Monitoring Devices in Prediction of Fluid Responsiveness in Severe Sepsis and Septic Shock

Study Overview
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Brief Summary
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Comparison of noninvasive cardiac output monitor (NICOM, Cheetah Medical) with Edwards FloTrac minimally-invasive cardiac output monitor in predicting fluid responsiveness in sepsis and septic shock.

Detailed Description
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Study will evaluate ability of passive leg raise test to predict fluid responsiveness in patients in septic shock, on vasopressors, using both the NICOM and FloTrac devices. An increase in CI, SVI, or Pulse Pressure of >10% in response to the passive leg raise will be considered a positive passive leg raise test, and the same indicators will be considered a significant response to a fluid challenge with either crystalloids or colloids.Each device will be evaluated independently, but simultaneously.

Official Title
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Comparison of the Accuracy of Monitoring Devices in Prediction of Fluid Responsiveness in Severe Sepsis and Septic Shock

Conditions
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Severe Sepsis, Septic Shock

Intervention / Treatment
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* Device: NICOM/FloTrac
* Other: Crystalloid Fluid Challenge


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All adult patients with severe sepsis or septic shock, who have arterial catheter placed with FloTrac monitor, with or without a central venous catheter. Exclusion Criteria: Declination of consent Known allergy to adhesive Pregnancy Contraindication to raising legs or head to 45 degrees for 3 minute intervals

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NICOM/FloTrac<br>500-1000ml Crystalloid fluid challenge (normal saline or plasmalyte) to be given for positive passive leg raise test by either device, and also will be given at baseline, regardless of baseline PLR response. | Device: NICOM/FloTrac<br>* Use of noninvasive cardiac output and minimally invasive cardiac output monitors<br>Other: Crystalloid Fluid Challenge<br>* 500-1000ml Normal Saline or Plasmalyte intravenous fluid bolus will be given at baseline, and following a positive passive leg raise response as defined by a 10% or greater increase in any of: stroke volume index, cardiac index, or pulse pressure, as measured by the NICOM or FloTrac Monitors.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants who have agreement or disagreement between passive leg raise response and subsequent intravenous fluid challenge | Positive passive leg raise response is defined as a 10% or greater increase in any of: stroke volume index, cardiac index, or pulse pressure following passive leg raise of 45 degrees for 3 minutes. Positive response to fluid challenge is defined as a 10% or greater increase in any of the same parameters following a 500ml or 1000 ml fluid challenge given over 10-15 minutes, using the same instrument, (NICOM or FloTrac). A negative response would be < 10% increase in these parameters using the same instrument | 15 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decrease in vasopressor dose, in response to fluid therapy guided by passive leg raise response using NICOM or Flotrac devices |  | 48 hours |