Cardiac Output Monitoring in Burn Patients

Not Applicable

Withdrawn

• Conditions: Burns
• Interventions: Device: NICOM (non-invasive cardiac output monitor)

• Registration Number: NCT02404597
• Lead Sponsor: Emory University

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.

Study Timeline

• Study First Submitted: 2015-03-26
• Study First Submitted QC: 2015-03-26
• Study First Posted: 2015-03-31
• Study Start: 2018-01
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-26
• Last Update Posted: 2018-02-28
• Primary Completion: 2018-03
• Study Completion: 2018-03

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NICOM	NICOM (non-invasive cardiac output monitor)	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.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Grady Memorial Hospital; 🇺🇸 Atlanta, Georgia, United States