Clinical trial NCT06418022: Evaluating Fluid Responsiveness in ICU Patients Using VTI and Trendelenburg Positioning
Official title: Evaluating Fluid Responsiveness in Intensive Care Unit Patients Using VTI and Trendelenburg Positioning. TREND-US Trial.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Shock
Fluid Overload
Cardiac Output, Low
Keywords: fluid
responsiveness
VTI
ICU
POCUS
ultrasound
Trendelenburg
Lead sponsor: Lenox Hill Hospital
Sponsor class: OTHER
First posted: 2024-05-16
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is a single-center, minimal risk study that will include a total of 400 critically ill patients, aged 18 and older, that require fluid administration.

In prior studies, fluid responsiveness has been shown after an IV fluid bolus with ≥15% increase in VTI or after a passive leg raise (PLR) with ≥ 15% increase in VTI. Similar to the other maneuvers such as the PLR maneuver, we hope to find an optimal cutoff in the increase in VTI after Trendelenburg positioning based on ROC analysis, with an increase of VTI \>15% in patients after receiving IV fluids as the gold standard. There will be no intervention arm and patients will serve as their own control.
Primary purpose: DIAGNOSTIC

Brief 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.

Detailed description: The investigators will perform an echocardiogram both in the supine and Trendelenburg positions for research purposes prior to the ICU team assessing fluid responsiveness (see paragraph below).

Critically ill patients in which fluid responsiveness is unclear typically admitted to the ICU routinely undergo a bedside echocardiogram in the supine position and then another echocardiogram still in the supine position after receiving IV fluids to assess the patient's fluid responsiveness (i.e., whether giving a small IV fluid bolus increases cardiac output). VTI is an echocardiographic surrogate for cardiac output and is routinely used in the ICU setting in addition to providing additional information on whether a patient is fluid responsive. This method is already standard practice in the medical and surgical ICU in our PCCM department.

Unfortunately, administering IV fluids can potentially cause adverse events such as pulmonary edema, heart failure, interstitial edema, respiratory failure, and death. The use of a method, such as the passive leg raise maneuver (i.e., raising patient's legs by 30 degrees for 1 minute and then evaluating hemodynamic measurements), help predict whether a patient would benefit from IV fluids prior to giving them fluids in order to prevent these aforementioned adverse events since it is a reversible process. Literature and current practice support the use of the passive leg raise (PLR) maneuver in predicting fluid responsiveness, where an increase of at least 15% signifies a positive fluid response. Similar to IV fluids, the PLR maneuver can cause adverse events, is cumbersome, and not feasible in certain circumstances. There is recent research which suggests that Trendelenburg positioning (TP) can be used as an alternative approach that is potentially safer and less cumbersome. This study aims to evaluate a cutoff increase in VTI that would be accurate in predicting fluid responsiveness in patients undergoing TP. As stated above, in our study we will see if placing the patient in TP (i.e., tilt head of the bed 15 degrees downward) will predict if the patient is fluid responsive. The investigators want use ROC analysis to determine the cutoff VTI increase and the accuracy of using TP in predicting fluid responsiveness. The gold standard is to check VTI prior to and after administering an IV fluid bolus and the current literature demonstrates that a VTI increase by 15% is indicative of an appropriate fluid response.

The patients in the study in the ICU will receive IV fluids regardless of our study based on the clinician's discretion (i.e., our study will not affect the decision of the clinician in any way). The bedside echocardiogram takes less than 2 minutes to perform and will not delay care.

Eligibility 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 \[LVOT\]).

Primary outcomes:
measure: Change in VTI cutoff in TP that predicts fluid responsiveness
timeFrame: ~1 year
Secondary outcomes:
measure: Determine if patient factors are independently associated with fluid responsiveness
timeFrame: ~1 year
measure: Association of Trendelenburg positioning on the effect on hemodynamic parameters
timeFrame: ~1 year
measure: Association of Trendelenburg positioning on the effect on hemodynamic parameters
timeFrame: ~1 year
measure: Association of Trendelenburg positioning on the effect on hemodynamic parameters
timeFrame: ~1 year
measure: Association of Trendelenburg positioning on the effect on hemodynamic parameters
timeFrame: ~1 year
measure: Evaluate the predictive accuracy of the change in VTI versus other hemodynamic parameters
timeFrame: ~1 year
Other outcomes:
Locations:
city: New York
country: United States
facility: Lenox Hill Hospital- Northwell Health
state: New York
Study officials:
affiliation: Lenox Hill Hospital- Northwell Health
name: Matthew Kheir, MD
role: PRINCIPAL_INVESTIGATOR
References: