Inflammatory Cytokine Variations in Traumatic Injury Responses

This study is currently recruiting participants.

Verified by University of Alabama at Birmingham, February 2009

First Received: January 3, 2008 Last Updated: February 12, 2009 History of Changes

Sponsors and Collaborators:	University of Alabama at Birmingham Orthopaedic Trauma Association
Information provided by:	University of Alabama at Birmingham
ClinicalTrials.gov Identifier:	NCT00593892

Purpose

The purpose of this study is to determine if the type of surgery (orthopaedic, general surgery, thoracic, etc.) affects the level of cytokines and thus potentially the risk of multisystem organ failure.

Condition
Inflammatory Cytokine Variations Following Traumatic Injury

MedlinePlus related topics: Surgery

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case-Only, Prospective
Official Title:	Cytokine Liberation From Secondary Surgery in the Setting of the Second Hit Syndrome

Further study details as provided by University of Alabama at Birmingham:

Primary Outcome Measures:

Determine if the type of surgery (orthopaedic, general surgery, thoracic, etc.) affects the level of cytokines and thus potentially the risk of multisystem organ failure. [ Time Frame: Duration of patient's hospitalization ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	150
Study Start Date:	May 2007
Estimated Study Completion Date:	May 2009
Estimated Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Groups/Cohorts
Observation All patients who are admitted to UAB for trauma, are 19 years of age and older, and whose Injury Severity Score (ISS) is greater than 9.

Show Detailed Description

Eligibility

Ages Eligible for Study:	19 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

UAB Patients treated for traumatic injuries

Criteria

Inclusion Criteria:

Adult patient 19 years and older
Sustained trauma injuries with Injury Severity Score greater than 9

Exclusion Criteria:

Under 19 years of age
Prisoners
Pregnancy
Unwilling or unable to give informed consent

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00593892

Contacts

Contact: Ashley R. Estes, MD	205-934-9545	Reed.Estes@ortho.uab.edu
Contact: David A. Volgas, MD	205-934-9545	David.Volgas@ortho.uab.edu

Locations

United States, Alabama
The University of Alabama at Birmingham, Orthopaedic Trauma	Recruiting
Birmingham, Alabama, United States, 35294
Contact: David A. Volgas, MD 205-934-9545 David.Volgas@ortho.uab.edu
Principal Investigator: Ashley R. Estes, MD

Sponsors and Collaborators

University of Alabama at Birmingham

Orthopaedic Trauma Association

Investigators

Study Director:	David A. Volgas, MD	The University of Alabama at Birmingham
Principal Investigator:	Ashley R. Estes, MD	The University of Alabama at Birmingham

More Information

No publications provided

Responsible Party:	The University of Alabama at Birmingham ( David A. Volgas, MD, Associate Professor of Surgery, Orthopaedic Division )
Study ID Numbers:	F070425005, OTA 000306032
Study First Received:	January 3, 2008
Last Updated:	February 12, 2009
ClinicalTrials.gov Identifier:	NCT00593892 History of Changes
Health Authority:	US:IRB

Keywords provided by University of Alabama at Birmingham:

Cytokine Levels
Traumatic Injury
Multisystem Organ Failure

Study placed in the following topic categories:

Multiple Organ Failure
Wounds and Injuries
Neoplasm Metastasis
Disorders of Environmental Origin

Additional relevant MeSH terms:

Wounds and Injuries
Disorders of Environmental Origin

ClinicalTrials.gov processed this record on May 07, 2009