Evaluating fluid responsiveness in ICU patients using echocardiography and positioning techniques
Evaluating Fluid Responsiveness in Intensive Care Unit Patients Using VTI and Trendelenburg Positioning. TREND-US Trial.
This study is testing whether using echocardiograms and a special positioning technique can help doctors figure out which critically ill ICU patients will benefit from receiving extra fluids.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 400 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Lenox Hill Hospital Academic / other |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT06418022 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the effectiveness of using velocity time integral (VTI) and Trendelenburg positioning to predict fluid responsiveness in critically ill patients in the ICU. Patients will undergo echocardiograms in both supine and Trendelenburg positions to evaluate their response to fluid administration. The goal is to optimize fluid management and minimize complications associated with fluid overload. By identifying patients who are likely to benefit from fluid therapy, the study seeks to improve patient outcomes in the ICU setting.
Who should consider this trial
Good fit: Ideal candidates include adult ICU patients requiring fluid administration due to suspected hypovolemia or other indicators of low cardiac output.
Not a fit: Patients who cannot tolerate the Trendelenburg position or have conditions that contraindicate fluid administration may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to better fluid management in ICU patients, reducing the risk of complications and improving survival rates.
How similar studies have performed: Previous studies have shown promise in using echocardiographic methods to assess fluid responsiveness, but this specific approach combining VTI and Trendelenburg positioning is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 \[LVOT\]).
Where this trial is running
New York, New York
- Lenox Hill Hospital- Northwell Health — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: Matthew Kheir, MD — Lenox Hill Hospital- Northwell Health
- Study coordinator: Matthew Kheir, MD
- Email: mkheir1@northwell.edu
- Phone: 516-465-1910
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.