Inflammatory Response After Muscle and Skeleton Trauma - Full Text View

Sponsors and Collaborators:	University of Ulm University Hospital Ulm
Information provided by:	University of Ulm
ClinicalTrials.gov Identifier:	NCT00710411

Purpose

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

Condition
Multiple Trauma

MedlinePlus related topics: Injuries Sepsis Wounds

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case Control, Prospective
Official Title:	Inflammatory Response in Polytraumatized Patients

Further study details as provided by University of Ulm:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Biospecimen Retention: Samples With DNA

Biospecimen Description:

Whole blood, serum, white cells, and tissues will be retained.

Estimated Enrollment:	90
Study Start Date:	April 2009
Estimated Study Completion Date:	December 2011

Groups/Cohorts
A, 2 Polytraumatized patients with ISS > 18 and healthy controls

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes
Sampling Method:	Probability Sample

Study Population

Polytraumatized patients with an ISS > 18 Controls: healthy volunteers

Criteria

Inclusion Criteria:

multiple trauma injury, injury severity score (ISS) > 18 with
1. isolated fractures of the extremities
2. fractures of the extremities combined with blunt/penetrating visceral trauma
3. fractures of the extremities combined with blunt/penetrating thoracic trauma
4. isolated head injury with morphological changes in CCT
5. combination of points 1 - 4

Exclusion Criteria:

life expectancy < 24 hours
participation in other trials
ISS < 18
cardiopulmonary reanimation on the accident scene or dying immediately after hospital admission
age < 18 years
known or suspected pregnancy
patients with ray-treatment or chemotherapy within the last three months

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00710411

Contacts

Contact: Manfred M Weiss, MD, MBA	+49 - (0)731-500-60226	manfred.weiss@uniklinik-ulm.de
Contact: Markus M Huber-Lang, MD	+49 - (0)731-500-54569	markus.huber-lang@uniklinik-ulm.de

Locations

Germany
Clinic of Anesthesiology and Clinic of Traumatology, Hand-, Plastic-, and Reconstructive Surgery	Recruiting
Ulm, Germany, 89070
Contact: Manfred M Weiss, MD, MBA +49-(0)731-500-60226 manfred.weiss@uniklinik-ulm.de
Contact: Markus M Huber-Lang, MD +49-(0)731-500-54569 markus.huber-lang@uniklinik-ulm.de
Principal Investigator: Markus M Huber-Lang, MD
Sub-Investigator: Marion M Schneider, PhD
Sub-Investigator: Florian F Gebhard, MD
Sub-Investigator: Michael M Georgieff, MD
Sub-Investigator: Heidemarie H Suger-Wiedeck, MD
Sub-Investigator: Karl K Traeger, MD
Sub-Investigator: Uwe U Senftleben, MD
Sub-Investigator: Florian F Wagner, MD
Sub-Investigator: Miriam M Kalbitz, MD
Sub-Investigator: Mario M Perl, MD
Sub-Investigator: Doris D Henne-Bruns, MD
Principal Investigator: Ludger L Sunder-Plassmann, MD
Sub-Investigator: Dieter D Woischnek, MD
Sub-Investigator: Heiko H Reichel, MD
Sub-Investigator: Rolf R Brenner, MD
Sub-Investigator: Joerg J Fiedler, MD
Sub-Investigator: Barbara B Acker

Sponsors and Collaborators

University of Ulm

University Hospital Ulm

Investigators

Principal Investigator:

Manfred M Weiss, MD, MBA

Clinic of Anesthesiology, University Hospital Medical School, Steinhoevelstrasse 9, 89070 Ulm, Germany

More Information

No publications provided

Responsible Party:	Depts. Anesthesiology and. Traumatology, Hand-, Plastic-, Reconstr. Surgery Ulm ( Weiss Manfred/Associate Professor, MD, MBA; Huber-Lang Markus, Associate Professor, MD )
Study ID Numbers:	DFG KFO-200
Study First Received:	July 2, 2008
Last Updated:	April 1, 2009
ClinicalTrials.gov Identifier:	NCT00710411 History of Changes
Health Authority:	Germany: Federal Ministry of Education and Research

Keywords provided by University of Ulm:

humans
patients
polytrauma
complement
inflammation
inflammatory response
biomarkers
cytokines
cell surface markers
apoptosis
NF-kappaB
functional polymorphisms
mesenchymal stem cell
severity of injury
ISS

infections
systemic inflammatory response syndrome
SIRS
sepsis
severe sepsis
shock
organ dysfunctions
SOFA
severity of disease
APACHEII
SAPSII
SPAPS3
length of stay
wound healing
outcome

Study placed in the following topic categories:

Systemic Inflammatory Response Syndrome
Carisoprodol
Multiple Trauma
Sepsis

Shock
Wounds and Injuries
Disorders of Environmental Origin
Inflammation

Additional relevant MeSH terms:

Multiple Trauma
Wounds and Injuries
Disorders of Environmental Origin

ClinicalTrials.gov processed this record on May 07, 2009