Cardiac Output Monitoring in Burn Patients

Non-invasive Cardiac Output Monitoring in Patients With Burn Injuries

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.

Study Overview

• Status: Withdrawn
• Conditions: Burns
• Intervention / Treatment: Device: NICOM (non-invasive cardiac output monitor)

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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30303
      • Grady Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NICOM; 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.	Device: NICOM (non-invasive cardiac output monitor); 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.
No Intervention: Control; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total volume of fluid given	The total volume of fluid given to the subjects in the first 24 hours	24 hours
Rate of pressor use	Defined as number of subjects that required pressor support (administration of cardiovascular supportive agents)	Duration of hospital stay, an expected average of 30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of pulmonary edema	Defined as number of subjects with pulmonary edema	Duration of hospital stay, an expected average of 30 days
Rate of acute renal failure	Defined as number of subjects with renal failure	Duration of hospital stay, an expected average of 30 days
Length of stay in intensive care unit (ICU)	Defined as the number of days from date of admission to date of first ICU discharge.	3 months
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.	3 months

Collaborators and Investigators

• Sponsor: Emory University
• Investigators: Principal Investigator: Rachael Williams, MD, Emory University

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2018
• Primary Completion (Anticipated): March 1, 2018
• Study Completion (Anticipated): March 1, 2018

Study Registration Dates

• First Submitted: March 26, 2015
• First Submitted That Met QC Criteria: March 26, 2015
• First Posted (Estimate): March 31, 2015

Study Record Updates

• Last Update Posted (Actual): February 28, 2018
• Last Update Submitted That Met QC Criteria: February 26, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: Cardiac output; Low blood pressure; Total Body Surface Area (TBSA)
• Additional Relevant MeSH Terms: Wounds and Injuries; Burns
• Other Study ID Numbers: IRB00078576

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes