BurnsNCT01922960
Microcirculatory Assessment in Patients With Trauma and Severe Burns
A study testing micro-imaging in people with Burns and Trauma, run by University of South Alabama at 1 site in United States.
Trial summary
Predict the development of multiple organ failure in patients with trauma and severe burns. Read more about this study
- Who is it for?
- Ages 19 to 80 years
- What is being tested?
- micro-imaging
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Apr 2012to Feb 2014
- 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 19 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with severe burns/trauma ages 19-80. Patients undergoing elective abdominal or cardiothoracic surgery ages 19-69 years old
Who cannot join
- Patients undergoing elective surgery < 19 years old.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of South Alabama Medical Center
Mobile, Alabama, 36617
About this study
Predict the development of multiple organ failure in patients with trauma and severe burns.
Read the detailed description
Microvascular alterations are frequently seen in patients with sepsis, trauma, burns and those who are hemodynamically uncompensated(Shock).
The use of the Microscan is a non-invasive approach to visualize and assess impaired mucosal microcirculation in order to identify early on patients who are predisposed for MOF (multiple organ failure)
- Being tested
- micro-imaging
- Keywords
- trauma, multiple organ dysfunction syndrome
- Medical subject headings
- Burns, Wounds and Injuries, Multiple Organ Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
micro-imagingOther
micro-imaging
| Study group | Role | What they receive |
|---|---|---|
| micro-imaging | Other | Sublingual or subconjunctival micro-imaging of the microcirculation taken for 3 minute intervals at certain timepoints.
Timepoints for burn/trauma subjects: Day0, Day1,Day2,Day6 \& Day7 Timepoints for general surgery population: post-induction, prior to resection, after resection,\& closing of surgical wound. Receives: Other: micro-imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
dysfunctional capillary density correlates with development of multiple organ failure
Measured: approximately 1 year to assess outcome measure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2013 (estimated)
- Study start7 Apr 2012 (estimated)
- Primary completionFeb 2014
- Study completionFeb 2014
Why it stopped: investigators decided not to move forward with project
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.
- 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Alabama
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, William Richards, University of South Alabama
- Investigators
- William O Richards, MD, Study chair, University of South Alabama, Department of Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01922960
- Sponsor's protocol ID
- 12-092
- Status last verified
- Nov 2017
- First submitted
- 27 Jun 2013
- Last updated
- 29 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microcirculatory Assessment in Patients With Trauma and Severe Burns
- ClinicalTrials.gov ID
- NCT01922960
- Acronym / sponsor ID
- 12-092
- Keywords
- trauma, multiple organ dysfunction syndrome
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: investigators decided not to move forward with project
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of South AlabamaUniversity, hospital or other
- Study start
- 7 Apr 2012 (estimated)
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 14 Aug 2013 (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.
Predict the development of multiple organ failure in patients with trauma and severe burns.
Detailed description
Microvascular alterations are frequently seen in patients with sepsis, trauma, burns and those who are hemodynamically uncompensated(Shock).
The use of the Microscan is a non-invasive approach to visualize and assess impaired mucosal microcirculation in order to identify early on patients who are predisposed for MOF (multiple organ failure)
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| micro-imaging | Other | Other: micro-imagingSublingual or subconjunctival micro-imaging of the microcirculation taken for 3 minute intervals at certain timepoints. Timepoints for burn/trauma subjects: Day0, Day1,Day2,Day6 \& Day7 Timepoints for general surgery population: post-induction, prior to resection, after resection,\& closing of surgical wound. |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with severe burns/trauma ages 19-80. Patients undergoing elective abdominal or cardiothoracic surgery ages 19-69 years old
Key exclusion criteria (1 listed)
- Patients undergoing elective surgery < 19 years old.
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 |
|---|---|---|
| micro-imagingmicro-imaging | Other | micro-imaging |
Primary outcome
dysfunctional capillary density correlates with development of multiple organ failure
Time frame: approximately 1 year to assess outcome measure
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 29 Nov 2017.
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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.
William O Richards, MD study chair
University of South Alabama, Department of Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing micro-imaging in people with Burns and Trauma, run by University of South Alabama 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 29 Nov 2017. 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?
dysfunctional capillary density correlates with development of multiple organ failure (time frame: approximately 1 year to assess outcome measure). 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 29 Nov 2017.