Inflammatory ResponseNCT04252651
Association of Cytokines With the Development of Complications in Burn and Toxic Epidermal Necrolysis (TENS) Patients
An observational study of Inflammatory Response and Multi Organ Failure, run by Joseph M. Still Research Foundation, Inc. at 1 site in United States.
Trial summary
This study will involve blood draws to test for specific cytokines. The study goal is to gain a better understanding of the role of inflammatory response in the development of specific complications in burn and TENS patients. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Inflammatory Response, Multi Organ Failure, Nosocomial Infection
- What is being tested?
- Blood Draw
- How many people
- 65 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Oct 2019to Dec 2022
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Samples size will be patients from the burn ICU.
Who may be able to join
- is ≥18 years of age
- has been admitted to the Joseph M. Still Burn Center at Doctors Hospital Augusta with a burn diagnosis, or TENS OR SJS diagnosis (confirmed or non-confirmed), with an expected length of stay to be at least 7 days
- the subject or their legally authorized representative is able to provide informed consent
- has a negative urine or serum pregnancy test at screening (if female and has potential for pregnancy)
Who cannot join
- is moribund, or in the opinion of the investigator is not expected to survive
- has sustained an electrical burn
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Joseph M. Still Burn Center at Doctors Hospital
Augusta, Georgia, 30909
Joan Wilson, 706-364-2966, joan.wilson@jmsresearchfoundation.org
Michael Quinn, MD
About this study
This study will involve blood draws to test for specific cytokines. The study goal is to gain a better understanding of the role of inflammatory response in the development of specific complications in burn and TENS patients.
- Being tested
- Blood Draw
- Medical subject headings
- Multiple Organ Failure, Cross Infection, Venous Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood DrawOther
This study will involve blood draws to test for specific cytokines
| Study group | Role | What they receive |
|---|---|---|
| Blood Draw | This study will involve blood draws to test for specific cytokines Receives: Other: Blood Draw |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cytokine Response that develops into complications
The number of burn and TENS patients that develop subsequent medical complications
Measured: up to one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start2 Oct 2019
- Primary completionOct 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory ResponseStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 65 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Joseph M. Still Research Foundation, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Quinn, MD, Principal investigator, Joseph M. Still Research Foundation, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04252651
- Sponsor's protocol ID
- JMSRF-CYT-P04
- Status last verified
- Aug 2021
- First submitted
- 28 Jan 2020
- Last updated
- 25 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study results will be analyzed, and study data presented at an appropriate related Congress meeting. Journal publication in a related peer-reviewed journal would be expected after presentation.
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Cytokines With the Development of Complications in Burn and Toxic Epidermal Necrolysis (TENS) Patients
- ClinicalTrials.gov ID
- NCT04252651
- Acronym / sponsor ID
- JMSRF-CYT-P04
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- Joseph M. Still Research Foundation, Inc.University, hospital or other
- Study start
- 2 Oct 2019 (actual)
- Primary completion
- Oct 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 5 Feb 2020 (actual)
- 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.
This study will involve blood draws to test for specific cytokines. The study goal is to gain a better understanding of the role of inflammatory response in the development of specific complications in burn and TENS patients.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Blood Draw | – | Other: Blood DrawThis study will involve blood draws to test for specific cytokines |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Samples size will be patients from the burn ICU.
Key inclusion criteria (4 listed)
- is ≥18 years of age
- has been admitted to the Joseph M. Still Burn Center at Doctors Hospital Augusta with a burn diagnosis, or TENS OR SJS diagnosis (confirmed or non-confirmed), with an expected length of stay to be at least 7 days
- the subject or their legally authorized representative is able to provide informed consent
- has a negative urine or serum pregnancy test at screening (if female and has potential for pregnancy)
Key exclusion criteria (2 listed)
- is moribund, or in the opinion of the investigator is not expected to survive
- has sustained an electrical burn
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 |
|---|---|---|
| Blood DrawThis study will involve blood draws to test for specific cytokines | Other | Blood Draw |
Primary outcome
Cytokine Response that develops into complications
Time frame: up to one year
The number of burn and TENS patients that develop subsequent medical complications
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2021.
- Individual participant dataSharing planned: Yes. Study results will be analyzed, and study data presented at an appropriate related Congress meeting. Journal publication in a related peer-reviewed journal would be expected after presentation.
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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.
Michael Quinn, MD principal investigator
Joseph M. Still Research Foundation, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammatory Response and Multi Organ Failure, run by Joseph M. Still Research Foundation, Inc. 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 4 inclusion and 2 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 25 Aug 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 Joan Wilson (7063642966, joan.wilson@jmsresearchfoundation.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cytokine Response that develops into complications (time frame: up to one year). 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 25 Aug 2021.