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

Primary Purpose

Severe Sepsis, Septic Shock

Status

Unknown status

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

NICOM/FloTrac

Crystalloid Fluid Challenge

About this trial

This is an interventional diagnostic trial for Severe Sepsis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Santa Barbara Cottage Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

NICOM/FloTrac

Arm 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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

NCT ID

NCT02972827

First Posted

October 30, 2016

Last Updated

June 30, 2021

Sponsor

Santa Barbara Cottage Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02972827

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2021

Overall Recruitment Status

Unknown status

Study Start Date

May 2015 (Actual)

Primary Completion Date

June 2018 (Actual)

Study Completion Date

May 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Santa Barbara Cottage Hospital

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Severe Sepsis, Septic Shock

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

38 (Actual)

8. Arms, Groups, and Interventions

Arm Title

NICOM/FloTrac

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

NICOM/FloTrac

Intervention Description

Use of noninvasive cardiac output and minimally invasive cardiac output monitors

Intervention Type

Other

Intervention Name(s)

Crystalloid Fluid Challenge

Intervention Description

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.

Primary Outcome Measure Information:

Title

Number of participants who have agreement or disagreement between passive leg raise response and subsequent intravenous fluid challenge

Description

Time Frame

15 minutes

Secondary Outcome Measure Information:

Title

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

Time Frame

48 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Santa Barbara Cottage Hospital

City

Santa Barbara

State/Province

California

ZIP/Postal Code

93105

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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