BurnsNCT02404597
Cardiac Output Monitoring in Burn Patients
A study testing NICOM (non-invasive cardiac output monitor) in people with Burns, run by Emory University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Burns
- What is being tested?
- NICOM (non-invasive cardiac output monitor)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2018to Mar 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1) Burn greater than 20% TBSA (total body surface area)
Who cannot join
- 1) Burn less than 20% TBSA (total body surface area)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Burns
- Being tested
- NICOM (non-invasive cardiac output monitor)
- Keywords
- Cardiac output, Low blood pressure, Total Body Surface Area (TBSA)
- Medical subject headings
- Burns, Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total volume of fluid given
The total volume of fluid given to the subjects in the first 24 hours
Measured: 24 hours
Rate of pressor use
Defined as number of subjects that required pressor support (administration of cardiovascular supportive agents)
Measured: Duration of hospital stay, an expected average of 30 days
Secondary outcomes (4)
Rate of pulmonary edema
Defined as number of subjects with pulmonary edema
Measured: Duration of hospital stay, an expected average of 30 days
Rate of acute renal failure
Defined as number of subjects with renal failure
Measured: 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.
Measured: 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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2015 (estimated)
- Study startJan 2018 (estimated)
- Primary completionMar 2018 (estimated)
- Study completionMar 2018 (estimated)
Why it stopped: Potential participants have not yet been identified.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BurnsStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rachael Williams, Emory University
- Investigators
- Rachael Williams, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02404597
- Sponsor's protocol ID
- IRB00078576
- Status last verified
- Feb 2018
- First submitted
- 26 Mar 2015
- Last updated
- 28 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive Cardiac Output Monitoring in Patients With Burn Injuries
- ClinicalTrials.gov ID
- NCT02404597
- Acronym / sponsor ID
- IRB00078576
- Conditions
- Burns
- Keywords
- Cardiac output, Low blood pressure, Total Body Surface Area (TBSA)
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Potential participants have not yet been identified.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- Jan 2018 (estimated)
- Primary completion
- Mar 2018 (estimated)
- Study completion
- Mar 2018 (estimated)
- First posted
- 31 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NICOM | Experimental | Device: 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1) Burn greater than 20% TBSA (total body surface area)
Key exclusion criteria (1 listed)
- 1) Burn less than 20% TBSA (total body surface area)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | NICOM |
Primary outcome
Total volume of fluid given
Time frame: 24 hours
The total volume of fluid given to the subjects in the first 24 hours
Rate of pressor use
Time frame: Duration of hospital stay, an expected average of 30 days
Defined as number of subjects that required pressor support (administration of cardiovascular supportive agents)
4 secondary outcomes
Rate of pulmonary edema
Time frame: Duration of hospital stay, an expected average of 30 days
Rate of acute renal failure
Time frame: Duration of hospital stay, an expected average of 30 days
Length of stay in intensive care unit (ICU)
Time frame: 3 months
Length of hospital stay
Time frame: 3 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rachael Williams, MD principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NICOM (non-invasive cardiac output monitor) in people with Burns, run by Emory University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 28 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total volume of fluid given (time frame: 24 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2018.