Viewing Study NCT03598283



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Last Modification Date: 2024-10-26 @ 12:50 PM
Study NCT ID: NCT03598283
Status: WITHDRAWN
Last Update Posted: 2023-06-18
First Post: 2018-06-27

Brief Title: Liver Pancreas and Thyroid Function in Burn Patients
Sponsor: The University of Texas Medical Branch Galveston
Organization: The University of Texas Medical Branch Galveston

Study Overview

Official Title: A Prospective Study to Evaluate the Outcome of Liver Pancreas and Thyroid Function in Severely Burned Patients
Status: WITHDRAWN
Status Verified Date: 2023-06
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: The study PI has left the institution
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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 Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None