BurnsNCT03598283
Liver, Pancreas and Thyroid Function in Burn Patients
An observational study of Burns and Liver Fibroses, run by The University of Texas Medical Branch, Galveston at 1 site in United States.
Trial summary
The purpose of this study is to determine the extent to which severe burn injuries affect the morphology and function of liver, pancreas and thyroid. The evaluation of the liver will be performed non-invasively with liver fibrosis scores based on standard blood parameters and the measurement of liver stiffness… Read more about this study
- Who is it for?
- Ages 6 months and older
- Conditions the study is for
- Burns, Liver Fibroses, Pancreas Disease
- What is being tested?
- Ultrasound/transient elastography
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jun 2018to 30 Jun 2019
- 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 6 months and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The investigator's study population will include pediatric as well as adult patients with any type of burn injury or toxic epidermal necrolysis (TENS).
Who may be able to join
- Patients with partial thickness burns. Only patients who sign an IRB-approved consent (≥18 years old) or assent and have their legal guardian consenting to their participation (6 months - 17 years old) will be included.
- Patient age > 6 months
- Total body surface area (TBSA) burned ≥ 30 %
- Flame, electrical, scald or chemical injury, contact burn
- Toxic epidermal necrolysis (TENS)
Who cannot join
- Patient < 6 months
- TBSA burned < 30 %
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Study to Evaluate the Outcome of Liver, Pancreas and Thyroid Function in Severely Burned Patients
The purpose of this study is to determine the extent to which severe burn injuries affect the morphology and function of liver, pancreas and thyroid. The evaluation of the liver will be performed non-invasively with liver fibrosis scores based on standard blood parameters and the measurement of liver stiffness (correlated with liver fibrosis) and controlled attenuation parameter (CAP, correlated with hepatic steatosis) via transient elastography (FibroScan©, Echosens SA, Paris, France). The thyroid and the pancreas will be assessed via ultrasound (GE Medical Systems, Waukesha, USA) and standard blood parameters, respectively.
Read the detailed description
In this prospective study, the extent to which severe burn injuries affect the morphology and function of liver, pancreas and thyroid. The evaluation of the liver will be performed non-invasively with liver fibrosis scores based on standard blood parameters, the ultrasound-guided measurement of the liver size and the measurement of liver stiffness (correlated with liver fibrosis) and controlled attenuation parameter (CAP, correlated with hepatic steatosis) via transient elastography (FibroScan©, Echosens SA, Paris, France). The thyroid will be assessed by ultrasound and standard blood parameters and the pancreas by standard blood parameters only, respectively.
The patient will be enrolled during the first days on their admission to the intensive care burn unit, if they meet the inclusion criteria and no exclusion criteria are met. The first assessment of liver, pancreas and thyroid function will be performed within the first 48 hours of admission. The same measurements maybe be repeated approximately weekly until discharge, respectively. Furthermore at any follow-up visit up to 15 years post-burn if the patient consents to further participate in the study.
- Conditions
- Burns, Liver Fibroses, Pancreas Disease, Thyroid Diseases
- Being tested
- Ultrasound/transient elastography
- Medical subject headings
- Burns, Liver Cirrhosis, Pancreatic Diseases, Thyroid Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound/transient elastographyDevice
The evaluation of the liver will be performed non-invasively with liver fibrosis scores based on standard blood parameters, the ultrasound-guided measurement of the liver size and the measurement of liver stiffness (correlated with liver fibrosis) and controlled attenuation parameter (CAP, correlated with hepatic steatosis) via transient elastography (FibroScan©, Echosens SA, Paris, France). The thyroid will be assessed by ultrasound and standard blood parameters and the pancreas by standard blood parameters only, respectively.
| Study group | Role | What they receive |
|---|---|---|
| Severely burned patients | In this prospective study, the extent to which severe burn injuries affect the morphology and function of liver, pancreas and thyroid. The evaluation of the liver will be performed non-invasively with liver fibrosis scores based on standard blood parameters, the ultrasound-guided measurement of the liver size and the measurement of liver stiffness (correlated with liver fibrosis) and controlled attenuation parameter (CAP, correlated with hepatic steatosis) via transient elastography (FibroScan©, Echosens SA, Paris, France). The thyroid will be assessed by ultrasound and standard blood parameters and the pancreas by standard blood parameters only, respectively. Receives: Device: Ultrasound/transient elastography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Liver stiffness (kPa)
Measured via transient elastography
Measured: 24 months
Controlled Attenuation Parameter
Measured via transient elastography
Measured: 24 months
Liver diameter (cm)
Measured via Ultrasound
Measured: 24 months
Platelet count (/nl)
Liver function (blood tests)
Measured: 24 months
High-density lipoprotein (mg/dl)
Liver function (blood tests)
Measured: 24 months
Low-density lipoprotein (mg/dl)
Liver function (blood tests)
Measured: 24 months
Triglycerides (mg/dl)
Liver function (blood tests)
Measured: 24 months
Cholesterol (mg/dl)
Liver function (blood tests)
Measured: 24 months
Alanine-aminotransferase (U/dl)
Liver function (blood tests)
Measured: 24 months
Aspartate-aminotransferase (U/dl)
Liver function (blood tests)
Measured: 24 months
Gamma glutamyltransferase (U/dl)
Liver function (blood tests)
Measured: 24 months
Alkaline phosphatase (U/dl)
Liver function (blood tests)
Measured: 24 months
Bilirubin (ng/dl)
Liver function (blood tests)
Measured: 24 months
Albumin (g/dl)
Liver function (blood tests)
Measured: 24 months
Secondary outcomes (8)
Thyroid volume (ml)
Measured via Ultrasound
Measured: 24 months
T3 level (ng/dl)
Thyroid function (blood tests)
Measured: 24 months
T4 level (ng/dl)
Thyroid function (blood tests)
Measured: 24 months
Thyroid-stimulating hormone level (U/l)
Thyroid function (blood tests)
Measured: 24 months
Lipase (U/l)
Pancreas function (blood tests)
Measured: 24 months
Amylase (U/l)
Pancreas function (blood tests)
Measured: 24 months
Height (kg)
General patient data
Measured: 24 months
Weight (kg)
General patient data
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2018
- Study start25 Jun 2018
- Primary completion30 Jun 2019
- Study completion30 Jun 2019
Why it stopped: The study PI has left the institution.
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Texas Medical Branch, Galveston
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David N. Herndon, MD, Principal investigator, University of Texas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03598283
- Sponsor's protocol ID
- 18-0053
- Status last verified
- Jun 2023
- First submitted
- 27 Jun 2018
- Last updated
- 18 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study to Evaluate the Outcome of Liver, Pancreas and Thyroid Function in Severely Burned Patients
- ClinicalTrials.gov ID
- NCT03598283
- Acronym / sponsor ID
- 18-0053
- Conditions
- Burns, Liver Fibroses, Pancreas Disease, Thyroid Diseases
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: The study PI has left the institution.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- The University of Texas Medical Branch, GalvestonUniversity, hospital or other
- Study start
- 25 Jun 2018 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 26 Jul 2018 (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.
The purpose of this study is to determine the extent to which severe burn injuries affect the morphology and function of liver, pancreas and thyroid. The evaluation of the liver will be performed non-invasively with liver fibrosis scores based on standard blood parameters and the measurement of liver stiffness (correlated with liver fibrosis) and controlled attenuation parameter (CAP, correlated with hepatic steatosis) via transient elastography (FibroScan©, Echosens SA, Paris, France). The thyroid and the pancreas will be assessed via ultrasound (GE Medical Systems, Waukesha, USA) and standard blood parameters, respectively.
Detailed description
In this prospective study, the extent to which severe burn injuries affect the morphology and function of liver, pancreas and thyroid. The evaluation of the liver will be performed non-invasively with liver fibrosis scores based on standard blood parameters, the ultrasound-guided measurement of the liver size and the measurement of liver stiffness (correlated with liver fibrosis) and controlled attenuation parameter (CAP, correlated with hepatic steatosis) via transient elastography (FibroScan©, Echosens SA, Paris, France). The thyroid will be assessed by ultrasound and standard blood parameters and the pancreas by standard blood parameters only, respectively.
The patient will be enrolled during the first days on their admission to the intensive care burn unit, if they meet the inclusion criteria and no exclusion criteria are met. The first assessment of liver, pancreas and thyroid function will be performed within the first 48 hours of admission. The same measurements maybe be repeated approximately weekly until discharge, respectively. Furthermore at any follow-up visit up to 15 years post-burn if the patient consents to further participate in the study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Severely burned patients | – | Device: Ultrasound/transient elastographyIn this prospective study, the extent to which severe burn injuries affect the morphology and function of liver, pancreas and thyroid. The evaluation of the liver will be performed non-invasively with liver fibrosis scores based on standard blood parameters, the ultrasound-guided measurement of the liver size and the measurement of liver stiffness (correlated with liver fibrosis) and controlled attenuation parameter (CAP, correlated with hepatic steatosis) via transient elastography (FibroScan©, Echosens SA, Paris, France). The thyroid will be assessed by ultrasound and standard blood parameters and the pancreas by standard blood parameters only, respectively. |
Who may qualify
- Ages
- 6 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The investigator's study population will include pediatric as well as adult patients with any type of burn injury or toxic epidermal necrolysis (TENS).
Key inclusion criteria (5 listed)
- Patients with partial thickness burns. Only patients who sign an IRB-approved consent (≥18 years old) or assent and have their legal guardian consenting to their participation (6 months - 17 years old) will be included.
- Patient age > 6 months
- Total body surface area (TBSA) burned ≥ 30 %
- Flame, electrical, scald or chemical injury, contact burn
- Toxic epidermal necrolysis (TENS)
Key exclusion criteria (2 listed)
- Patient < 6 months
- TBSA burned < 30 %
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 |
|---|---|---|
| Ultrasound/transient elastographyThe evaluation of the liver will be performed non-invasively with liver fibrosis scores based on standard blood parameters, the ultrasound-guided measurement of the liver size and the measurement of liver stiffness (correlated with liver fibrosis) and controlled attenuation parameter (CAP, correlated with hepatic steatosis) via transient elastography (FibroScan©, Echosens SA, Paris, France). The thyroid will be assessed by ultrasound and standard blood parameters and the pancreas by standard blood parameters only, respectively. | Device | Severely burned patients |
Primary outcome
Liver stiffness (kPa)
Time frame: 24 months
Measured via transient elastography
Controlled Attenuation Parameter
Time frame: 24 months
Measured via transient elastography
Liver diameter (cm)
Time frame: 24 months
Measured via Ultrasound
Platelet count (/nl)
Time frame: 24 months
Liver function (blood tests)
High-density lipoprotein (mg/dl)
Time frame: 24 months
Liver function (blood tests)
Low-density lipoprotein (mg/dl)
Time frame: 24 months
Liver function (blood tests)
Triglycerides (mg/dl)
Time frame: 24 months
Liver function (blood tests)
Cholesterol (mg/dl)
Time frame: 24 months
Liver function (blood tests)
Alanine-aminotransferase (U/dl)
Time frame: 24 months
Liver function (blood tests)
Aspartate-aminotransferase (U/dl)
Time frame: 24 months
Liver function (blood tests)
Gamma glutamyltransferase (U/dl)
Time frame: 24 months
Liver function (blood tests)
Alkaline phosphatase (U/dl)
Time frame: 24 months
Liver function (blood tests)
Bilirubin (ng/dl)
Time frame: 24 months
Liver function (blood tests)
Albumin (g/dl)
Time frame: 24 months
Liver function (blood tests)
8 secondary outcomes
Thyroid volume (ml)
Time frame: 24 months
T3 level (ng/dl)
Time frame: 24 months
T4 level (ng/dl)
Time frame: 24 months
Thyroid-stimulating hormone level (U/l)
Time frame: 24 months
Lipase (U/l)
Time frame: 24 months
Amylase (U/l)
Time frame: 24 months
Height (kg)
Time frame: 24 months
Weight (kg)
Time frame: 24 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 18 Jun 2023.
- Individual participant dataSharing planned: Undecided
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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.
David N. Herndon, MD principal investigator
University of Texas
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 Burns and Liver Fibroses, run by The University of Texas Medical Branch, Galveston 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 5 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: withdrawn, as of the sponsor's last update on 18 Jun 2023. 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?
Liver stiffness (kPa) (time frame: 24 months). The study lists 14 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 18 Jun 2023.