BurnsNCT01812941
Evaluation of Mitochondrial Dysfunction in Severe Burn and Trauma Patients
A study testing trauma: blood collection, healthy volunteers: blood collection and Burn: blood collection in people with Burns and Trauma, run by University of South Alabama at 1 site in United States.
Trial summary
The purpose of this project is to evaluate the level of mitochondrial dysfunction several patient populations: Burn, trauma, and control group of healthy volunteers. Study hypothesis: Increased plasma concentrations of a newly discovered inflammatory mediated, called mtDNA DAMPS associated with the occurrence of… Read more about this study
- Who is it for?
- Ages 19 to 70 yearsHealthy volunteers can take part
- What is being tested?
- trauma: blood collection, healthy volunteers: blood collection and Burn: blood collection
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2011to Dec 2021
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Burn injury must be less than 24 hours old at time of initial sampling
- Burn must be 2nd or 3rd degree and at least 10% TBSA
- ISS (injury severity score) > 15
Who cannot join
- Burn injury/trauma injury > than 24hours old at time of initial sampling
- Burn < 10% total body surface area.
- Evidence of active infection on admission in the burn subjects.
- < 19 years of age and > 70 years
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of South Alabama Medical Center
Mobile, Alabama, 36617
Jon Simmons, MD, 251-471-7971, jdsimmons@southalabama.edu
Mark Gillespie, PHD, 251-460-6497, mgillesp@southalabama.edu
About this study
The purpose of this project is to evaluate the level of mitochondrial dysfunction several patient populations: Burn, trauma, and control group of healthy volunteers.
Study hypothesis: Increased plasma concentrations of a newly discovered inflammatory mediated, called mtDNA DAMPS associated with the occurrence of multi-organ dysfunction syndrome in severly injured patients.
As the severity of a burn injury or trauma injury increase, so will systemic mitochondrial dysfunction.
Read the detailed description
Increased plasma concentrations of a newly discovered inflammatory mediated, called mtDNA DAMPS associated with the occurrence of multi-organ dysfunction syndrome in severly injured patients.
A normal healthy sub-population will be used as a control.
- Being tested
- trauma: blood collection, healthy volunteers: blood collection, Burn: blood collection
- Keywords
- burns, trauma
- Medical subject headings
- Burns, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
trauma: blood collectionOther
Blood samples collected at certain timepoints. Time points for burn/trauma subjects: Day0,Day1,Day2,and Day6 and Day7.
healthy volunteers: blood collectionOther
blood collected at designated time intervals
Burn: blood collectionOther
blood collected at designated time intervals
| Study group | Role | What they receive |
|---|---|---|
| Burn: blood collection | Other | Procedure: Blood draws as the intervention. Receives: Other: Burn: blood collection |
| trauma: blood collection | Other | blood to be collected at different time intervals. Blood draw as the intervention Receives: Other: trauma: blood collection |
| healthy volunteers: blood collection | Other | Blood draws as the intervention Receives: Other: healthy volunteers: blood collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma mtDNA DAMPs concentration
Plasma mtDNA DAMPs concentration
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 posted18 Mar 2013 (estimated)
- Study startSep 2011
- Primary completionDec 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of South Alabama
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jon Simmons, University of South Alabama
- Investigators
- Jon Simmons, MD, Principal investigator, University of South Alabama, Department of Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01812941
- Sponsor's protocol ID
- 11-212
- Status last verified
- May 2021
- First submitted
- 13 Mar 2013
- Last updated
- 28 May 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Simmons JD, Lee YL, Mulekar S, Kuck JL, Brevard SB, Gonzalez RP, Gillespie MN, Richards WO. Elevated levels of plasma mitochondrial DNA DAMPs are linked to clinical outcome in severely injured human subjects. Ann Surg. 2013 Oct;258(4):591-6; discussion 596-8. doi: 10.1097/SLA.0b013e3182a4ea46.
PubMed 23979273
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Mitochondrial Dysfunction in Severe Burn and Trauma Patients
- ClinicalTrials.gov ID
- NCT01812941
- Acronym / sponsor ID
- 11-212
- Keywords
- burns, trauma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of South AlabamaUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 18 Mar 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.
The purpose of this project is to evaluate the level of mitochondrial dysfunction several patient populations: Burn, trauma, and control group of healthy volunteers.
Study hypothesis: Increased plasma concentrations of a newly discovered inflammatory mediated, called mtDNA DAMPS associated with the occurrence of multi-organ dysfunction syndrome in severly injured patients.
As the severity of a burn injury or trauma injury increase, so will systemic mitochondrial dysfunction.
Detailed description
Increased plasma concentrations of a newly discovered inflammatory mediated, called mtDNA DAMPS associated with the occurrence of multi-organ dysfunction syndrome in severly injured patients.
A normal healthy sub-population will be used as a control.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Burn: blood collection | Other | Other: Burn: blood collectionProcedure: Blood draws as the intervention. |
| trauma: blood collection | Other | Other: trauma: blood collectionblood to be collected at different time intervals. Blood draw as the intervention |
| healthy volunteers: blood collection | Other | Other: healthy volunteers: blood collectionBlood draws as the intervention |
Who may qualify
- Ages
- 19 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Burn injury must be less than 24 hours old at time of initial sampling
- Burn must be 2nd or 3rd degree and at least 10% TBSA
- ISS (injury severity score) > 15
Key exclusion criteria (4 listed)
- Burn injury/trauma injury > than 24hours old at time of initial sampling
- Burn < 10% total body surface area.
- Evidence of active infection on admission in the burn subjects.
- < 19 years of age and > 70 years
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 |
|---|---|---|
| trauma: blood collectionBlood samples collected at certain timepoints. Time points for burn/trauma subjects: Day0,Day1,Day2,and Day6 and Day7. | Other | trauma: blood collection |
| healthy volunteers: blood collectionblood collected at designated time intervals | Other | healthy volunteers: blood collection |
| Burn: blood collectionblood collected at designated time intervals | Other | Burn: blood collection |
Primary outcome
Plasma mtDNA DAMPs concentration
Time frame: approximately 1 year to assess outcome measure
Plasma mtDNA DAMPs concentration
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2021.
- Derived from this study: PubMed 23979273Simmons JD, Lee YL, Mulekar S, Kuck JL, Brevard SB, Gonzalez RP, Gillespie MN, Richards WO. Elevated levels of plasma mitochondrial DNA DAMPs are linked to clinical outcome in severely injured human subjects. Ann Surg. 2013 Oct;258(4):591-6; discussion 596-8. doi: 10.1097/SLA.0b013e3182a4ea46.
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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.
Jon Simmons, MD principal investigator
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 trauma: blood collection, healthy volunteers: blood collection and Burn: blood collection 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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 28 May 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jon Simmons, MD (251-471-7971, jdsimmons@health.southalabama.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma mtDNA DAMPs concentration (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?
On the ClinicalTrials.gov record for NCT01812941, which also lists 1 linked publication.
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 May 2021.