Clinical trial NCT04648293: Starling Registry Study
Official title: Starling Registry Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
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)
Lead sponsor: Baxter Healthcare Corporation
Sponsor class: INDUSTRY
First posted: 2020-12-01
Enrollment: 1207
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: 30 day in-hospital mortality rate
timeFrame: Day 1 to Day 30
measure: Number of days on vasopressors
timeFrame: Day 1 to Day 30
measure: Volume of treatment fluid administered
timeFrame: Time of monitoring to completion
measure: Number of participants needing mechanical ventilation
timeFrame: Time of monitoring to completion
measure: Lactate level
timeFrame: Time of monitoring to completion
measure: Number of days in Intensive Care Unit (ICU)
timeFrame: Day 1 to Day 30
measure: Number of days in Hospital
timeFrame: Day 1 to Day 30
Secondary outcomes:
measure: Number of participants with COVID-19
timeFrame: Time of monitoring to completion
measure: Number of participants with COVID-19 by treatment type
timeFrame: Time of monitoring to completion
measure: Number of participants with COVID-19 by outcome type
timeFrame: Time of monitoring to completion
measure: Percent of participants that are fluid responsive
timeFrame: Time of monitoring to completion
measure: Number of participants with diastolic dysfunction
timeFrame: Time of monitoring to completion
measure: Percent of participants with fluid responsiveness in diastolic dysfunction
timeFrame: Time of monitoring to completion
measure: Number of participants with device related Non-Serious Adverse Events
timeFrame: Time of monitoring to completion
measure: Number of participants with device related Serious Adverse Events
timeFrame: Time of monitoring to completion
Other outcomes:
Locations:
city: Denver
country: United States
facility: Baxter Investigational Site
state: Colorado
city: Quincy
country: United States
facility: Baxter Investigational Site
state: Illinois
city: Kansas City
country: United States
facility: Baxter Investigational Site
state: Kansas
city: Saint Louis
country: United States
facility: Baxter Investigational Site
state: Missouri
city: Saint Louis
country: United States
facility: Mercy Hospital St. Louis
state: Missouri
city: Camden
country: United States
facility: Baxter Investigational Site
state: New Jersey
city: Cleveland
country: United States
facility: Baxter Investigational Site
state: Ohio
city: Columbus
country: United States
facility: Baxter Investigational Site
state: Ohio
city: Galveston
country: United States
facility: Baxter Investigational SIte
state: Texas
Study officials:
affiliation: Baxter Healthcare
name: Caio Plopper, MD
role: STUDY_DIRECTOR
References: