Starling Registry Study
- Conditions
- Hemodynamic Monitoring
- Interventions
- Device: Starling
- Registration Number
- NCT04648293
- Lead Sponsor
- Baxter Healthcare Corporation
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1207
- ≥18 to 95 years of age
- Patient has undergone hemodynamic monitoring with the Starling monitor
- Hemodynamic monitoring was completed no earlier than 2018
- None
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description No Improvement in Hemodynamics 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. Improvement in Hemodynamics 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. 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.
- Primary Outcome Measures
Name Time Method 30 day in-hospital mortality rate Day 1 to Day 30 Number of days in Hospital Day 1 to Day 30 Volume of treatment fluid administered Time of monitoring to completion Number of days on vasopressors Day 1 to Day 30 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
- Secondary Outcome Measures
Name Time Method Number of participants with device related Serious Adverse Events Time of monitoring to completion Percent of participants that are fluid responsive Time of monitoring to completion Number of participants with COVID-19 Time of monitoring to completion Percent of participants with fluid responsiveness in diastolic dysfunction 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 Number of participants with diastolic dysfunction Time of monitoring to completion Number of participants with device related Non-Serious Adverse Events Time of monitoring to completion
Trial Locations
- Locations (3)
Baxter Investigational Site
🇺🇸Columbus, Ohio, United States
Mercy Hospital St. Louis
🇺🇸Saint Louis, Missouri, United States
Baxter Investigational SIte
🇺🇸Galveston, Texas, United States