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OpenTrials
Completed

NCT Number: NCT02602782

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

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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Key information

Conditions

Critical Care, Intensive Care

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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)

Sponsors and collaborators

Lead sponsor

Potrero Medical

Industry

Registry information

Acronym: PRESCIENT

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Nov 11, 2015
Registry last updated
Sep 25, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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