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OpenTrials
Completed

NCT Number: NCT04648293

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.

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Key information

Conditions

Hemodynamic Monitoring

Age range

18 year–95 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Baxter Investigational Site, Denver, Colorado, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 30 day in-hospital mortality rate

    Time frame: Day 1 to Day 30

  2. Number of days on vasopressors

    Time frame: Day 1 to Day 30

  3. Volume of treatment fluid administered

    Time frame: Time of monitoring to completion

  4. Number of participants needing mechanical ventilation

    Time frame: Time of monitoring to completion

  5. Lactate level

    Time frame: Time of monitoring to completion

  6. Number of days in Intensive Care Unit (ICU)

    Time frame: Day 1 to Day 30

  7. Number of days in Hospital

    Time frame: Day 1 to Day 30

Secondary outcomes

  1. Number of participants with COVID-19

    Time frame: Time of monitoring to completion

  2. Number of participants with COVID-19 by treatment type

    Time frame: Time of monitoring to completion

  3. Number of participants with COVID-19 by outcome type

    Time frame: Time of monitoring to completion

  4. Percent of participants that are fluid responsive

    Time frame: Time of monitoring to completion

  5. Number of participants with diastolic dysfunction

    Time frame: Time of monitoring to completion

  6. Percent of participants with fluid responsiveness in diastolic dysfunction

    Time frame: Time of monitoring to completion

  7. Number of participants with device related Non-Serious Adverse Events

    Time frame: Time of monitoring to completion

  8. Number of participants with device related Serious Adverse Events

    Time frame: Time of monitoring to completion

Sponsors and collaborators

Lead sponsor

Baxter Healthcare Corporation

Industry

Registry information

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Dec 1, 2020
Registry last updated
Apr 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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