Evaluating Fluid Responsiveness in ICU Patients Using VTI and Trendelenburg Positioning (NCT06418022) | Clinical Trial Compass
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Evaluating Fluid Responsiveness in ICU Patients Using VTI and Trendelenburg Positioning
United States400 participantsStarted 2024-04-01
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 \[LVOT\]).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in VTI cutoff in TP that predicts fluid responsiveness