Burns, Liver Fibroses, Pancreas Disease, Thyroid Diseases
Conditions
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.
Interventions
DEVICEUltrasound/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.
Sponsors
The University of Texas Medical Branch, Galveston
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
6 Months to No maximum
Healthy volunteers
No
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 %
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Albumin (g/dl) | 24 months | Liver function (blood tests) |
| Triglycerides (mg/dl) | 24 months | Liver function (blood tests) |
| Cholesterol (mg/dl) | 24 months | Liver function (blood tests) |
| Alanine-aminotransferase (U/dl) | 24 months | Liver function (blood tests) |
| Aspartate-aminotransferase (U/dl) | 24 months | Liver function (blood tests) |
| Gamma glutamyltransferase (U/dl) | 24 months | Liver function (blood tests) |
| Alkaline phosphatase (U/dl) | 24 months | Liver function (blood tests) |
| Bilirubin (ng/dl) | 24 months | Liver function (blood tests) |
| High-density lipoprotein (mg/dl) | 24 months | Liver function (blood tests) |
| Controlled Attenuation Parameter | 24 months | Measured via transient elastography |
| Liver diameter (cm) | 24 months | Measured via Ultrasound |
| Platelet count (/nl) | 24 months | Liver function (blood tests) |
| Liver stiffness (kPa) | 24 months | Measured via transient elastography |
| Low-density lipoprotein (mg/dl) | 24 months | Liver function (blood tests) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Thyroid volume (ml) | 24 months | Measured via Ultrasound |
| T3 level (ng/dl) | 24 months | Thyroid function (blood tests) |
| T4 level (ng/dl) | 24 months | Thyroid function (blood tests) |
| Thyroid-stimulating hormone level (U/l) | 24 months | Thyroid function (blood tests) |
| Lipase (U/l) | 24 months | Pancreas function (blood tests) |
| Amylase (U/l) | 24 months | Pancreas function (blood tests) |
| Height (kg) | 24 months | General patient data |
| Weight (kg) | 24 months | General patient data |
Countries
United States
Outcome results
None listed