Starling Registry Study

Hemodynamic Monitoring Clinical Trial

Official title:

Starling Registry Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04648293
• Other study ID #: BXU553561
• Status: Completed
• Start date: November 16, 2020
• Est. completion date: February 21, 2024

Study information

• Verified date: April 2024
• Source: Baxter Healthcare Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1207
• Est. completion date: February 21, 2024
• Est. primary completion date: February 21, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 95 Years

Eligibility

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

Related Conditions & MeSH terms

• Hemodynamic Monitoring

Intervention

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.

Locations

Country	Name	City	State
United States	Baxter Investigational Site	Camden	New Jersey
United States	Baxter Investigational Site	Cleveland	Ohio
United States	Baxter Investigational Site	Columbus	Ohio
United States	Baxter Investigational Site	Denver	Colorado
United States	Baxter Investigational SIte	Galveston	Texas
United States	Baxter Investigational Site	Kansas City	Kansas
United States	Baxter Investigational Site	Quincy	Illinois
United States	Baxter Investigational Site	Saint Louis	Missouri
United States	Mercy Hospital St. Louis	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Baxter Healthcare Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	30 day in-hospital mortality rate		Day 1 to Day 30
Primary	Number of days on vasopressors		Day 1 to Day 30
Primary	Volume of treatment fluid administered		Time of monitoring to completion
Primary	Number of participants needing mechanical ventilation		Time of monitoring to completion
Primary	Lactate level		Time of monitoring to completion
Primary	Number of days in Intensive Care Unit (ICU)		Day 1 to Day 30
Primary	Number of days in Hospital		Day 1 to Day 30
Secondary	Number of participants with COVID-19		Time of monitoring to completion
Secondary	Number of participants with COVID-19 by treatment type		Time of monitoring to completion
Secondary	Number of participants with COVID-19 by outcome type		Time of monitoring to completion
Secondary	Percent of participants that are fluid responsive		Time of monitoring to completion
Secondary	Number of participants with diastolic dysfunction		Time of monitoring to completion
Secondary	Percent of participants with fluid responsiveness in diastolic dysfunction		Time of monitoring to completion
Secondary	Number of participants with device related Non-Serious Adverse Events		Time of monitoring to completion
Secondary	Number of participants with device related Serious Adverse Events		Time of monitoring to completion