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

Not Applicable

• Conditions: Severe Sepsis; Septic Shock
• Interventions: Device: NICOM/FloTrac; Other: Crystalloid Fluid Challenge

• Registration Number: NCT02972827
• Lead Sponsor: Santa Barbara Cottage Hospital

Brief Summary

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

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.

Study Timeline

• Study Start: 2015-05
• Study First Submitted: 2016-10-30
• Study First Submitted QC: 2016-11-21
• Study First Posted: 2016-11-23
• Primary Completion: 2018-06
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-30
• Last Update Posted: 2021-07-02
• Study Completion: 2022-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 38

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
NICOM/FloTrac	NICOM/FloTrac	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.
NICOM/FloTrac	Crystalloid Fluid Challenge	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.

Primary Outcome Measures

Name	Time	Method
Number of participants who have agreement or disagreement between passive leg raise response and subsequent intravenous fluid challenge	15 minutes	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

Secondary Outcome Measures

Name	Time	Method
Decrease in vasopressor dose, in response to fluid therapy guided by passive leg raise response using NICOM or Flotrac devices	48 hours

Trial Locations

Locations (1)

Santa Barbara Cottage Hospital; 🇺🇸 Santa Barbara, California, United States