NCT02972827

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: Santa Barbara Cottage Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Severe Sepsis
• Septic Shock

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2015-05-01
• Primary completion: 2018-06-01
• Completion: 2022-05-01
• First posted: 2016-11-23
• Last updated: 2021-07-02

Locations

1 site across 1 country: United States