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

NCT02972827 | Unknown

• 1 other identifier: 15-21
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Severe Sepsis; Septic Shock

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Decrease in vasopressor dose, in response to fluid therapy guided by passive leg raise response using NICOM or Flotrac devices

  48 hours

Study Arms (1)

NICOM/FloTrac

EXPERIMENTAL

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; Other: Crystalloid Fluid Challenge

Interventions

NICOM/FloTrac DEVICE

Use of noninvasive cardiac output and minimally invasive cardiac output monitors

NICOM/FloTrac

Crystalloid Fluid Challenge OTHER

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.

NICOM/FloTrac

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All adult patients with severe sepsis or septic shock, who have arterial catheter placed with FloTrac monitor, with or without a central venous catheter.

You may not qualify if:

• Declination of consent
• Known allergy to adhesive
• Pregnancy
• Contraindication to raising legs or head to 45 degrees for 3 minute intervals

Sponsors & Collaborators

• Santa Barbara Cottage Hospital: lead

Study Sites (1)

Santa Barbara Cottage Hospital

Santa Barbara, California, 93105, United States

Location

MeSH Terms

Conditions

Sepsis; Shock, Septic

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2016
• First Posted: November 23, 2016
• Study Start: May 1, 2015
• Primary Completion: June 1, 2018
• Study Completion: May 1, 2022
• Last Updated: July 2, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)