- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02602782
Physiologic Signals and Signatures With the Accuryn™ Monitoring System in Intensive Care Patients (PRESCIENT)
September 21, 2018 updated by: Potrero Medical
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.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
76
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Significantly injured trauma ICU patients receiving a Foley catheter and transfusion
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Comparison of physiologic signals as measured by the Accuryn Monitoring System compared to existing gold standard measurements.
Time Frame: During the ICU stay (approximately 2-4 weeks)
|
During the ICU stay (approximately 2-4 weeks)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 4, 2016
Primary Completion (Actual)
January 17, 2018
Study Completion (Actual)
July 20, 2018
Study Registration Dates
First Submitted
November 10, 2015
First Submitted That Met QC Criteria
November 10, 2015
First Posted (Estimate)
November 11, 2015
Study Record Updates
Last Update Posted (Actual)
September 25, 2018
Last Update Submitted That Met QC Criteria
September 21, 2018
Last Verified
September 1, 2018
More Information
Terms related to this study
Other Study ID Numbers
- CRD-06-1346
Drug and device information, study documents
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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