Liver, Pancreas and Thyroid Function in Burn Patients

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Burns; Thyroid Diseases; Pancreas Disease; Liver Fibroses
• Intervention / Treatment: Device: Ultrasound/transient elastography

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 Type: Observational

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77047
      • Tina Mack-Moshay

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The investigator's study population will include pediatric as well as adult patients with any type of burn injury or toxic epidermal necrolysis (TENS).

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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.

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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: The University of Texas Medical Branch, Galveston
• Investigators: Principal Investigator: David N. Herndon, MD, University of Texas

Study record dates

Study Major Dates

• Study Start (Actual): June 25, 2018
• Primary Completion (Actual): June 30, 2019
• Study Completion (Actual): June 30, 2019

Study Registration Dates

• First Submitted: June 27, 2018
• First Submitted That Met QC Criteria: July 13, 2018
• First Posted (Actual): July 26, 2018

Study Record Updates

• Last Update Posted (Estimated): June 19, 2023
• Last Update Submitted That Met QC Criteria: June 15, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Endocrine System Diseases; Liver Diseases; Fibrosis; Liver Cirrhosis; Thyroid Diseases; Pancreatic Diseases
• Other Study ID Numbers: 18-0053

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No