Hemodynamic MonitoringNCT04648293
Starling Registry Study
An observational study of Hemodynamic Monitoring, run by Baxter Healthcare Corporation at 9 sites in United States.
Trial summary
Hemodynamic optimization of critically ill patients is a goal for clinicians in order to afford the patient the best possible outcomes. Being able to precisely and rapidly determine patient fluid responsiveness provides the bedside physician and nursing staff the information needed to make critical decisions in… Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Hemodynamic Monitoring
- What is being tested?
- Starling
- Type of treatment
- Medical device
- How many people
- 1,207 participants
- Where
- 9 sitesUnited States
- Study dates
- 16 Nov 2020to 21 Feb 2024
- How long will I take part?
- 30 Days
- 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 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All consecutive patients who meet the inclusion criteria within an approximate 12-24 months enrollment period will be included in the study. All patients included in this study with available data will be part of the analysis population.
Who may be able to join
- ≥18 to 95 years of age
- Patient has undergone hemodynamic monitoring with the Starling monitor
- Hemodynamic monitoring was completed no earlier than 2018
Who cannot join
- None
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Baxter Investigational Site
Camden, New Jersey, 08103
Baxter Investigational Site
Cleveland, Ohio, 44195-0001
Baxter Investigational Site
Columbus, Ohio, 43210
Baxter Investigational Site
Denver, Colorado, 80204
Baxter Investigational SIte
Galveston, Texas, 77555
Baxter Investigational Site
Kansas City, Kansas, 66160
Baxter Investigational Site
Quincy, Illinois, 62301
Baxter Investigational Site
St Louis, Missouri, 63110
Mercy Hospital St. Louis
St Louis, Missouri, 63141
About this study
Hemodynamic optimization of critically ill patients is a goal for clinicians in order to afford the patient the best possible outcomes. Being able to precisely and rapidly determine patient fluid responsiveness provides the bedside physician and nursing staff the information needed to make critical decisions in regards to the patient's fluid status and management of additional fluids and medications.
As fluid management and cardiac output determination are linked to better decision-making and improved outcomes in ICU, the use of a dynamic assessment of fluid responsiveness becomes a key tool for patient management.
This study is designed to collect treatment and outcome data on patients that have undergone hemodynamic monitoring in a wide variety of clinical settings, involving a variety of patient diagnoses.
- Conditions
- Hemodynamic Monitoring
- Being tested
- Starling
- Keywords
- Cardiac Index (CI), Stroke Volume (SV), Stroke Volume Index (SVI), Stroke Volume Variation (SVV), Heart Rate (HR), Ventricular Ejection Time (VET), Total Peripheral Resistance (TPR), Total Peripheral Resistance Index (TPRI), Cardiac Power (CP), Cardiac Power Index (CPI), Blood Oxygenation (SPO2), Oxygen Delivery Index (DO2I), Electrical impedance of the chest cavity (Z0), Thoracic Fluid Content (TFC)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
StarlingDevice
Starling is a portable, non-invasive, cardiac output detector system. The Starling monitor measures the cardiac output by employing electrical bioreactance that measures the electrical characteristics of a volume of tissue and fluid. In the case of cardiac output measurements, the relevant tissue includes the heart and the immediate surrounding volume of the thorax. The relevant fluid is blood. Baxter Healthcare's Starling electrode is a double electrode sensor. Within each sensor, one electrode is used to transmit a high frequency sine wave into the body, while the resulting voltage is measured at the adjacent electrode. Four electrodes are placed at specific areas of the thorax, the impedance to the current flow calculated, and the electrical bioreactance waveform constructed. This information is used to determine cardiac output, and measures and displays associated hemodynamic parameters based on calculations of measurements already incorporated into the Starling device.
| Study group | Role | What they receive |
|---|---|---|
| Improvement in Hemodynamics | Over the course of a patient's hospitalization, data will be collected on patients from the initiation to completion of hemodynamic monitoring with the Starling monitor in a wide variety of clinical settings, and for different diagnoses. Improvement in hemodynamics is exhibited by an increase in both Cardiac Output and Stroke Volume observed at 12 hour intervals from time of monitoring until completion. Receives: Device: Starling | |
| No Improvement in Hemodynamics | Over the course of a patient's hospitalization, data will be collected on patients from the initiation to completion of hemodynamic monitoring with the Starling monitor in a wide variety of clinical settings, and for different diagnoses. No Improvement in hemodynamics is exhibited by no increase in both Cardiac Output and Stroke Volume observed at 12 hour intervals from time of monitoring until completion. Receives: Device: Starling |
What is being measured
The primary outcome is the main question the study is designed to answer.
30 day in-hospital mortality rate
Measured: Day 1 to Day 30
Number of days on vasopressors
Measured: Day 1 to Day 30
Volume of treatment fluid administered
Measured: Time of monitoring to completion
Number of participants needing mechanical ventilation
Measured: Time of monitoring to completion
Lactate level
Measured: Time of monitoring to completion
Number of days in Intensive Care Unit (ICU)
Measured: Day 1 to Day 30
Number of days in Hospital
Measured: Day 1 to Day 30
Secondary outcomes (8)
Number of participants with COVID-19
Measured: Time of monitoring to completion
Number of participants with COVID-19 by treatment type
Measured: Time of monitoring to completion
Number of participants with COVID-19 by outcome type
Measured: Time of monitoring to completion
Percent of participants that are fluid responsive
Measured: Time of monitoring to completion
Number of participants with diastolic dysfunction
Measured: Time of monitoring to completion
Percent of participants with fluid responsiveness in diastolic dysfunction
Measured: Time of monitoring to completion
Number of participants with device related Non-Serious Adverse Events
Measured: Time of monitoring to completion
Number of participants with device related Serious Adverse Events
Measured: Time of monitoring to completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2020
- Study start16 Nov 2020
- Primary completion21 Feb 2024
- Study completion21 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemodynamic MonitoringStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,207 participants (actual)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- Baxter Healthcare Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Caio Plopper, MD, Study director, Baxter Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04648293
- Sponsor's protocol ID
- BXU553561
- Status last verified
- Apr 2024
- First submitted
- 23 Nov 2020
- Last updated
- 16 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Starling Registry Study
- ClinicalTrials.gov ID
- NCT04648293
- Acronym / sponsor ID
- BXU553561
- Conditions
- Hemodynamic Monitoring
- Keywords
- Cardiac Index (CI), Stroke Volume (SV), Stroke Volume Index (SVI), Stroke Volume Variation (SVV), Heart Rate (HR), Ventricular Ejection Time (VET), Total Peripheral Resistance (TPR), Total Peripheral Resistance Index (TPRI)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,207 participants (actual)
- Lead sponsor
- Baxter Healthcare CorporationIndustry (pharma, biotech, devices)
- Study start
- 16 Nov 2020 (actual)
- Primary completion
- 21 Feb 2024 (actual)
- Study completion
- 21 Feb 2024 (actual)
- First posted
- 1 Dec 2020 (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.
Hemodynamic optimization of critically ill patients is a goal for clinicians in order to afford the patient the best possible outcomes. Being able to precisely and rapidly determine patient fluid responsiveness provides the bedside physician and nursing staff the information needed to make critical decisions in regards to the patient's fluid status and management of additional fluids and medications.
As fluid management and cardiac output determination are linked to better decision-making and improved outcomes in ICU, the use of a dynamic assessment of fluid responsiveness becomes a key tool for patient management.
This study is designed to collect treatment and outcome data on patients that have undergone hemodynamic monitoring in a wide variety of clinical settings, involving a variety of patient diagnoses.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 30 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Improvement in Hemodynamics | – | Device: StarlingOver the course of a patient's hospitalization, data will be collected on patients from the initiation to completion of hemodynamic monitoring with the Starling monitor in a wide variety of clinical settings, and for different diagnoses. Improvement in hemodynamics is exhibited by an increase in both Cardiac Output and Stroke Volume observed at 12 hour intervals from time of monitoring until completion. |
| No Improvement in Hemodynamics | – | Device: StarlingOver the course of a patient's hospitalization, data will be collected on patients from the initiation to completion of hemodynamic monitoring with the Starling monitor in a wide variety of clinical settings, and for different diagnoses. No Improvement in hemodynamics is exhibited by no increase in both Cardiac Output and Stroke Volume observed at 12 hour intervals from time of monitoring until completion. |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All consecutive patients who meet the inclusion criteria within an approximate 12-24 months enrollment period will be included in the study. All patients included in this study with available data will be part of the analysis population.
Key inclusion criteria (3 listed)
- ≥18 to 95 years of age
- Patient has undergone hemodynamic monitoring with the Starling monitor
- Hemodynamic monitoring was completed no earlier than 2018
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| StarlingStarling is a portable, non-invasive, cardiac output detector system. The Starling monitor measures the cardiac output by employing electrical bioreactance that measures the electrical characteristics of a volume of tissue and fluid. In the case of cardiac output measurements, the relevant tissue includes the heart and the immediate surrounding volume of the thorax. The relevant fluid is blood. Baxter Healthcare's Starling electrode is a double electrode sensor. Within each sensor, one electrode is used to transmit a high frequency sine wave into the body, while the resulting voltage is measured at the adjacent electrode. Four electrodes are placed at specific areas of the thorax, the impedance to the current flow calculated, and the electrical bioreactance waveform constructed. This information is used to determine cardiac output, and measures and displays associated hemodynamic parameters based on calculations of measurements already incorporated into the Starling device. | Device | Improvement in Hemodynamics, No Improvement in Hemodynamics |
Primary outcome
30 day in-hospital mortality rate
Time frame: Day 1 to Day 30
Number of days on vasopressors
Time frame: Day 1 to Day 30
Volume of treatment fluid administered
Time frame: Time of monitoring to completion
Number of participants needing mechanical ventilation
Time frame: Time of monitoring to completion
Lactate level
Time frame: Time of monitoring to completion
Number of days in Intensive Care Unit (ICU)
Time frame: Day 1 to Day 30
Number of days in Hospital
Time frame: Day 1 to Day 30
8 secondary outcomes
Number of participants with COVID-19
Time frame: Time of monitoring to completion
Number of participants with COVID-19 by treatment type
Time frame: Time of monitoring to completion
Number of participants with COVID-19 by outcome type
Time frame: Time of monitoring to completion
Percent of participants that are fluid responsive
Time frame: Time of monitoring to completion
Number of participants with diastolic dysfunction
Time frame: Time of monitoring to completion
Percent of participants with fluid responsiveness in diastolic dysfunction
Time frame: Time of monitoring to completion
Number of participants with device related Non-Serious Adverse Events
Time frame: Time of monitoring to completion
Number of participants with device related Serious Adverse Events
Time frame: Time of monitoring to completion
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 16 Apr 2024.
- Individual participant dataSharing planned: Undecided
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Recruiting
Effects of GDHT (Goal Directed Hemodynamic Therapy) Using a Non-invasive Hemodynamic Monitoring in Elective Neurosurgery
Surgery Complications
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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.
Caio Plopper, MD study director
Baxter Healthcare
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hemodynamic Monitoring, run by Baxter Healthcare Corporation at 9 sites 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 3 inclusion and 1 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 16 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites 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?
30 day in-hospital mortality rate (time frame: Day 1 to Day 30). The study lists 7 primary outcomes in all. 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 16 Apr 2024.