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NCT02679625 · ClinicalTrials.gov registry record

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

A clinical trial of Sepsis and Fluid Overload, sponsored by Olive View-UCLA Education & Research Institute.

Completed
Registry status
50
Enrollment target
1
Study location

NCT02679625 is a study of Sepsis and Fluid Overload that has completed, run by Olive View-UCLA Education & Research Institute. The registered enrollment target is 50 participants, below the 6,564-participant average among 90 other Sepsis trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT02679625, a study of Sepsis and Fluid Overload, has completed, sponsored by Olive View-UCLA Education & Research Institute.

COMPLETED
Registry status
50 participants
Enrollment target
1
Study location

Study Summary

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 proce

Interventions

  • DEVICE Ultrasound and NICOM

Study Locations (1)

California

  • Olive View-UCLA - Sylmar

Trial Details

FieldValue
Enrollment Target 50 participants
Start Date 2014-11-01
Est. Completion 2019-12-01

What the Registry Record Tells You About NCT02679625

The ClinicalTrials.gov registry entry for NCT02679625 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 6,564-participant average among 90 other Sepsis trials with a reported enrollment target (99% lower). The listed sponsor is Olive View-UCLA Education & Research Institute, which has 11 total studies on file at ClinicalTrials.gov.

The record links to 3 conditions, with Sepsis appearing as the primary indexed condition, and to 1 intervention - of which Ultrasound and NICOM is the first listed.

NCT02679625 reports 1 study location spanning 1 distinct geographic area - top geographies include California.

Frequently Asked Questions

What is clinical trial NCT02679625 about?

NCT02679625 is a clinical study titled "Comparison of Non-Invasive Methods of Assessing Fluid Responsiveness in ED and ICU Patients". 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 increas...

What is the current status of trial NCT02679625?

This trial is currently completed. The enrollment target is 50 participants. The study started on 2014-11-01. Estimated completion is 2019-12-01.

What conditions does trial NCT02679625 study?

This clinical trial studies the following conditions: Sepsis, Fluid Overload, Hypovolemia.

What interventions are being tested in trial NCT02679625?

The interventions under investigation include: Ultrasound and NICOM (DEVICE).

Who is sponsoring clinical trial NCT02679625?

This trial is sponsored by Olive View-UCLA Education & Research Institute, which has 11 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02679625 being conducted?

This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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