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Completed No phase listed Observational

Comparison of Non-Invasive Methods of Assessing Fluid Responsiveness in ED and ICU Patients

ClinicalTrials.gov ID: NCT02679625

Public ClinicalTrials.gov record NCT02679625. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 6, 2026, 6:40 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

Accurate assessment of fluid responsiveness (FRes) is central to guiding fluid management in septic and critically ill patients. As evidence accumulates that both inadequate and excessive fluid resuscitation are associated with increased morbidity and mortality, it is simultaneously becoming increasingly clear that current widely used methods to predict FRes are of questionable accuracy. The optimal technique to predict FRes would be a non-invasive point-of-care test with not only a high degree of accuracy, but also one which requires minimal training to perform correctly and may be easily performed repeatedly for serial evaluation of FRes during the ongoing management of the critically ill patient. To date, three major ultrasonographic modalities have emerged as viable candidates for the bedside assessment of FRes: 1) measurement of dynamic changes in inferior vena caval diameter (IVC-CI), 2) measurement of dynamic changes in peripheral arterial waveform derived variables (PA Doppler), and 3) echocardiographic measurement of dynamic changes in left ventricular outflow tract waveform derived variables (LVOT Doppler). In this study, the investigators will perform the first direct comparison of techniques representing all three of the above modalities in the prediction of FRes against a non-invasive bioreactance cardiac output monitor (the Cheetah NICOM™), which has been extensively validated against gold-standard invasive methods of cardiac output measurement. The investigators will compare the accuracy of these modalities in both spontaneously breathing and mechanically ventilated patients using passive leg raise testing (PLR) as a surrogate for volume challenge. In addition, the investigators will also elicit information from the treating physician(s) on their clinical assessment of FRes. The investigators will recruit adult patients in the ED and ICU with sepsis, who have received an initial bolus of 20-30 cc/kg of IV fluid, and can tolerate the PLR and US procedures. Prior to US and NICOM measurement, investigators will ask the attending physician managing the patient regarding their assessment of the their fluid status. Then, separate investigators will perform US and NICOM measurements independently to ensure blinding. NICOM data, which has been well validated in septic patients, will be shared with the attending physician. They will then be asked if this new data will change management.

Study identification

NCT ID
NCT02679625
Recruitment status
Completed
Study type
Observational
Phase
Not listed
Enrollment
50 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years to 90 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Oct 31, 2014
Primary completion
Oct 31, 2019
Completion
Nov 30, 2019
Last update posted
Apr 7, 2020

2014 – 2019

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
Olive View-UCLA Sylmar California 91342

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT02679625, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Apr 7, 2020 · Synced Sep 6, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT02679625 live on ClinicalTrials.gov.

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