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

Santa Barbara Cottage Hospital

Status: Unknown

Conditions: Severe Sepsis; Septic Shock

Treatments: Other: Crystalloid Fluid Challenge; Device: NICOM/FloTrac

Study type: Interventional

Funder types: Other

Identifiers

NCT02972827

15-21

Details and patient eligibility

About

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.

Full 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.

Enrollment: 38 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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38 participants in 1 patient group

NICOM/FloTrac

Experimental group

Description:

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.

Treatment:

Device: NICOM/FloTrac

Other: Crystalloid Fluid Challenge