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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
Information provided by (Responsible Party):

Study Description
Brief Summary:

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 Design

Study Type : Observational
Estimated Enrollment : 520 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Traumatic injury
ICU Patients with blunt or penetrating injury
Healthy volunteers

Outcome Measures

Primary Outcome Measures :
  1. 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.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Subjects to be recruited will consist of trauma patients and healthy volunteers:

Trauma patient cohort inclusion criteria:

  • Present for treatment of their acute, blunt or penetrating injuries to the University of Pittsburgh Medical Center within 6 hours of injury
  • Age greater than or equal to 18 years
  • Intact cervical spinal cord
  • Are admitted to the Intensive Care Unit

Trauma patient cohort exclusion criteria:

  • Anticipated survival < 24 hrs
  • Anticipated survival < 28 days due to pre-existing condition
  • Traumatic Brain injury (GCS ≤8 after ICU admission) AND brain CT abnormality within 12 hr of injury
  • Inability to obtain consent from the subject or their legally authorized representative.
  • Pre-existing immunosuppression
  • Transplant recipient
  • Chronic high doses of steroids (>20 mg prednisone equivalents/day)
  • Significant likelihood of high dose steroids (e.g. spinal cord injury)
  • Oncolytic drug(s) therapy within the past 14 days
  • Known HIV positive status and CD4 count < 200 cells/mm3
  • Admission to the ICU primary for substance withdrawal.
  • Inability to obtain 1st blood sample within 24 hours of injury.

Healthy volunteer cohort inclusion:

  • Age greater than or equal to 18 years
  • Weight > 110 pounds
  • no recent illness or infection in the last two weeks
  • no recent hospitalization or trauma in the last month

Healthy volunteer cohort exclusion:

  • wt < 110 lbs
  • infection or illness in the last two weeks
  • Hospitalization or trauma in the last month
Contacts and Locations

Information from the National Library of Medicine

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, MS 412-692-4338 stullsd@upmc.edu

United States, Pennsylvania
University of Pittsburgh Medical Center Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Principal Investigator: Jason L Sperry, MD         
Sponsors and Collaborators
National Institute of General Medical Sciences (NIGMS)
Principal Investigator: Jason L Sperry, MD UPMC Department of Surgery/Critical Care Medicine
More Information

Responsible Party: Dr Jason L Sperry, Professor of Surgery and Critical Care Medicine, National Institute of General Medical Sciences (NIGMS)
ClinicalTrials.gov Identifier: NCT00250523     History of Changes
Other Study ID Numbers: PRO 0801232
P50GM053789-09 ( U.S. NIH Grant/Contract )
First Posted: November 8, 2005    Key Record Dates
Last Update Posted: September 15, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Dr Jason L Sperry, National Institute of General Medical Sciences (NIGMS):
critical illness

Additional relevant MeSH terms:
Critical Illness
Disease Attributes
Pathologic Processes