Recruiting

Fluid Responsiveness

Sponsor:

Lenox Hill Hospital

Code:

NCT06418022

Conditions

Shock

Fluid Overload

Cardiac Output, Low

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Trendelenburg positioning VTI

Study Details

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

Study ID

NCT06418022

Start date

Apr 1, 2024

Status verified date

May, 2024

Completion date

Aug 1, 2025

Anticipated

Primary completion date

Apr 1, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

400 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

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.

Interventions

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.

Primary outcome measure

  • Change in VTI cutoff in TP that predicts fluid responsiveness [ Time Frame: ~1 year ]

Central Contacts and Locations

Central contacts

Matthew Kheir, MD

516-465-1910mkheir1@northwell.edu

Sara Velichkovikj, BS

212-434-4087

Locations

Lenox Hill Hospital- Northwell Health

Recruiting

New York, New York, United States, 10075

Contacts

Matthew Kheir, MD

212-434-4087mkheir1@northwell.edu

More Information

Sponsor

Lenox Hill Hospital

Last update posted

May 16, 2024

Last verified

May, 2024

Keywords

  • fluid
  • responsiveness
  • VTI
  • ICU
  • POCUS
  • ultrasound
  • Trendelenburg

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Lenox Hill Hospital on 2024-05-16.