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Clinical trialNCT02679625CompletedObservational

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

SponsorOlive View-UCLA Education & Research InstituteEnrollment50Fluid OverloadHypovolemiaSepsis
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

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Sites

1 registered facility, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States
  • Olive View-Ucla

    Sylmar, California, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

No drug or biological interventions are in our data for this study. It may test a procedure, device or behavioral intervention, or the intervention list isn't in our current snapshot. See the registry record ↗. Why? →

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
1 Nov 2014
Primary completion
1 Nov 2019
Completion
1 Dec 2019
Last update posted
8 Apr 2020
Registered enrollment
50
Registry id
NCT02679625

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 11 Nov 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.