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Evaluating Fluid Responsiveness in ICU Patients Using VTI and Trendelenburg Positioning
Fluid administration is a commonly performed in the ICU for critically ill patients. However, it can lead to complications such as fluid overload, pulmonary edema, and increased mortality in some patients. Therefore, identifying patients who are likely to respond to fluid therapy is crucial for optimizing their management. Several methods have been used to assess fluid responsiveness, such as passive leg raising, stroke volume variation, and cardiac output monitoring. However, these methods have limitations and may not be feasible in all patients. In this study, the investigators aim to evaluate the use of velocity time integral (VTI) and Trendelenburg positioning in predicting fluid responsiveness in ICU patients.
Conditions:
🦠 Shock 🦠 Fluid Overload 🦠 Cardiac Output, Low
🗓️ Study Start (Actual) 1 April 2024
🗓️ Primary Completion (Estimated) 1 April 2025
✅ Study Completion (Estimated) 1 August 2025
👥 Enrollment (Estimated) 400
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 New York, New York, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * Adult patients (≥ 18 years old) admitted to the medical or surgical ICU.
    • * Patients who require fluid administration for suspicion of hypovolemia or indicated for volume expansion due to any one of the following: hypotension (systolic blood pressure \< 90 mm Hg or mean arterial pressure \< 65 mm Hg), tachycardia (heart rate \> 100 beats per min), blood lactate \> 2.0 mmol/L, skin mottling, oliguria (urine output \< 30 ml/hr), or requiring vasopressor/inotrope support.
    • * Patients who are able to tolerate the Trendelenburg position.

    Exclusion Criteria:

    • * Pregnancy.
    • * Prisoners and institutionalized patients.
    • * Patients who are not able to tolerate the Trendelenburg position. This includes patients with increased intra-cranial hypertension, intra-abdominal hypertension and gastric retention which places a risk for stomach fluid aspiration.
    • * Unsatisfactory cardiac echogenicity (an inability to correctly align the Doppler beam to generate reliable VTI measurements at the left ventricular outflow tract \[LVOT\]).
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 6 May 2024
  • First Submitted that Met QC Criteria 13 May 2024
  • First Posted 16 May 2024

Study Record Updates

  • Last Update Submitted that Met QC Criteria 13 May 2024
  • Last Update Posted 16 May 2024
  • Last Verified May 2024
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