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

NCT02679625 | Completed

• 1 other identifier: IRB #14H-136004
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Sepsis; Fluid Overload; Hypovolemia

Keywords

Fluid responsiveness, ultrasound

Outcome Measures

Primary Outcomes (1)

• Fluid responsiveness (measured as cardiac output change, velocity time integral change, or maximal velocity change of greater than 10%, with either passive leg raise maneuver or respiratory variability).

  FRes is defined as the ability to predict that subjects who receive a small bolus of 250-500 ml of intravenous fluid will have a rise in their cardiac output or stroke volume of greater than 10%. FRes is a unit-less measurement, as it reflects the percent change in either stroke volume, cardiac index/output, IVC diameter, VTI, or Vmax, as a result of either a passive leg raise or the respiratory cycle. The criterion standard for FRes in this study will be assessed with the NICOM machine. Assessments of FRes using ultrasound-based measures (LVOT, carotid, femoral, and IVC) will be compared to the NICOM-determined assessment of FRes. Analysis is directed at how well the ultrasound-based definitions of FRes perform compared to the NICOM-based assessment.

  Fluid responsiveness is assessed in a three minute interval using the study gold standard, the NICOM. FRes assessment using ultrasound will be performed during this time. One set of measurements will be obtained upon subject admission to the ED or ICU.

Interventions

Ultrasound and NICOM DEVICE

All patients enrolled will have all three ultrasound-based modalities for fluid responsiveness performed, as well as have NICOM data to serve as the comparison standard.

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The investigators will recruit adult patients in the ED and ICU who are septic, have received an initial bolus of 20-30 cc/kg of IV fluid, and there is still a question by the clinical team of whether they are still fluid responsive.

You may qualify if:

• Adult between the age of 18 to 90 years old;
• Not pregnant;
• Not using non-invasive positive pressure ventilation (CPAP or BiPAP);
• No history of heart, lung, and/or liver transplant;
• Not determined by the clinical team to be acutely unstable requiring immediate intervention at the time of data collection, and;
• No contraindications to a passive leg raise test (known or suspected cranio-cerebral or C-spine injury, venous thrombosis, orthopedic injury requiring immobilization or traction, or other contraindications as per clinical team).

You may not qualify if:

• Pregnant;
• Using non-invasive positive pressure ventilation (CPAP or BiPAP);
• Presence of or suspected elevated intracranial pressure;
• Presence of central venous catheters or other medical devices that prevent the use of bedside ultrasound;
• History of heart, lung, and/or liver transplant;
• History of critical aortic stenosis or severe aortic insufficiency;
• Determined by the clinical team to be acutely unstable and requiring immediate intervention at the time of study enrollment or data collection or;
• Has a contraindication to passive leg raise maneuver, e.g. known cervical spinal injury, deep venous thrombosis, orthopedic injury requiring immobilization or traction.

Sponsors & Collaborators

• Olive View-UCLA Education & Research Institute: lead
• University of California, Los Angeles: collaborator

Study Sites (1)

Olive View-UCLA

Sylmar, California, 91342, United States

Location

MeSH Terms

Conditions

Sepsis; Edema; Hypovolemia

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Alan Chiem, MD MPH

  Olive View-UCA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 26, 2014
• First Posted: February 10, 2016
• Study Start: November 1, 2014
• Primary Completion: November 1, 2019
• Study Completion: December 1, 2019
• Last Updated: April 8, 2020

Record last verified: 2020-04

Locations

US (1)