Clinical Trial: Inflammatory Response After Muscle and Skeleton Trauma

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Inflammatory Response in Polytraumatized Patients

Brief Summary: The purpose of this study is to determine the inflammatory response after multiple trauma in humans.

Detailed Summary: Polytraumatized patients are via a systemic inflammatory response syndrome at high risk for an uneventful outcome in the posttraumatic phase. One of the main functions of the inflammatory response is the recognition and elimination of damaged tissues and microorganisms. In polytraumatized patients, a huge amount of damaged cells occurs which has to be eliminated by programmed cell death (apoptosis)without damaging surrounding tissues. It remains unclear whether, when and how an interplay of complement system, NF-kB, danger and pattern recognition receptors, apoptosis, mesenchymal stem cells and their regulation may be beneficial and harmful. Differing activation of the complement system, pro-inflammatory biomarkers and predisposing polymorphisms of response and receptor genes are expected to lead to varying outcome. Therefore, this prospective observational study will enroll n=60 polytraumatized patients with an ISS>18 to monitor longitudinally their inflammatory response after trauma and to find out whether there is a discriminating pattern of the cross talk between complement system, biomarkers and apoptosis in patients with beneficial or harmful outcome.
Sponsor: University of Ulm

Current Primary Outcome: Inflammatory pattern of complement activation, biomarkers and complement-regulating proteins (CRegs)on leukocytes [ Time Frame: 0, 1, 4, 12, 24, 48, 96, 120 und 240 h after trauma ]

Original Primary Outcome: Same as current

Current Secondary Outcome: inflammatory biomarkers, cell surface markers, apoptosis, functional polymorphisms, mesenchymal stem cells, severity of injury (ISS), infections, SIRS, sepsis, shock, organ dysfunctions, severity of disease, ICU length of stay, wound healing, mortality [ Time Frame: 0, 1, 4, 12, 24, 48, 96, 120 und 240 h after trauma for biochemical and immunological parameters; ISS on admission; scores on a daily basis; ICU and hospital death on discharge ]

Original Secondary Outcome: Same as current

Information By: University of Ulm

Dates:
Date Received: July 2, 2008
Date Started: April 2009
Date Completion:
Last Updated: December 16, 2015
Last Verified: December 2015