Liver, Pancreas and Thyroid Function in Burn Patients

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Prospective Study to Evaluate the Outcome of Liver, Pancreas and Thyroid Function in Severely Burned Patients

Conditions
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Burns, Liver Fibroses, Pancreas Disease, Thyroid Diseases

Intervention / Treatment
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* Device: Ultrasound/transient elastography


Participation Criteria
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Eligibility Criteria
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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 %

Ages Eligible for Study
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Minimum Age: 6 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Severely burned patients<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Liver stiffness (kPa) | Measured via transient elastography | 24 months | 
| Controlled Attenuation Parameter | Measured via transient elastography | 24 months | 
| Liver diameter (cm) | Measured via Ultrasound | 24 months | 
| Platelet count (/nl) | Liver function (blood tests) | 24 months | 
| High-density lipoprotein (mg/dl) | Liver function (blood tests) | 24 months | 
| Low-density lipoprotein (mg/dl) | Liver function (blood tests) | 24 months | 
| Triglycerides (mg/dl) | Liver function (blood tests) | 24 months | 
| Cholesterol (mg/dl) | Liver function (blood tests) | 24 months | 
| Alanine-aminotransferase (U/dl) | Liver function (blood tests) | 24 months | 
| Aspartate-aminotransferase (U/dl) | Liver function (blood tests) | 24 months | 
| Gamma glutamyltransferase (U/dl) | Liver function (blood tests) | 24 months | 
| Alkaline phosphatase (U/dl) | Liver function (blood tests) | 24 months | 
| Bilirubin (ng/dl) | Liver function (blood tests) | 24 months | 
| Albumin (g/dl) | Liver function (blood tests) | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Thyroid volume (ml) | Measured via Ultrasound | 24 months | 
| T3 level (ng/dl) | Thyroid function (blood tests) | 24 months | 
| T4 level (ng/dl) | Thyroid function (blood tests) | 24 months | 
| Thyroid-stimulating hormone level (U/l) | Thyroid function (blood tests) | 24 months | 
| Lipase (U/l) | Pancreas function (blood tests) | 24 months | 
| Amylase (U/l) | Pancreas function (blood tests) | 24 months | 
| Height (kg) | General patient data | 24 months | 
| Weight (kg) | General patient data | 24 months |