Mathematical Modeling of the Acute Inflammatory Response Following Injury
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|ClinicalTrials.gov Identifier: NCT00250523|
Recruitment Status : Recruiting
First Posted : November 8, 2005
Last Update Posted : September 15, 2017
The purpose of this research study is to gather clinical and biologic information from severely injured patients to better understand and characterize the host response to injury and inflammation across several domains. This information may improve outcome prediction, improve clinical treatment of injured patients, and permit the construction of non-biologic computerized models of illness that can be utilized to represent the host response in future research efforts. This study is designed as the calibration of a mathematical model of this response with predictive capabilities.
The central hypothesis governing this study is that adaptive immune elements are crucial to determining the outcome of complex inflammatory scenarios. We propose to test these hypotheses in the following interrelated Specific Aims:
Specific Aim 1: To develop a robust mathematical model describing trauma/hemorrhage-induced inflammation in humans, its pathologic consequences, and possible therapies.
Specific Aim 2: To translate the mathematical model to humans and create software aimed at individualized clinical decision-making.
Specific Aim 3: To determine the prevalence of an IL-1 receptor-associated kinase (IRAK-1) variant haplotype located on the X-chromosome in an injured population, and to characterize differences in the pro-inflammatory response across gender, relative to the IRAK-1 haplotype.
Specific Aim 4: To determine if increased arginase activity previously observed in isolated peripheral blood mononuclear cells of trauma patients is a consequence of the presence of contaminating activated granulocytes or a particular subset of an arginase positive monocyte subset.
|Condition or disease|
|Trauma Critical Illness|
|Study Type :||Observational|
|Estimated Enrollment :||520 participants|
|Official Title:||Mathematical Modeling of the Acute Inflammatory Response Following Injury|
|Study Start Date :||February 2003|
|Estimated Primary Completion Date :||July 2018|
|Estimated Study Completion Date :||July 2020|
ICU Patients with blunt or penetrating injury
- Multiple Organ Failure [ Time Frame: 48 hours ]
Biospecimen Retention: Samples With DNA
For trauma injury cohort: The maximum blood volume collected over the 28 day period, if all samples are obtained, is approximately 90 cc. All standard precautions will be undertaken to assure minimal risk.
Blood samples will be obtained for genetic analysis of inflammatory gene polymorphisms. We will collect whole blood, serum and white cells.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00250523
|Contact: Stacy D Stull, MSfirstname.lastname@example.org|
|United States, Pennsylvania|
|University of Pittsburgh Medical Center||Recruiting|
|Pittsburgh, Pennsylvania, United States, 15213|
|Principal Investigator: Jason L Sperry, MD|
|Principal Investigator:||Jason L Sperry, MD||UPMC Department of Surgery/Critical Care Medicine|