ShockTREND-USNCT06418022
Evaluating Fluid Responsiveness in ICU Patients Using VTI and Trendelenburg Positioning
A study testing Trendelenburg positioning VTI in people with Shock and Fluid Overload, run by Northwell Health at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Shock, Fluid Overload, Cardiac Output, Low
- What is being tested?
- Trendelenburg positioning VTI
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2024to 6 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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]).
Trial locations and contacts
1 site in 1 country.
United States1 site
Lenox Hill Hospital- Northwell Health
New York, New York, 10075
About this study
Official title: 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.
Read the 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.
- Conditions
- Shock, Fluid Overload, Cardiac Output, Low
- Being tested
- Trendelenburg positioning VTI
- Keywords
- fluid, responsiveness, VTI, ICU, POCUS, ultrasound, Trendelenburg
- Medical subject headings
- Shock, Edema, Cardiac Output, Low
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trendelenburg positioning VTIDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Trendelenburg positioning VTI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: ~1 year
Secondary outcomes (6)
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.
Measured: ~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).
Measured: ~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).
Measured: ~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).
Measured: ~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).
Measured: ~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.
Measured: ~1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2024
- Study start1 Apr 2024
- Primary completion6 Mar 2025
- Study completion6 Mar 2025
Why it stopped: NO PATIENTS ENTERED
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ShockStudies of the same condition, open and under way.
- More trials run by Northwell HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Margarita Oks, Lenox Hill Hospital
- Investigators
- Matthew Kheir, MD, Principal investigator, Lenox Hill Hospital- Northwell Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06418022
- Sponsor's protocol ID
- 23-0441
- Acronym
- TREND-US
- Status last verified
- Oct 2026
- First submitted
- 6 May 2024
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Fluid Responsiveness in Intensive Care Unit Patients Using VTI and Trendelenburg Positioning. TREND-US Trial.
- ClinicalTrials.gov ID
- NCT06418022
- Acronym / sponsor ID
- TREND-US / 23-0441
- Conditions
- Shock, Fluid Overload, Cardiac Output, Low
- Keywords
- fluid, responsiveness, VTI, ICU, POCUS, ultrasound, Trendelenburg
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: NO PATIENTS ENTERED
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 6 Mar 2025 (actual)
- Study completion
- 6 Mar 2025 (actual)
- First posted
- 16 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Fluid challenge (control) | Other | Device: Trendelenburg positioning VTIThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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]).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trendelenburg positioning VTIThere 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. | Device | Fluid challenge (control) |
Primary outcome
Change in VTI cutoff in TP that predicts fluid responsiveness
Time frame: ~1 year
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.
6 secondary outcomes
Determine if patient factors are independently associated with fluid responsiveness
Time frame: ~1 year
Association of Trendelenburg positioning on the effect on hemodynamic parameters
Time frame: ~1 year
Association of Trendelenburg positioning on the effect on hemodynamic parameters
Time frame: ~1 year
Association of Trendelenburg positioning on the effect on hemodynamic parameters
Time frame: ~1 year
Association of Trendelenburg positioning on the effect on hemodynamic parameters
Time frame: ~1 year
Evaluate the predictive accuracy of the change in VTI versus other hemodynamic parameters
Time frame: ~1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthew Kheir, MD principal investigator
Lenox Hill Hospital- Northwell Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trendelenburg positioning VTI in people with Shock and Fluid Overload, run by Northwell Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in VTI cutoff in TP that predicts fluid responsiveness (time frame: ~1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.