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Physiologic Signals and Signa...

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

Last Updated: 2018-09-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

76 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-02-04

Study Completion Date

2018-07-20

Brief Summary

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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.

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Detailed Description

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Conditions

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Critical Care, Intensive Care

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers