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Cardiac Output Monitoring in Burn Patients

Non-invasive Cardiac Output Monitoring in Patients With Burn Injuries

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02404597
Enrollment
0
Registered
2015-03-31
Start date
2018-01-31
Completion date
2018-03-31
Last updated
2018-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Burns

Keywords

Cardiac output, Low blood pressure, Total Body Surface Area (TBSA)

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.

Interventions

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.

Sponsors

Emory University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Total volume of fluid given24 hoursThe total volume of fluid given to the subjects in the first 24 hours
Rate of pressor useDuration of hospital stay, an expected average of 30 daysDefined as number of subjects that required pressor support (administration of cardiovascular supportive agents)

Secondary

MeasureTime frameDescription
Rate of pulmonary edemaDuration of hospital stay, an expected average of 30 daysDefined as number of subjects with pulmonary edema
Rate of acute renal failureDuration of hospital stay, an expected average of 30 daysDefined as number of subjects with renal failure
Length of stay in intensive care unit (ICU)3 monthsDefined as the number of days from date of admission to date of first ICU discharge.
Length of hospital stay3 monthsDefined 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026