Starling Registry 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.

Study Overview

• Status: Completed
• Conditions: Hemodynamic Monitoring
• Intervention / Treatment: Device: Starling

• Study Type: Observational
• Enrollment (Actual): 1207

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Denver, Colorado, United States, 80204
      • Baxter Investigational Site
  • Illinois
    • Quincy, Illinois, United States, 62301
      • Baxter Investigational Site
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • Baxter Investigational Site
  • Missouri
    • Saint Louis, Missouri, United States, 63141
      • Mercy Hospital St. Louis
    • Saint Louis, Missouri, United States, 63110
      • Baxter Investigational Site
  • New Jersey
    • Camden, New Jersey, United States, 08103
      • Baxter Investigational Site
  • Ohio
    • Cleveland, Ohio, United States, 44195-0001
      • Baxter Investigational Site
    • Columbus, Ohio, United States, 43210
      • Baxter Investigational Site
  • Texas
    • Galveston, Texas, United States, 77555
      • Baxter Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 95 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

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.

Description

Inclusion Criteria:

• ≥18 to 95 years of age
• Patient has undergone hemodynamic monitoring with the Starling monitor
• Hemodynamic monitoring was completed no earlier than 2018

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	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.
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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
30 day in-hospital mortality rate	Day 1 to Day 30
Number of days on vasopressors	Day 1 to Day 30
Volume of treatment fluid administered	Time of monitoring to completion
Number of participants needing mechanical ventilation	Time of monitoring to completion
Lactate level	Time of monitoring to completion
Number of days in Intensive Care Unit (ICU)	Day 1 to Day 30
Number of days in Hospital	Day 1 to Day 30

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of participants with COVID-19	Time of monitoring to completion
Number of participants with COVID-19 by treatment type	Time of monitoring to completion
Number of participants with COVID-19 by outcome type	Time of monitoring to completion
Percent of participants that are fluid responsive	Time of monitoring to completion
Number of participants with diastolic dysfunction	Time of monitoring to completion
Percent of participants with fluid responsiveness in diastolic dysfunction	Time of monitoring to completion
Number of participants with device related Non-Serious Adverse Events	Time of monitoring to completion
Number of participants with device related Serious Adverse Events	Time of monitoring to completion

Collaborators and Investigators

• Sponsor: Baxter Healthcare Corporation
• Investigators: Study Director: Caio Plopper, MD, Baxter Healthcare

Study record dates

Study Major Dates

• Study Start (Actual): November 16, 2020
• Primary Completion (Actual): February 21, 2024
• Study Completion (Actual): February 21, 2024

Study Registration Dates

• First Submitted: November 23, 2020
• First Submitted That Met QC Criteria: November 30, 2020
• First Posted (Actual): December 1, 2020

Study Record Updates

• Last Update Posted (Actual): April 16, 2024
• Last Update Submitted That Met QC Criteria: April 13, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• 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)
• Other Study ID Numbers: BXU553561

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No