Blood PressureVERBATIMNCT06253780
Multidisciplinary Study to Verify Blood Pressure Documentation and Response to Titration of Intravenous Medications
An observational study of Blood Pressure, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
This study is an observational, non-randomized, study that will examine the variability in blood pressure (BP) response to intravenous (IV) vasoactive medications when BP is continuously sampled versus real-world BP sampling. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Blood Pressure
- Type of treatment
- Injection or infusion
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jan 2024to 31 Jan 2025
- 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: Study personnel will identify NSICU patients who are receiving an IV vasoactive medication infusion and are scheduled to have an arterial line (A-line) placed, or already have an A-line placed. This information is found in the EMR. Following consent, the study team will assign each patient a subject identification number (SID) that will be used as an alternate to any protected health information (PHI). After consent has been given, the study team will coordinate a time to place the CNS-200 monitor in the room of the patient. In the NSICU, the SOC is to routinely test BP using a cuff and or A-line.
Who may be able to join
- 18 years old or older
- Admitted to the NSICU at UT Southwestern Medical Center with a neurological, neurosurgical, or neurovascular diagnosis
- Patients must be receiving Intravenous vasoactive medication infusing at the time of consent
- Eligible patients must have an indwelling A-line as placed as part of standard of care
- Patients, or legally authorized representatives, must be able to consent themselves in English.
Who cannot join
- Under the age of 18
- Pregnant
- Incarcerated upon admission to ICU
Trial locations and contacts
1 site in 1 country.
About this study
This study is an observational, non-randomized, study that will examine the variability in blood pressure (BP) response to intravenous (IV) vasoactive medications when BP is continuously sampled versus real-world BP sampling. Continuous BP sampling will be obtained using the Component Neuromonitoring System (CNS-200; Natus Corp) to obtain continuous data acquisition (CDA). The investigators will explore BP change based on electronic medical record (EMR) vs CNS-200 data. This study will consent and observe 30 Neuroscience Intensive Care Unit subjects using pragmatic sampling. Each subject will be observed one-and-only-one time for a 12-hour period.
Read the detailed description
In this study, the investigators seek to explore if patients who receive continuous IV vasoactive medication infusion have a difference in blood pressure (BP) response measured and reported continuously versus intermittently. Adult patients (age > 18 years old) admitted to the Neuroscience Intensive Care Unit at The University of Texas Southwestern Medical Center with a neurological, neurosurgical, or neurovascular diagnosis are eligible. Patients must be receiving Intravenous vasoactive medication infusing at the time of consent. Eligible patients must have an indwelling Arterial line as placed as part of standard of care. There are no restrictions on obtaining Non-invasive BP during data collection. Patients, or legally authorized representatives (LARs), must be able to consent themselves in English. Subjects will be excluded if they are: Under the age of 18, pregnant, or they are currently incarcerated. Because the study does not have the availability to develop foreign language consents, subjects (or LARs) who are unable to read and communicate in English will also be excluded. The primary null hypothesis is that continuously acquired data from the arterial line have a similar mean and standard deviation as documented values in the EMR. The first step in examining this hypothesis is a simple paired T-test. An F-test will be used to compare the standard deviations. Rejection of the null will indicate the need for additional models to compare the median, Interquartile range (IQR), minimum and maximum values. The area under the curve will be determined as a function of the time above or below the prescribed BP range and the time spent outside of that range.
- Conditions
- Blood Pressure
- Keywords
- neurovascular illness, Neurocritical care, Blood pressure, Continuous data acquisition, Neurology, Neurosurgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Adult patients (age > 18 years old) admitted to the NSICU at UT Southwestern Medical Center with a neurological, neurosurgical, or neurovascular diagnosis are eligible receiving Intravenous vasoactive medication infusing at the time of consent. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reported blood pressure reliability
This study is an observational, non-randomized, study that will examine the variability in blood pressure (BP) response to intravenous vasoactive medications when BP is continuously sampled versus real-world BP sampling. Continuous BP sampling will be obtained using the Component Neuromonitoring System (CNS-200; Natus Corp) to obtain Continuous data acquisition (CDA) data. The investigators will explore BP change based on Electronic Medical Record (EMR) vs CNS-200 (CDA) data.
Measured: 12-hour monitoring session once per enrolled patient (baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2024
- Study start12 Jan 2024
- Primary completion1 May 2024
- Study completion31 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood PressureStudies 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Chiesi USA, Inc.
- Responsible party
- Principal investigator, DaiWai Olson, University of Texas Southwestern Medical Center
- Investigators
- DaiWai M Olson, PhD, RN, FNCS, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06253780
- Sponsor's protocol ID
- 3034
- Acronym
- VERBATIM
- Status last verified
- Feb 2025
- First submitted
- 30 Jan 2024
- Last updated
- 21 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multidisciplinary Study to Verify Blood Pressure Documentation and Response to Titration of Intravenous Medications
- ClinicalTrials.gov ID
- NCT06253780
- Acronym / sponsor ID
- VERBATIM / 3034
- Conditions
- Blood Pressure
- Keywords
- neurovascular illness, Neurocritical care, Blood pressure, Continuous data acquisition, Neurology, Neurosurgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Collaborators
- Chiesi USA, Inc.
- Study start
- 12 Jan 2024 (actual)
- Primary completion
- 1 May 2024 (actual)
- Study completion
- 31 Jan 2025 (actual)
- First posted
- 12 Feb 2024 (actual)
- 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.
This study is an observational, non-randomized, study that will examine the variability in blood pressure (BP) response to intravenous (IV) vasoactive medications when BP is continuously sampled versus real-world BP sampling. Continuous BP sampling will be obtained using the Component Neuromonitoring System (CNS-200; Natus Corp) to obtain continuous data acquisition (CDA). The investigators will explore BP change based on electronic medical record (EMR) vs CNS-200 data. This study will consent and observe 30 Neuroscience Intensive Care Unit subjects using pragmatic sampling. Each subject will be observed one-and-only-one time for a 12-hour period.
Detailed description
In this study, the investigators seek to explore if patients who receive continuous IV vasoactive medication infusion have a difference in blood pressure (BP) response measured and reported continuously versus intermittently. Adult patients (age > 18 years old) admitted to the Neuroscience Intensive Care Unit at The University of Texas Southwestern Medical Center with a neurological, neurosurgical, or neurovascular diagnosis are eligible. Patients must be receiving Intravenous vasoactive medication infusing at the time of consent. Eligible patients must have an indwelling Arterial line as placed as part of standard of care. There are no restrictions on obtaining Non-invasive BP during data collection. Patients, or legally authorized representatives (LARs), must be able to consent themselves in English. Subjects will be excluded if they are: Under the age of 18, pregnant, or they are currently incarcerated. Because the study does not have the availability to develop foreign language consents, subjects (or LARs) who are unable to read and communicate in English will also be excluded. The primary null hypothesis is that continuously acquired data from the arterial line have a similar mean and standard deviation as documented values in the EMR. The first step in examining this hypothesis is a simple paired T-test. An F-test will be used to compare the standard deviations. Rejection of the null will indicate the need for additional models to compare the median, Interquartile range (IQR), minimum and maximum values. The area under the curve will be determined as a function of the time above or below the prescribed BP range and the time spent outside of that range.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | –Adult patients (age > 18 years old) admitted to the NSICU at UT Southwestern Medical Center with a neurological, neurosurgical, or neurovascular diagnosis are eligible receiving Intravenous vasoactive medication infusing at the time of consent. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study personnel will identify NSICU patients who are receiving an IV vasoactive medication infusion and are scheduled to have an arterial line (A-line) placed, or already have an A-line placed. This information is found in the EMR. Following consent, the study team will assign each patient a subject identification number (SID) that will be used as an alternate to any protected health information (PHI). After consent has been given, the study team will coordinate a time to place the CNS-200 monitor in the room of the patient. In the NSICU, the SOC is to routinely test BP using a cuff and or A-line.
Key inclusion criteria (5 listed)
- 18 years old or older
- Admitted to the NSICU at UT Southwestern Medical Center with a neurological, neurosurgical, or neurovascular diagnosis
- Patients must be receiving Intravenous vasoactive medication infusing at the time of consent
- Eligible patients must have an indwelling A-line as placed as part of standard of care
- Patients, or legally authorized representatives, must be able to consent themselves in English.
Key exclusion criteria (3 listed)
- Under the age of 18
- Pregnant
- Incarcerated upon admission to ICU
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
Reported blood pressure reliability
Time frame: 12-hour monitoring session once per enrolled patient (baseline)
This study is an observational, non-randomized, study that will examine the variability in blood pressure (BP) response to intravenous vasoactive medications when BP is continuously sampled versus real-world BP sampling. Continuous BP sampling will be obtained using the Component Neuromonitoring System (CNS-200; Natus Corp) to obtain Continuous data acquisition (CDA) data. The investigators will explore BP change based on Electronic Medical Record (EMR) vs CNS-200 (CDA) data.
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 21 Feb 2025.
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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.
DaiWai M Olson, PhD, RN, FNCS principal investigator
University of Texas Southwestern Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Blood Pressure, run by University of Texas Southwestern Medical Center at 1 site in United States.
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 5 inclusion and 3 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 21 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Reported blood pressure reliability (time frame: 12-hour monitoring session once per enrolled patient (baseline)). 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 21 Feb 2025.