Evaluating Fluid Responsiveness in ICU Patients Using VTI and Trendelenburg Positioning

This study is looking at a new way to help doctors decide if critically ill patients in the ICU (Intensive Care Unit) need more fluids. Giving too much fluid can be harmful, so it's important to know who will benefit. Researchers are using a method called VTI (Velocity Time Integral), which is a measurement from an echocardiogram (a heart ultrasound), along with Trendelenburg positioning (tilting the patient with their head down). They will compare a patient's VTI measurement when lying flat to when they are in the Trendelenburg position. The goal is to find a specific change in VTI that can accurately predict if a patient will respond well to fluid therapy, helping to prevent complications like fluid overload. This study plans to enroll 400 adult ICU patients who might need fluids due to low blood pressure, fast heart rate, or high lactate levels. The study status is currently unclear.

Study design
This interventional study involves comparing each patient to themselves, with 400 planned participants. Patients will undergo echocardiograms in two different positions.
What's involved
You would have an echocardiogram performed while lying flat and then again while in the Trendelenburg position, for research purposes.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome, change in VTI cutoff, will be measured at approximately 1 year.

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NCT06418022

Evaluating Fluid Responsiveness in ICU Patients Using VTI and Trendelenburg Positioning

UNKNOWN
NAAges 18+InterventionalDiagnostic
Lenox Hill Hospital
~400 participants
Updated 2024-05-16 on ClinicalTrials.gov
What's tested:Trendelenburg positioning VTI

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in VTI cutoff in TP that predicts fluid responsiveness
Measured over ~1 year
Shock
Fluid Overload
Cardiac Output, Low
1 sites across 1 states
New York1
  • Matthew Kheir, MD · PRINCIPAL_INVESTIGATOR · Lenox Hill Hospital- Northwell Health

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Eligibility criteria

Inclusion

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

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 \[LVOT\]).
  • Change in VTI cutoff in TP that predicts fluid responsiveness~1 year

    The objective of this study is to determine the change in VTI cutoff with Trendelenburg positioning that would predict fluid responsiveness in medical and surgical intensive care unit patients.