Clinical trial NCT03598283: Liver, Pancreas and Thyroid Function in Burn Patients
Official title: A Prospective Study to Evaluate the Outcome of Liver, Pancreas and Thyroid Function in Severely Burned Patients
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Burns
Liver Fibroses
Pancreas Disease
Thyroid Diseases
Lead sponsor: The University of Texas Medical Branch, Galveston
Sponsor class: OTHER
First posted: 2018-07-26
Enrollment: 0
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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).

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.

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.

Eligibility 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 %

Primary outcomes:
measure: Liver stiffness (kPa)
timeFrame: 24 months
measure: Controlled Attenuation Parameter
timeFrame: 24 months
measure: Liver diameter (cm)
timeFrame: 24 months
measure: Platelet count (/nl)
timeFrame: 24 months
measure: High-density lipoprotein (mg/dl)
timeFrame: 24 months
measure: Low-density lipoprotein (mg/dl)
timeFrame: 24 months
measure: Triglycerides (mg/dl)
timeFrame: 24 months
measure: Cholesterol (mg/dl)
timeFrame: 24 months
measure: Alanine-aminotransferase (U/dl)
timeFrame: 24 months
measure: Aspartate-aminotransferase (U/dl)
timeFrame: 24 months
measure: Gamma glutamyltransferase (U/dl)
timeFrame: 24 months
measure: Alkaline phosphatase (U/dl)
timeFrame: 24 months
measure: Bilirubin (ng/dl)
timeFrame: 24 months
measure: Albumin (g/dl)
timeFrame: 24 months
Secondary outcomes:
measure: Thyroid volume (ml)
timeFrame: 24 months
measure: T3 level (ng/dl)
timeFrame: 24 months
measure: T4 level (ng/dl)
timeFrame: 24 months
measure: Thyroid-stimulating hormone level (U/l)
timeFrame: 24 months
measure: Lipase (U/l)
timeFrame: 24 months
measure: Amylase (U/l)
timeFrame: 24 months
measure: Height (kg)
timeFrame: 24 months
measure: Weight (kg)
timeFrame: 24 months
Other outcomes:
Locations:
city: Houston
country: United States
facility: Tina Mack-Moshay
state: Texas
Study officials:
affiliation: University of Texas
name: David N. Herndon, MD
role: PRINCIPAL_INVESTIGATOR
References: