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Liver, Pancreas and Thyroid Function in Burn Patients

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ClinicalTrials.gov Identifier: NCT03598283
Recruitment Status : Recruiting
First Posted : July 25, 2018
Last Update Posted : July 25, 2018
Sponsor:
Information provided by (Responsible Party):
The University of Texas Medical Branch, Galveston

Brief 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 (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.

Condition or disease Intervention/treatment
Burns Liver Fibroses Pancreas Disease Thyroid Diseases Device: Ultrasound/transient elastography

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.


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Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Study to Evaluate the Outcome of Liver, Pancreas and Thyroid Function in Severely Burned Patients
Actual Study Start Date : June 25, 2018
Estimated Primary Completion Date : June 30, 2019
Estimated Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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.




Primary Outcome Measures :
  1. Liver stiffness (kPa) [ Time Frame: 24 months ]
    Measured via transient elastography

  2. Controlled Attenuation Parameter [ Time Frame: 24 months ]
    Measured via transient elastography

  3. Liver diameter (cm) [ Time Frame: 24 months ]
    Measured via Ultrasound

  4. Platelet count (/nl) [ Time Frame: 24 months ]
    Liver function (blood tests)

  5. High-density lipoprotein (mg/dl) [ Time Frame: 24 months ]
    Liver function (blood tests)

  6. Low-density lipoprotein (mg/dl) [ Time Frame: 24 months ]
    Liver function (blood tests)

  7. Triglycerides (mg/dl) [ Time Frame: 24 months ]
    Liver function (blood tests)

  8. Cholesterol (mg/dl) [ Time Frame: 24 months ]
    Liver function (blood tests)

  9. Alanine-aminotransferase (U/dl) [ Time Frame: 24 months ]
    Liver function (blood tests)

  10. Aspartate-aminotransferase (U/dl) [ Time Frame: 24 months ]
    Liver function (blood tests)

  11. Gamma glutamyltransferase (U/dl) [ Time Frame: 24 months ]
    Liver function (blood tests)

  12. Alkaline phosphatase (U/dl) [ Time Frame: 24 months ]
    Liver function (blood tests)

  13. Bilirubin (ng/dl) [ Time Frame: 24 months ]
    Liver function (blood tests)

  14. Albumin (g/dl) [ Time Frame: 24 months ]
    Liver function (blood tests)


Secondary Outcome Measures :
  1. Thyroid volume (ml) [ Time Frame: 24 months ]
    Measured via Ultrasound

  2. T3 level (ng/dl) [ Time Frame: 24 months ]
    Thyroid function (blood tests)

  3. T4 level (ng/dl) [ Time Frame: 24 months ]
    Thyroid function (blood tests)

  4. Thyroid-stimulating hormone level (U/l) [ Time Frame: 24 months ]
    Thyroid function (blood tests)

  5. Lipase (U/l) [ Time Frame: 24 months ]
    Pancreas function (blood tests)

  6. Amylase (U/l) [ Time Frame: 24 months ]
    Pancreas function (blood tests)

  7. Height (kg) [ Time Frame: 24 months ]
    General patient data

  8. Weight (kg) [ Time Frame: 24 months ]
    General patient data



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Patients older than six months
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).
Criteria

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 %

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03598283


Contacts
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Contact: Christian Tapking, MD 409 770 6964 chtapkin@utmb.edu

Locations
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United States, Texas
University of Texas Medical Branch Recruiting
Galveston, Texas, United States, 77550
Contact: Christian Tapking, MD    409-770-6964    chtapkin@utmb.edu   
Sponsors and Collaborators
The University of Texas Medical Branch, Galveston
Investigators
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Principal Investigator: David N Herndon, MD University of Texas

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Responsible Party: The University of Texas Medical Branch, Galveston
ClinicalTrials.gov Identifier: NCT03598283     History of Changes
Other Study ID Numbers: 18-0053
First Posted: July 25, 2018    Key Record Dates
Last Update Posted: July 25, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Liver Cirrhosis
Pancreatic Diseases
Thyroid Diseases
Endocrine System Diseases
Liver Diseases
Digestive System Diseases
Pancrelipase
Pancreatin
Gastrointestinal Agents