An observational study in Hemodynamic Monitoring, sponsored by Baxter Healthcare Corporation. Completed at 9 sites in United States. Open to participants aged 18 Years to 95 Years. Per ClinicalTrials.gov, last updated 2024-04-16.
Sponsored by Baxter Healthcare Corporation · Observational
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.
Baxter Healthcare Corporation is the lead sponsor of 78 studies on the registry; 1 is open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 3 (30%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
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.
Device: Starling
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.
Device: Starling
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.
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
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
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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