Cardiac Output Monitoring in Burn Patients

NCT02404597 | Withdrawn FDA Device

• 1 other identifier: IRB00078576
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Burns

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Rate of pulmonary edema

  Duration of hospital stay, an expected average of 30 days

• Rate of acute renal failure

  Duration of hospital stay, an expected average of 30 days

• Length of stay in intensive care unit (ICU)

  3 months

• Length of hospital stay

  3 months

Study Arms (2)

NICOM

EXPERIMENTAL

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)

Control

NO INTERVENTION

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.

Interventions

NICOM (non-invasive cardiac output monitor) DEVICE

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.

NICOM

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Emory University: lead

Study Sites (1)

Grady Memorial Hospital

Atlanta, Georgia, 30303, United States

Location

MeSH Terms

Conditions

Burns; Hypotension

Condition Hierarchy (Ancestors)

Wounds and Injuries; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Rachael Williams, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate

Study Record Dates

• First Submitted: March 26, 2015
• First Posted: March 31, 2015
• Study Start: January 1, 2018
• Primary Completion: March 1, 2018
• Study Completion: March 1, 2018
• Last Updated: February 28, 2018

Record last verified: 2018-02

Locations

US (1)