Starling Registry Study

NCT04648293 | Completed FDA Device

• 1 other identifier: BXU553561
• Study Type: observational
• Target: 1,207
• Locations: 1 country
• Sites: 9

Brief 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 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

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)

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (8)

• 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

Study Arms (2)

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

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

Interventions

Starling DEVICE

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.

Improvement in Hemodynamics; No Improvement in Hemodynamics

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• None

Sponsors & Collaborators

• Baxter Healthcare Corporation: lead

Study Sites (9)

Baxter Investigational Site

Denver, Colorado, 80204, United States

Location

Baxter Investigational Site

Quincy, Illinois, 62301, United States

Location

Baxter Investigational Site

Kansas City, Kansas, 66160, United States

Location

Baxter Investigational Site

St Louis, Missouri, 63110, United States

Location

Mercy Hospital St. Louis

St Louis, Missouri, 63141, United States

Location

Baxter Investigational Site

Camden, New Jersey, 08103, United States

Location

Baxter Investigational Site

Cleveland, Ohio, 44195-0001, United States

Location

Baxter Investigational Site

Columbus, Ohio, 43210, United States

Location

Baxter Investigational SIte

Galveston, Texas, 77555, United States

Location

Study Officials

• Caio Plopper, MD

  Baxter Healthcare

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 30 Days
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 23, 2020
• First Posted: December 1, 2020
• Study Start: November 16, 2020
• Primary Completion: February 21, 2024
• Study Completion: February 21, 2024
• Last Updated: April 16, 2024

Record last verified: 2024-04

Locations

US (9)