Mathematical Modeling of the Acute Inflammatory Response Following Injury

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

520 participants

Study Classification

OBSERVATIONAL

Study Start Date

2003-02-28

Study Completion Date

2022-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Inflammation and the Host Response to Injury (Trauma)

NCT00257231

Trauma Burns Multiple Organ Failure

COMPLETED

Inflammation and the Host Response to Injury (Burns)

NCT00257244

Trauma Burns Multiple Organ Failure

COMPLETED

Transcriptomic Profiling in Severely Injured Patients

NCT02508272

Trauma Inflammation Sepsis

COMPLETED

Inflammation and Infection in Trauma, Role in Posttraumatic Complications

NCT00192907

Trauma

UNKNOWN

The Role of Brain-Bone Marrow-Gut Interaction Following Major Trauma

NCT06606119

Trauma Injury Trauma Critical Illness +3 more

RECRUITING

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Trauma Critical Illness

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Traumatic injury

ICU Patients with blunt or penetrating injury

No interventions assigned to this group

2

Healthy volunteers

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes