NCT03598283

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jun 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 25, 2018

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

June 27, 2018

Completed
29 days until next milestone

First Posted

Study publicly available on registry

July 26, 2018

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2019

Completed
Last Updated

June 18, 2023

Status Verified

June 1, 2023

Enrollment Period

1 year

First QC Date

June 27, 2018

Last Update Submit

June 15, 2023

Conditions

BurnsLiver FibrosesPancreas DiseaseThyroid Diseases

Outcome Measures

Primary Outcomes (14)

  • 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 Outcomes (8)

  • Thyroid volume (ml)

    24 months

  • T3 level (ng/dl)

    24 months

  • T4 level (ng/dl)

    24 months

  • Thyroid-stimulating hormone level (U/l)

    24 months

  • Lipase (U/l)

    24 months

  • +3 more secondary outcomes

Study Arms (1)

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

Interventions

Ultrasound/transient elastographyDEVICE

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.

Severely burned patients

Eligibility Criteria

Age6 Months+
Sexall(Gender-based eligibility)
Gender Eligibility DetailsPatients older than six months
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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).

You may qualify if:

  • 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)

You may not qualify if:

  • Patient \< 6 months
  • TBSA burned \< 30 %

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tina Mack-Moshay

Houston, Texas, 77047, United States

Location

MeSH Terms

Conditions

BurnsLiver CirrhosisPancreatic DiseasesThyroid Diseases

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Wounds and InjuriesLiver DiseasesDigestive System DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and SymptomsEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • David N. Herndon, MD

    University of Texas

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 27, 2018

First Posted

July 26, 2018

Study Start

June 25, 2018

Primary Completion

June 30, 2019

Study Completion

June 30, 2019

Last Updated

June 18, 2023

Record last verified: 2023-06

Locations

US(1)