Liver, Pancreas and Thyroid Function in Burn Patients

June 15, 2023 updated by: The University of Texas Medical Branch, Galveston

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77047
        • Tina Mack-Moshay

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

6 months and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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).

Description

Inclusion Criteria:

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)

Exclusion Criteria:

  • Patient < 6 months
  • TBSA burned < 30 %

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Device: Ultrasound/transient elastography
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Liver stiffness (kPa)
Time Frame: 24 months
Measured via transient elastography
24 months
Controlled Attenuation Parameter
Time Frame: 24 months
Measured via transient elastography
24 months
Liver diameter (cm)
Time Frame: 24 months
Measured via Ultrasound
24 months
Platelet count (/nl)
Time Frame: 24 months
Liver function (blood tests)
24 months
High-density lipoprotein (mg/dl)
Time Frame: 24 months
Liver function (blood tests)
24 months
Low-density lipoprotein (mg/dl)
Time Frame: 24 months
Liver function (blood tests)
24 months
Triglycerides (mg/dl)
Time Frame: 24 months
Liver function (blood tests)
24 months
Cholesterol (mg/dl)
Time Frame: 24 months
Liver function (blood tests)
24 months
Alanine-aminotransferase (U/dl)
Time Frame: 24 months
Liver function (blood tests)
24 months
Aspartate-aminotransferase (U/dl)
Time Frame: 24 months
Liver function (blood tests)
24 months
Gamma glutamyltransferase (U/dl)
Time Frame: 24 months
Liver function (blood tests)
24 months
Alkaline phosphatase (U/dl)
Time Frame: 24 months
Liver function (blood tests)
24 months
Bilirubin (ng/dl)
Time Frame: 24 months
Liver function (blood tests)
24 months
Albumin (g/dl)
Time Frame: 24 months
Liver function (blood tests)
24 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Thyroid volume (ml)
Time Frame: 24 months
Measured via Ultrasound
24 months
T3 level (ng/dl)
Time Frame: 24 months
Thyroid function (blood tests)
24 months
T4 level (ng/dl)
Time Frame: 24 months
Thyroid function (blood tests)
24 months
Thyroid-stimulating hormone level (U/l)
Time Frame: 24 months
Thyroid function (blood tests)
24 months
Lipase (U/l)
Time Frame: 24 months
Pancreas function (blood tests)
24 months
Amylase (U/l)
Time Frame: 24 months
Pancreas function (blood tests)
24 months
Height (kg)
Time Frame: 24 months
General patient data
24 months
Weight (kg)
Time Frame: 24 months
General patient data
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The University of Texas Medical Branch, Galveston

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: David N. Herndon, MD, University of Texas

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 25, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 27, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 13, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 26, 2018

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 19, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 15, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 18-0053

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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