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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02602782
Recruitment Status : Completed
First Posted : November 11, 2015
Last Update Posted : September 25, 2018
Sponsor:
Information provided by (Responsible Party):
Potrero Medical

Brief Summary:
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.

Condition or disease
Critical Care, Intensive Care

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Study Type : Observational
Actual Enrollment : 76 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Physiologic Signals and Signatures With the Accuryn™ Monitoring System in Intensive Care Patients
Actual Study Start Date : February 4, 2016
Actual Primary Completion Date : January 17, 2018
Actual Study Completion Date : July 20, 2018



Primary Outcome Measures :
  1. 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) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Significantly injured trauma ICU patients receiving a Foley catheter and transfusion
Criteria

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
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Responsible Party: Potrero Medical
ClinicalTrials.gov Identifier: NCT02602782    
Other Study ID Numbers: CRD-06-1346
First Posted: November 11, 2015    Key Record Dates
Last Update Posted: September 25, 2018
Last Verified: September 2018

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Studies a U.S. FDA-regulated Device Product: No