Liver, Pancreas and Thyroid Function in Burn Patients

Withdrawn

• Conditions: Burns; Liver Fibroses; Thyroid Diseases; Pancreas Disease
• Interventions: Device: Ultrasound/transient elastography

• Registration Number: NCT03598283
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2018-06-25
• Study First Submitted: 2018-06-27
• Study First Submitted QC: 2018-07-13
• Study First Posted: 2018-07-26
• Primary Completion: 2019-06-30
• Study Completion: 2019-06-30
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-15
• Last Update Posted: 2023-06-18

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 %

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Severely burned patients	Ultrasound/transient elastography	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.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Tina Mack-Moshay; 🇺🇸 Houston, Texas, United States