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Invloed van Mannose-Binding Lectin Polymorfismen op Infectieuze Complicaties bij TraumapatiŽnten.


- candidate number5143
- NTR NumberNTR1625
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR12-jan-2009
- Secondary IDsNL17368.078.07 METC Erasmus MC
- Public TitleInvloed van Mannose-Binding Lectin Polymorfismen op Infectieuze Complicaties bij TraumapatiŽnten.
- Scientific TitleInfluence of Mannose-Binding Lectin Polymorphisms on Infectious Complications in Trauma Patients.
- ACRONYMN/A
- hypothesisDe studiehypothesen zijn:
1. TraumapatiŽnten (ISS>15) met MBL-deficiŽntie als gevolg van een variant MBL2 haplotype hebben een hogere gevoeligheid voor het ontwikkelen van ernstige (infectieuze) systemische complicaties;
2. TraumapatiŽnten (ISS>15) met MBL-deficiŽntie als gevolg van een variant MBL2 haplotype hebben een hogere kans op overlijden als gevolg van (infectieuze) complicaties tijdens een langdurige opname op de Intensive Care Unit.
- Healt Condition(s) or Problem(s) studiedPolytrauma
- Inclusion criteria1. Trauma patients with an ISS of 16 or higher:
2. Age between 18 and 70 years;
3. Compos mentis;
4. Informed consent.
- Exclusion criteria1. ISS<16;
2. Age <18 or >70 years;
3. Death within 24 hours after the trauma;
4. No informed consent;
5. Patients with a known immune disorder;
6. Use of immunosuppressive drugs.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-dec-2007
- planned closingdate31-dec-2011
- Target number of participants450
- InterventionsNone (observational study).
- Primary outcome1. Bacteremia (BSI);
2. Pneumonia;
3. Systemic Inflammatory Response Syndrome (SIRS);
4. Sepsis;
5. Septic shock.
- Secondary outcome1. Death within 3 months;
2. Surgical site infection;
3. Osteitis after osteosynthesis of fractures.
- TimepointsNot applicable; single venipuncture.
- Trial web siteN/A
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIESMD M.W.G.A. Bronkhorst
- CONTACT for SCIENTIFIC QUERIESMD M.W.G.A. Bronkhorst
- Sponsor/Initiator Erasmus MC, Trauma Research Unit department of Surgery
- Funding
(Source(s) of Monetary or Material Support)
OTC foundation
- PublicationsBronkhorst MWGA, Boyť NDA, Lomax MAZ, Vossen RHAM, Bakker J, Patka P, Van Lieshout EMM. Single Nucleotide Polymorphisms in the Toll-Like Receptor Pathway increase Susceptibility to Infections in Severely Injured Trauma Patients. J Trauma Acute Care Surg 2013 Mar;74(3):862-870.

Bronkhorst MWGA, Lomax MAZ, Vossen RHAM, Bakker J, Patka P, Van Lieshout EMM. Risk of infection and sepsis in severely injured patients related to single nucleotide polymorphisms in the lectin pathway. Br J Surg. 2013 Dec;100(13):1818-26.
- Brief summaryBackground of the study:
Infection and sepsis are serious complications that occur in up to 10% of trauma patients. Sepsis, bacteremia, (ventilator-associated) pneumonia and surgical site infections seriously hamper recovery, and may eventually lead to death. Resistance to infection is determined by the innate and the acquired immune systems. The innate immune system is the first line of defense against invading microorganisms. The complement system is part of the innate immune system and consists of three pathways: the classic, alternative and the lectin pathway. These are activated through different mechanisms but eventually all lead to activation of the C3 molecule. The central molecule in the lectin pathway is Mannose-Binding Lectin (MBL), a C-type serum lectin that is primarily produced by the liver. Binding of MBL to carbohydrates present on pathogens activates the lectin pathway of complement activation, resulting in opsonization and anti-microbial protection. Three frequently occurring single nucleotide polymorphisms (SNPs) are described in exon 1 of MBL-2 that are associated with abnormal polymerization of the MBL molecule, decreased serum concentrations, and strongly impaired function. Clinical studies have shown that single nucleotide polymorphisms (SNPs) in the MBL2 gene are associated with increased susceptibility to infections, especially in immune-compromised persons. In addition, SNPs in the promoter region and the 5í untranslated region of the MBL-2 gene reduce the promoter activity and, hence, result in reduced protein levels. Clinical studies indicate that SNPs in MBL-2 are a predisposing factor for infection: for example they (1) increase the chance of infection with Mycoplasma in patients with Primary Antibody Deficiency, (2) increase the risk of developing SARS, (3) enhance the chance of infectious complication in neutropenic oncology patients, and (4) increase the incidence of infection in patients with hematologic malignancy. These and other studies revealed that studying MBL variant alleles is of considerable clinical interest. During treatment, the immune system of trauma patients is often challenged, therefore on optimal immune status is important. Extrapolating from other studies resulted in the following study hypothesis: MBL-deficiency as a result of SNPs in the MBL-2 gene confers a major risk for the development of and mortality from (serious) infectious complications in trauma patients.

Objective of the study:
The aim of this study is to determine to what extent MBL-2 polymorphisms influence the outcome of Polytrauma patients. Serious (systemic) infections and local infections are the main outcome parameters. The MBLstatus will be measured by determining the MBL2 genotype, serum-MBL concentration, and the serum-MBL activity.

Study design:
Prospective, observational study.

Study population:
All trauma patients (ISS>15) between 18 and 70 years of age.

Primary study parameters/outcome of the study:
1. Bacteremia (BSI);
2. Pneumonia;
3. Systemic Inflammatory Response Syndrome (SIRS);
4. Sepsis;
5. Septic shock.

Secundary study parameters/outcome of the study (if applicable):
1. Death within 3 months;
2. Surgical site infection;
3. Osteitis after osteosynthesis of fractures.
- Main changes (audit trail)
- RECORD12-jan-2009 - 5-jan-2016


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