney Injury (AKI) CABG Intraabdominal Pressure (IAP) Urine Output (UO) Accuryn Compartment Syndromes Intra-Abdominal Hypertension Accuryn Monitoring System

Eligibility

You can join if…

Open to people ages 18 years and up

  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).

You CAN'T join if...

  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.

Locations

  • San Francisco VA Medical Center accepting new patients
    San Francisco California 94121 United States
  • Cedars-Sinai Medical Center accepting new patients
    Los Angeles California 90048 United States

Lead Scientist at UCSF

  • Elaine Tseng, MD
    Professor, Surgery. Authored (or co-authored) 116 research publications.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Potrero Medical
ID
NCT04669548
Study Type
Observational
Last Updated