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Trendelenburg Positioning for Fluid Responsiveness in ICU Patients (TREND-US Trial)

N/A

Recruiting

Led By Matthew Kheir, MD

Research Sponsored by Lenox Hill Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Adult patients (≥ 18 years old) admitted to the medical or surgical ICU

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up ~1 year

Awards & highlights

No Placebo-Only Group

Summary

"This trial aims to find a better way to determine if ICU patients will benefit from receiving fluids, as giving fluids can sometimes cause harmful effects. The study will look at using velocity time integral (VTI

Who is the study for?

This trial is for ICU patients who are critically ill with conditions like shock, fluid overload, or low cardiac output. It's designed to find out if they'll respond well to fluid therapy without the risk of complications.

What is being tested?

The study tests whether using VTI (a way to measure blood flow) and Trendelenburg positioning (lying on your back with feet higher than head) can predict how well ICU patients will respond to fluids given for their condition.

What are the potential side effects?

Since this trial involves assessment methods rather than medications, traditional side effects aren't a concern. However, there may be discomfort or risks associated with the Trendelenburg position such as increased pressure in the chest.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18 years or older and admitted to the ICU.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ ~1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and ~1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in VTI cutoff in TP that predicts fluid responsiveness

Secondary study objectives

Association of Trendelenburg positioning on the effect on hemodynamic parameters

Determine if patient factors are independently associated with fluid responsiveness

Evaluate the predictive accuracy of the change in VTI versus other hemodynamic parameters

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Fluid challenge (control)Experimental Treatment1 Intervention

This study is evaluating the potential of Trendelenburg positioning (TP) in determining fluid responsiveness by using the change in velocity time integral (VTI), and echocardiographic parameter that can be used as a surrogate for stroke volume and cardiac output. There are essentially two arms, whereby the patients is being compared to themselves. The "control arm" is the patient receiving a fluid challenge (FC; IV fluid bolus of 500cc crystalloids- either 0.9% Normal Saline or Lactated Ringer's solution) that the clinician would have given regardless of the study; the change of VTI is collected after administration of IV fluids with comparison to the baseline supine position. The "intervention arm" is the same patient undergoing TP from the baseline supine position to determine the change in VTI after subjecting to TP.

0 / 1Eligibility criteria met