Evaluating Fluid Responsiveness in ICU Patients Using VTI and Trendelenburg Positioning

NCT06418022 | Recruiting DMC FDA Device

• 1 other identifier: 23-0441
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Shock; Fluid Overload; Cardiac Output, Low

Keywords

fluid; responsiveness; VTI; ICU; POCUS; ultrasound; Trendelenburg

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Determine if patient factors are independently associated with fluid responsiveness

  ~1 year

• Association of Trendelenburg positioning on the effect on hemodynamic parameters

  ~1 year

• Association of Trendelenburg positioning on the effect on hemodynamic parameters

  ~1 year

• Association of Trendelenburg positioning on the effect on hemodynamic parameters

  ~1 year

• Association of Trendelenburg positioning on the effect on hemodynamic parameters

  ~1 year

Study Arms (1)

Fluid challenge (control)

OTHER

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

Interventions

Trendelenburg positioning VTI DEVICE

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.

Fluid challenge (control)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 \[LVOT\]).

Sponsors & Collaborators

• Lenox Hill Hospital: lead

Study Sites (1)

Lenox Hill Hospital- Northwell Health

New York, New York, 10075, United States

RECRUITING

MeSH Terms

Conditions

Shock; Edema; Cardiac Output, Low

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Heart Diseases; Cardiovascular Diseases

Study Officials

• Matthew Kheir, MD

  Lenox Hill Hospital- Northwell Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Matthew Kheir, MD

CONTACT

516-465-1910; mkheir1@northwell.edu

Sara Velichkovikj, BS

CONTACT

212-434-4087

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: May 6, 2024
• First Posted: May 16, 2024
• Study Start: April 1, 2024
• Primary Completion: April 1, 2025
• Study Completion: August 1, 2025
• Last Updated: May 16, 2024

Record last verified: 2024-05

Locations

US (1)