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

Septic Shock Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02972827
• Other study ID #: 15-21
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 2015
• Est. completion date: May 2022

Study information

• Verified date: June 2021
• Source: Santa Barbara Cottage Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 38
• Est. completion date: May 2022
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Sepsis
• Septic Shock
• Severe Sepsis
• Shock
• Shock, Septic
• Toxemia

Intervention

Device:
• NICOM/FloTrac
Use of noninvasive cardiac output and minimally invasive cardiac output monitors

Other:
• Crystalloid Fluid Challenge
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.

Locations

Country	Name	City	State
United States	Santa Barbara Cottage Hospital	Santa Barbara	California

Sponsors (1)

Lead Sponsor	Collaborator
Santa Barbara Cottage Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Decrease in vasopressor dose, in response to fluid therapy guided by passive leg raise response using NICOM or Flotrac devices		48 hours