Evaluating Fluid Responsiveness in ICU Patients Using VTI and Trendelenburg Positioning (TREND-US)

Evaluating Fluid Responsiveness in Intensive Care Unit Patients Using VTI and Trendelenburg Positioning. TREND-US Trial.

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.

Study Overview

• Status: Recruiting
• Conditions: Shock; Fluid Overload; Cardiac Output, Low
• Intervention / Treatment: Device: Trendelenburg positioning VTI

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.

• Study Type: Interventional
• Enrollment (Estimated): 400
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Matthew Kheir, MD; Phone Number: 516-465-1910; Email: mkheir1@northwell.edu
• Study Contact Backup: Name: Sara Velichkovikj, BS; Phone Number: 212-434-4087

Study Locations

• United States
  • New York
    • New York, New York, United States, 10075
      • Recruiting
      • Lenox Hill Hospital- Northwell Health
      • Contact: Matthew Kheir, MD; Phone Number: 212-434-4087; Email: mkheir1@northwell.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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]).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Fluid challenge (control); 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.

Device: Trendelenburg positioning VTI; There are essentially two arms, whereby the patients is being compared to themselves. The "intervention arm" is the same patient undergoing TP from the baseline supine position to determine the change in VTI after subjecting to TP. We will be using a Sonosite PX ultrasound system, which is intended for diagnostic ultrasound imaging or fluid flow analysis of the human body and, more specifically, for our echocardiographic measurements of velocity time integral (VTI; surrogate for stroke volume and cardiac output). The Sonosite PX is a general-purpose ultrasound system intended for use by qualified physicians and healthcare professionals, for evaluation by ultrasound imaging or fluid flow analysis of the human body. This is an FDA-cleared (510K# K200964) commercial device legally marketed in the United States that is being used in accordance with labeling.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in VTI cutoff in TP that predicts fluid responsiveness	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.	~1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Determine if patient factors are independently associated with fluid responsiveness	Evaluate other patient factors (e.g., demographics) to determine if they are independently associated with fluid responsiveness.	~1 year
Association of Trendelenburg positioning on the effect on hemodynamic parameters	Evaluate the effect of Trendelenburg positioning (TP) and fluid challenge (FC) on hemodynamic parameter of blood pressure (i.e., if there is a statistically significant change in the hemodynamic parameter after TP or FC).	~1 year
Association of Trendelenburg positioning on the effect on hemodynamic parameters	Evaluate the effect of Trendelenburg positioning (TP) and fluid challenge (FC) on hemodynamic parameter of heart rate (i.e., if there is a statistically significant change in the hemodynamic parameter after TP or FC).	~1 year
Association of Trendelenburg positioning on the effect on hemodynamic parameters	Evaluate the effect of Trendelenburg positioning (TP) and fluid challenge (FC) on hemodynamic parameter of pulse pressure (i.e., if there is a statistically significant change in the hemodynamic parameter after TP or FC).	~1 year
Association of Trendelenburg positioning on the effect on hemodynamic parameters	Evaluate the effect of Trendelenburg positioning (TP) and fluid challenge (FC) on hemodynamic parameter of central venous pressure (i.e., if there is a statistically significant change in the hemodynamic parameter after TP or FC).	~1 year
Evaluate the predictive accuracy of the change in VTI versus other hemodynamic parameters	Use receiver operating characteristic (ROC) curves to compare the predictive accuracy of the change in VTI compared to the change of certain hemodynamic parameters (e.g., pulse pressure, systolic blood pressure, diastolic blood pressure) with Trendelenburg positioning.	~1 year

Collaborators and Investigators

• Sponsor: Lenox Hill Hospital
• Investigators: Principal Investigator: Matthew Kheir, MD, Lenox Hill Hospital- Northwell Health

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2024
• Primary Completion (Estimated): April 1, 2025
• Study Completion (Estimated): August 1, 2025

Study Registration Dates

• First Submitted: May 6, 2024
• First Submitted That Met QC Criteria: May 13, 2024
• First Posted (Actual): May 16, 2024

Study Record Updates

• Last Update Posted (Actual): May 16, 2024
• Last Update Submitted That Met QC Criteria: May 13, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: ultrasound; ICU; fluid; Trendelenburg; responsiveness; POCUS; VTI
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Cardiac Output, Low
• Other Study ID Numbers: 23-0441

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes