Liver, Pancreas and Thyroid Function in Burn Patients

Burns Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03598283
• Other study ID #: 18-0053
• Status: Withdrawn
• Start date: June 25, 2018
• Est. completion date: June 30, 2019

Study information

• Verified date: June 2023
• Source: The University of Texas Medical Branch, Galveston
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 30, 2019
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months and older

Eligibility

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 %

Related Conditions & MeSH terms

• Burns
• Liver Cirrhosis
• Liver Fibroses
• Pancreas Disease
• Pancreatic Diseases
• Thyroid Diseases

Intervention

Device:
• Ultrasound/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.

Locations

Country	Name	City	State
United States	Tina Mack-Moshay	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Medical Branch, Galveston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Liver stiffness (kPa)	Measured via transient elastography	24 months
Primary	Controlled Attenuation Parameter	Measured via transient elastography	24 months
Primary	Liver diameter (cm)	Measured via Ultrasound	24 months
Primary	Platelet count (/nl)	Liver function (blood tests)	24 months
Primary	High-density lipoprotein (mg/dl)	Liver function (blood tests)	24 months
Primary	Low-density lipoprotein (mg/dl)	Liver function (blood tests)	24 months
Primary	Triglycerides (mg/dl)	Liver function (blood tests)	24 months
Primary	Cholesterol (mg/dl)	Liver function (blood tests)	24 months
Primary	Alanine-aminotransferase (U/dl)	Liver function (blood tests)	24 months
Primary	Aspartate-aminotransferase (U/dl)	Liver function (blood tests)	24 months
Primary	Gamma glutamyltransferase (U/dl)	Liver function (blood tests)	24 months
Primary	Alkaline phosphatase (U/dl)	Liver function (blood tests)	24 months
Primary	Bilirubin (ng/dl)	Liver function (blood tests)	24 months
Primary	Albumin (g/dl)	Liver function (blood tests)	24 months
Secondary	Thyroid volume (ml)	Measured via Ultrasound	24 months
Secondary	T3 level (ng/dl)	Thyroid function (blood tests)	24 months
Secondary	T4 level (ng/dl)	Thyroid function (blood tests)	24 months
Secondary	Thyroid-stimulating hormone level (U/l)	Thyroid function (blood tests)	24 months
Secondary	Lipase (U/l)	Pancreas function (blood tests)	24 months
Secondary	Amylase (U/l)	Pancreas function (blood tests)	24 months
Secondary	Height (kg)	General patient data	24 months
Secondary	Weight (kg)	General patient data	24 months