Physiologic Signals and Signatures With the Accuryn™ Monitoring System in Intensive Care Patients (PRESCIENT)

Potrero Medical

Status: Completed

Conditions: Critical Care, Intensive Care

Study type: Observational

Funder types: Industry

Identifiers

NCT02602782

CRD-06-1346

Details and patient eligibility

About

The purpose of the study is to collect physiologic data streams with the Accuryn Monitoring System and validate the accuracy of these measurements against existing gold standards, and to track and analyze changes in these physiologic data streams to identify clinical signatures that may enable earlier diagnosis and intervention of critical conditions.

Enrollment: 76 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Admission to the hospital with trauma (including burn)
• Anticipated ICU stay of at least 72 hours
• Anticipated transfusion of ≥1 unit blood products (pRBC's, platelets, and/or plasma) within the first 24 hours of hospitalization, and/or a current diagnosis of sepsis/septic shock, and/or ICU admission primarily for burn
• Anticipated requirement for a urinary bladder catheter for ≥ 72 hours

Exclusion criteria

• Inability to receive a 16F urinary bladder catheter
• Significant bladder or urethral injury
• In the opinion of the investigator the patient is unsuitable for the study for any other legitimate reason including incarceration, pre-existing medical or psychiatric condition, or interfering medications
• Known previous or concurrent enrollment in a clinical trial that, in the opinion of the investigator, might interfere with the objectives of this clinical trial
• Pregnancy known at the time of presentation