Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT06418022 |
| Other study ID # |
23-0441 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
April 1, 2024 |
| Est. completion date |
August 1, 2025 |
Study information
| Verified date |
May 2024 |
| Source |
Lenox Hill Hospital |
| Contact |
Matthew Kheir, MD |
| Phone |
516-465-1910 |
| Email |
mkheir1[@]northwell.edu |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
