Cardiac Output Monitoring in Burn Patients

Burns Clinical Trial

Official title:

Non-invasive Cardiac Output Monitoring in Patients With Burn Injuries

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02404597
• Other study ID #: IRB00078576
• Status: Withdrawn
• Phase: N/A
• First received: March 26, 2015
• Last updated: February 26, 2018
• Start date: January 2018
• Est. completion date: March 2018

Study information

• Verified date: February 2018
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Burns

Intervention

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.

Locations

Country	Name	City	State
United States	Grady Memorial Hospital	Atlanta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Emory University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total volume of fluid given	The total volume of fluid given to the subjects in the first 24 hours	24 hours
Primary	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	Rate of pulmonary edema	Defined as number of subjects with pulmonary edema	Duration of hospital stay, an expected average of 30 days
Secondary	Rate of acute renal failure	Defined as number of subjects with renal failure	Duration of hospital stay, an expected average of 30 days
Secondary	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
Secondary	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