Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The study PI has left the institution.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ultrasound/transient elastography | Device | 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. |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Thyroid volume (ml) | Measured via Ultrasound | 24 months |
| T3 level (ng/dl) | Thyroid function (blood tests) | 24 months |
Not provided
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.
Exclusion Criteria:
Patients older than six months
Not provided
The investigator's study population will include pediatric as well as adult patients with any type of burn injury or toxic epidermal necrolysis (TENS).
Not provided
| Name | Affiliation | Role |
|---|---|---|
| David N. Herndon, MD | University of Texas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tina Mack-Moshay | Houston | Texas | 77047 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D002056 | Burns |
| D008103 | Liver Cirrhosis |
| D010182 | Pancreatic Diseases |
| D013959 | Thyroid Diseases |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D005355 | Fibrosis |
Not provided
Not provided
| ID | Term |
|---|---|
| D014463 | Ultrasonography |
| ID | Term |
|---|---|
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 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 |
| 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 |
| D010335 |
| Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D004700 | Endocrine System Diseases |