Hemodynamic MonitoringNCT05729048
Starling/CRRT Observational Study
An observational study of Hemodynamic Monitoring, run by Baxter Healthcare Corporation at 1 site 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 regard… 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
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jul 2023to 14 Mar 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 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The population is defined as all patients who meet the study eligibility criteria and have undergone monitoring with the Starling monitor during CRRT. All available data will be included in the analysis.
Who may be able to join
- ≥18 to 95 years of age.
- Patient has undergone hemodynamic monitoring with the Starling monitor during a CRRT treatment.
- Hemodynamic monitoring was completed no earlier than 2018
Who cannot join
- Patients did not have an arterial line in place during CRRT treatment
- Patients on extracorporeal membrane oxygenation (ECMO) or left ventricular assist device (LVAD)
- Patients with end-stage kidney disease on chronic dialysis
- Hemodynamic monitoring with Starling did not occur during CRRT treatment
- Data from Starling, CRRT machine, or arterial line cannot be retrieved
Trial locations and contacts
1 site in 1 country.
United States1 site
Baxter Investigational Site
Lexington, Kentucky, 40506
About this study
Official title: Starling Continuous Renal Replacement Therapy (CRRT) Observational 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 regard 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 during CRRT therapy.
- 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), Thoracic Fluid Content change from preset time period (TFCd), Thoracic Fluid Content from baseline (TFCd0), Changes in SV, CO and other hemodynamic parameters which are derived by Bioreactance® as a result of posture
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. Bioreactance is a measure of 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.
The 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.
This information is used to determine cardiac output. The Starling monitor also measures and displays associated hemodynamic parameters based on calculations of measurements already incorporated into the Starling monitor.
| Study group | Role | What they receive |
|---|---|---|
| Hemodynamic Monitoring | 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 during CRRT treatment. Receives: Device: Starling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in stroke volume (SV) after CRRT initiation
Measured: Day 1 (during CRRT)
Change in cardiac output (CO) after fluid removal
Cardiac physiology adjusted to net ultrafiltration intensities (ml/kg/h)
Measured: Day 1 (during CRRT)
Change in cardiac index (CI) after fluid removal
Cardiac physiology adjusted to net ultrafiltration intensities (ml/kg/h)
Measured: Day 1 (during CRRT)
Change in stroke volume (SV) after fluid removal
Cardiac physiology adjusted to net ultrafiltration intensities (ml/kg/h)
Measured: Day 1 (during CRRT)
Change in stroke volume index (SVI) after fluid removal
Cardiac physiology adjusted to net ultrafiltration intensities (ml/kg/h)
Measured: Day 1 (during CRRT)
Change in Thoracic Fluid Content (TFC) after fluid removal
Cardiac physiology adjusted to net ultrafiltration intensities (ml/kg/h)
Measured: Day 1 (during CRRT)
Change in heart rate (HR) after fluid removal
Cardiac physiology adjusted to net ultrafiltration intensities (ml/kg/h)
Measured: Day 1 (during CRRT)
Change in systolic blood pressure (SBP) after fluid removal
Cardiac physiology adjusted to net ultrafiltration intensities (ml/kg/h)
Measured: Day 1 (during CRRT)
Change in diastolic blood pressure (DBP) after fluid removal
Cardiac physiology adjusted to net ultrafiltration intensities (ml/kg/h)
Measured: Day 1 (during CRRT)
Change in central venous pressure (CVP) after fluid removal
Cardiac physiology adjusted to net ultrafiltration intensities (ml/kg/h)
Measured: Day 1 (during CRRT)
Change in mixed venous oxygen saturation (SVO2) after fluid removal
Perfusion parameter adjusted to net ultrafiltration intensities (ml/kg/h)
Measured: Day 1 (during CRRT)
Change in lactate after fluid removal
Perfusion parameter adjusted to net ultrafiltration intensities (ml/kg/h)
Measured: Day 1 (during CRRT)
Changes in systolic blood pressure (SBP) from beginning to end of CRRT
Measured: Day 1 (Begin CRRT) through Day 1 (End of CRRT)
Changes in diastolic blood pressure (DBP) from beginning to end of CRRT
Measured: Day 1 (Begin CRRT) through Day 1 (End of CRRT)
Changes in mean arterial pressure (MAP) from beginning to end of CRRT
Measured: Day 1 (Begin CRRT) through Day 1 (End of CRRT)
Secondary outcomes (13)
Incidence of intradialytic hypotension (IDH) during CRRT
Measured: Day 1 (during CRRT)
Incidence of intradialytic hypotension (IDH) free time during CRRT
Measured: Day 1 (during CRRT)
Incidence of time to resolution in intradialytic hypotension (IDH) during CRRT
Measured: Day 1 (during CRRT)
Changes in intake and output (I/O) during CRRT
Fluid balance parameter
Measured: Day 1 (during CRRT)
Changes in hourly/daily fluid balance during CRRT
Measured: Day 1 (during CRRT)
Changes in cumulative fluid balance during CRRT
Measured: Day 1 (during CRRT)
Changes in percent fluid overload during CRRT
Fluid balance parameter
Measured: Day 1 (during CRRT)
Changes in ultrafiltration parameters and net ultrafiltration (UFnet) during CRRT
Measured: Day 1 (during CRRT)
Incidence of ultrafiltration failure during CRRT
Including prescribed/archived, time to fluid balance
Measured: Day 1 (during CRRT)
Blood flow rate during CRRT
Measured: Day 1 (during CRRT)
CRRT dose/modality
Measured: Day 1 (during CRRT)
Estimate the contribution degree of certain patient conditions, clinical characteristics, fluid, and CRRT parameters in predicting the IDH risk during CRRT
Measured: Day 1 (during CRRT)
Identify sub-phenotypes of patients at risk of IDH during CRRT
Measured: Day 1 (during CRRT)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2023
- Study start15 Jul 2023 (estimated)
- Primary completion14 Mar 2025 (estimated)
- Study completion14 Mar 2025 (estimated)
Why it stopped: Study Sponsor decided not to move forward with this project.
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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baxter Healthcare Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05729048
- Sponsor's protocol ID
- BXU578332
- Status last verified
- Jul 2023
- First submitted
- 29 Nov 2022
- Last updated
- 14 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Sharing of Clinical Trial Data: Baxter is committed to sharing clinical trial data with external medical experts and scientific researchers in the interest of advancing public health. As such, Baxter will supply anonymized Individual Patient Datasets (IPD) and supporting documents (synopsis of clinical study reports, protocol and SAP's)
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Starling Continuous Renal Replacement Therapy (CRRT) Observational Study
- ClinicalTrials.gov ID
- NCT05729048
- Acronym / sponsor ID
- BXU578332
- 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
- WithdrawnReason stopped: Study Sponsor decided not to move forward with this project.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Baxter Healthcare CorporationIndustry (pharma, biotech, devices)
- Study start
- 15 Jul 2023 (estimated)
- Primary completion
- 14 Mar 2025 (estimated)
- Study completion
- 14 Mar 2025 (estimated)
- First posted
- 15 Feb 2023 (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 regard 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 during CRRT therapy.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hemodynamic Monitoring | – | 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 during CRRT treatment. |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The population is defined as all patients who meet the study eligibility criteria and have undergone monitoring with the Starling monitor during CRRT. All available data will be included in the analysis.
Key inclusion criteria (3 listed)
- ≥18 to 95 years of age.
- Patient has undergone hemodynamic monitoring with the Starling monitor during a CRRT treatment.
- Hemodynamic monitoring was completed no earlier than 2018
Key exclusion criteria (5 listed)
- Patients did not have an arterial line in place during CRRT treatment
- Patients on extracorporeal membrane oxygenation (ECMO) or left ventricular assist device (LVAD)
- Patients with end-stage kidney disease on chronic dialysis
- Hemodynamic monitoring with Starling did not occur during CRRT treatment
- Data from Starling, CRRT machine, or arterial line cannot be retrieved
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. Bioreactance is a measure of 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. The 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. This information is used to determine cardiac output. The Starling monitor also measures and displays associated hemodynamic parameters based on calculations of measurements already incorporated into the Starling monitor. | Device | Hemodynamic Monitoring |
Primary outcome
Change in stroke volume (SV) after CRRT initiation
Time frame: Day 1 (during CRRT)
Change in cardiac output (CO) after fluid removal
Time frame: Day 1 (during CRRT)
Cardiac physiology adjusted to net ultrafiltration intensities (ml/kg/h)
Change in cardiac index (CI) after fluid removal
Time frame: Day 1 (during CRRT)
Cardiac physiology adjusted to net ultrafiltration intensities (ml/kg/h)
Change in stroke volume (SV) after fluid removal
Time frame: Day 1 (during CRRT)
Cardiac physiology adjusted to net ultrafiltration intensities (ml/kg/h)
Change in stroke volume index (SVI) after fluid removal
Time frame: Day 1 (during CRRT)
Cardiac physiology adjusted to net ultrafiltration intensities (ml/kg/h)
Change in Thoracic Fluid Content (TFC) after fluid removal
Time frame: Day 1 (during CRRT)
Cardiac physiology adjusted to net ultrafiltration intensities (ml/kg/h)
Change in heart rate (HR) after fluid removal
Time frame: Day 1 (during CRRT)
Cardiac physiology adjusted to net ultrafiltration intensities (ml/kg/h)
Change in systolic blood pressure (SBP) after fluid removal
Time frame: Day 1 (during CRRT)
Cardiac physiology adjusted to net ultrafiltration intensities (ml/kg/h)
Change in diastolic blood pressure (DBP) after fluid removal
Time frame: Day 1 (during CRRT)
Cardiac physiology adjusted to net ultrafiltration intensities (ml/kg/h)
Change in central venous pressure (CVP) after fluid removal
Time frame: Day 1 (during CRRT)
Cardiac physiology adjusted to net ultrafiltration intensities (ml/kg/h)
Change in mixed venous oxygen saturation (SVO2) after fluid removal
Time frame: Day 1 (during CRRT)
Perfusion parameter adjusted to net ultrafiltration intensities (ml/kg/h)
Change in lactate after fluid removal
Time frame: Day 1 (during CRRT)
Perfusion parameter adjusted to net ultrafiltration intensities (ml/kg/h)
Changes in systolic blood pressure (SBP) from beginning to end of CRRT
Time frame: Day 1 (Begin CRRT) through Day 1 (End of CRRT)
Changes in diastolic blood pressure (DBP) from beginning to end of CRRT
Time frame: Day 1 (Begin CRRT) through Day 1 (End of CRRT)
Changes in mean arterial pressure (MAP) from beginning to end of CRRT
Time frame: Day 1 (Begin CRRT) through Day 1 (End of CRRT)
13 secondary outcomes
Incidence of intradialytic hypotension (IDH) during CRRT
Time frame: Day 1 (during CRRT)
Incidence of intradialytic hypotension (IDH) free time during CRRT
Time frame: Day 1 (during CRRT)
Incidence of time to resolution in intradialytic hypotension (IDH) during CRRT
Time frame: Day 1 (during CRRT)
Changes in intake and output (I/O) during CRRT
Time frame: Day 1 (during CRRT)
Changes in hourly/daily fluid balance during CRRT
Time frame: Day 1 (during CRRT)
Changes in cumulative fluid balance during CRRT
Time frame: Day 1 (during CRRT)
Changes in percent fluid overload during CRRT
Time frame: Day 1 (during CRRT)
Changes in ultrafiltration parameters and net ultrafiltration (UFnet) during CRRT
Time frame: Day 1 (during CRRT)
Incidence of ultrafiltration failure during CRRT
Time frame: Day 1 (during CRRT)
Blood flow rate during CRRT
Time frame: Day 1 (during CRRT)
CRRT dose/modality
Time frame: Day 1 (during CRRT)
Estimate the contribution degree of certain patient conditions, clinical characteristics, fluid, and CRRT parameters in predicting the IDH risk during CRRT
Time frame: Day 1 (during CRRT)
Identify sub-phenotypes of patients at risk of IDH during CRRT
Time frame: Day 1 (during CRRT)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2023.
- Individual participant dataSharing planned: Yes. Sharing of Clinical Trial Data: Baxter is committed to sharing clinical trial data with external medical experts and scientific researchers in the interest of advancing public health. As such, Baxter will supply anonymized Individual Patient Datasets (IPD) and supporting documents (synopsis of clinical study reports, protocol and SAP's)
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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.
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 Hemodynamic Monitoring, run by Baxter Healthcare Corporation 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 3 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: withdrawn, as of the sponsor's last update on 14 Jul 2023. 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 was withdrawn before enrolling participants, so there are no results.
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?
Change in stroke volume (SV) after CRRT initiation (time frame: Day 1 (during CRRT)). The study lists 15 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 14 Jul 2023.