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Cardiac Output Monitoring in Burn Patients

Primary Purpose

Burns

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
NICOM (non-invasive cardiac output monitor)
Sponsored by
Emory University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Burns focused on measuring Cardiac output, Low blood pressure, Total Body Surface Area (TBSA)

Eligibility Criteria

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

Inclusion Criteria:

1) Burn greater than 20% TBSA (total body surface area)

Exclusion Criteria:

1) Burn less than 20% TBSA (total body surface area)

Sites / Locations

  • Grady Memorial Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

NICOM

Control

Arm Description

Subjects with burns greater than 20% total body surface area (TBSA) will have a NICOM placed on them after the first 24 hours of admission if subject has an episode of hypotension (mean arterial pressure < 65 or a systolic blood pressure < 90mmHg). The NICOM will generate a number that reflects stroke volume of the heart. If the number is greater than 10 percent, subject will be given a bolus of crystalloid fluids. If the number is less than 10 percent, subject will start a medication to raise the blood pressure. Physicians may also use traditional endpoints of resuscitation include base deficit values and urine output goals of 0.5cc/kg/hr as indications of adequate intravenous fluid resuscitation.

This is a retrospective comparison control group of patients with burns greater than 20% total body surface area (TBSA) admitted to the hospital from 7/1/2014-12/31/2014.

Outcomes

Primary Outcome Measures

Total volume of fluid given
The total volume of fluid given to the subjects in the first 24 hours
Rate of pressor use
Defined as number of subjects that required pressor support (administration of cardiovascular supportive agents)

Secondary Outcome Measures

Rate of pulmonary edema
Defined as number of subjects with pulmonary edema
Rate of acute renal failure
Defined as number of subjects with renal failure
Length of stay in intensive care unit (ICU)
Defined as the number of days from date of admission to date of first ICU discharge.
Length of hospital stay
Defined as the number of days from date of admission to date of first hospital discharge, regardless of if subject was discharged to home or other location.

Full Information

First Posted
March 26, 2015
Last Updated
February 26, 2018
Sponsor
Emory University
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1. Study Identification

Unique Protocol Identification Number
NCT02404597
Brief Title
Cardiac Output Monitoring in Burn Patients
Official Title
Non-invasive Cardiac Output Monitoring in Patients With Burn Injuries
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Withdrawn
Why Stopped
Potential participants have not yet been identified.
Study Start Date
January 2018 (Anticipated)
Primary Completion Date
March 2018 (Anticipated)
Study Completion Date
March 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Emory University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to describe the use of non-invasive cardiac output monitors (NICOM) in patients with burn injuries and to develop a protocol for NICOM in a burn unit.
Detailed Description
Appropriate fluid resuscitation in the first 24 hours after a burn injury directly influences patient outcome and morbidity. Currently, there is some controversy surrounding the over and under-resuscitation and endpoints of resuscitation using older fluid resuscitation formulas in patients with burn injury. The NICOM has been used in the resuscitation of patients with sepsis. The NICOM will be used in patients with burn injury to determine the patient's fluid responsiveness and the need for additional fluid boluses versus medications to increase the patient's blood pressure.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burns
Keywords
Cardiac output, Low blood pressure, Total Body Surface Area (TBSA)

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
NICOM
Arm Type
Experimental
Arm Description
Subjects with burns greater than 20% total body surface area (TBSA) will have a NICOM placed on them after the first 24 hours of admission if subject has an episode of hypotension (mean arterial pressure < 65 or a systolic blood pressure < 90mmHg). The NICOM will generate a number that reflects stroke volume of the heart. If the number is greater than 10 percent, subject will be given a bolus of crystalloid fluids. If the number is less than 10 percent, subject will start a medication to raise the blood pressure. Physicians may also use traditional endpoints of resuscitation include base deficit values and urine output goals of 0.5cc/kg/hr as indications of adequate intravenous fluid resuscitation.
Arm Title
Control
Arm Type
No Intervention
Arm Description
This is a retrospective comparison control group of patients with burns greater than 20% total body surface area (TBSA) admitted to the hospital from 7/1/2014-12/31/2014.
Intervention Type
Device
Intervention Name(s)
NICOM (non-invasive cardiac output monitor)
Intervention Description
The non-invasive cardiac output monitor (NICOM) will be used to tailor fluid management to optimize resuscitation if the patient has an episode of hypotension (defined as systolic blood pressure <100 or mean arterial pressure <65). NICOM consists of two electrodes placed on the patient's chest and back and uses bioreactance technology to transduce signals to compute hemodynamic parameters on an associated monitor. The electrodes will remain on the patient for twenty minutes. Once the electrodes are in place the patient's leg will be raised to 45 degrees and the monitor to which the electrodes are attached will generate a number that reflects stroke volume of the heart. The electrodes will be removed once this number is determined.
Primary Outcome Measure Information:
Title
Total volume of fluid given
Description
The total volume of fluid given to the subjects in the first 24 hours
Time Frame
24 hours
Title
Rate of pressor use
Description
Defined as number of subjects that required pressor support (administration of cardiovascular supportive agents)
Time Frame
Duration of hospital stay, an expected average of 30 days
Secondary Outcome Measure Information:
Title
Rate of pulmonary edema
Description
Defined as number of subjects with pulmonary edema
Time Frame
Duration of hospital stay, an expected average of 30 days
Title
Rate of acute renal failure
Description
Defined as number of subjects with renal failure
Time Frame
Duration of hospital stay, an expected average of 30 days
Title
Length of stay in intensive care unit (ICU)
Description
Defined as the number of days from date of admission to date of first ICU discharge.
Time Frame
3 months
Title
Length of hospital stay
Description
Defined as the number of days from date of admission to date of first hospital discharge, regardless of if subject was discharged to home or other location.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 1) Burn greater than 20% TBSA (total body surface area) Exclusion Criteria: 1) Burn less than 20% TBSA (total body surface area)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rachael Williams, MD
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Grady Memorial Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30303
Country
United States

12. IPD Sharing Statement

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Cardiac Output Monitoring in Burn Patients

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