Critical Care, Intensive CarePRESCIENTNCT02602782
Physiologic Signals and Signatures With the Accuryn™ Monitoring System in Intensive Care Patients
An observational study of Critical Care, Intensive Care, run by Potrero Medical.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Care, Intensive Care
- How many people
- 76 participants
- Where
- No sites listed yet
- Study dates
- 4 Feb 2016to 20 Jul 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Significantly injured trauma ICU patients receiving a Foley catheter and transfusion
Who may be able to join
- 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
Who cannot join
- 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
About this study
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.
- Conditions
- Critical Care, Intensive Care
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of physiologic signals as measured by the Accuryn Monitoring System compared to existing gold standard measurements.
Measured: During the ICU stay (approximately 2-4 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2015 (estimated)
- Study start4 Feb 2016
- Primary completion17 Jan 2018
- Study completion20 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical Care, Intensive CareStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Potrero Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02602782
- Sponsor's protocol ID
- CRD-06-1346
- Acronym
- PRESCIENT
- Status last verified
- Sep 2018
- First submitted
- 10 Nov 2015
- Last updated
- 25 Sep 2018
- Results posted
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiologic Signals and Signatures With the Accuryn™ Monitoring System in Intensive Care Patients
- ClinicalTrials.gov ID
- NCT02602782
- Acronym / sponsor ID
- PRESCIENT / CRD-06-1346
- Conditions
- Critical Care, Intensive Care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Potrero MedicalIndustry (pharma, biotech, devices)
- Study start
- 4 Feb 2016 (actual)
- Primary completion
- 17 Jan 2018 (actual)
- Study completion
- 20 Jul 2018 (actual)
- First posted
- 11 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Significantly injured trauma ICU patients receiving a Foley catheter and transfusion
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Critical Care, Intensive Care, run by Potrero Medical.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2018.