An observational study in Multiple Trauma, Sepsis and Innate Immune Response, sponsored by UMC Utrecht. Terminated at 1 site in Netherlands. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2018-04-05.
Sponsored by UMC Utrecht · Observational
Patients admitted to the Intensive Care Unit after severe injury are prone to suffer from infectious complications and even sepsis. Despite tremendous efforts the etiology of this increased susceptibility to infectious pathogens is incompletely understood. Clinical signs and symptoms as well as current diagnostic clinical tests (WBC, CRP, cytokines, interleukines) lack sensitivity or specificity for adequate prediction of the development of infectious complications or sepsis.
Neutrophil granulocytes, cells of the innate immune system, play an important role in the defence against invading bacterial pathogens and are crucial in preventing fulminant infections. For successful eradication of a bacterium neutrophils need to exert specific functions: chemotaxis, migration, phagocytosis, degranulation and production of radical oxygen species. Much research has focused on the effect of trauma on neutrophil's individual capacities to kill bacteria with conflicting interpretations as a result. For adequate determination of the neutrophil's capacity to eradicate bacteria from tissue of trauma patients we developed novel in-vitro assays in which neutrophils are tested for all of these functions combined. This assay allows us to identify dysfunctional neutrophils adequately.
The main focus of this study is the determination of the functionality of aberrant neutrophils circulating in the peripheral blood of severly injured following trauma.
139 studies on the registry are indexed under Multiple Trauma; 32 are open to participants now.
This study's enrollment of 15 is below the median of 200 across 84 observational studies indexed under Multiple Trauma.
Browse Multiple Trauma studies →UMC Utrecht is the lead sponsor of 364 studies on the registry; 82 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Trauma patients likely to be admitted to the intensive care unit of the UMCU
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bactericidal capacity of neutrophils and sepsis
The correlation between reduced bactericidal capacity of neutrophils acquired from severely injured patients and the late occurrence of sepsis
Time frame: 15 days following admission on ICU
Bactericidal capacity of neutrophils and infectious complications
The correlation between reduced bacterial killing by neutrophils acquired from trauma patients and the occurrence of infectious complications (e.g pneumonia, meningitis, pericarditis, urinary tract infections, abdominal abscesses)
Time frame: 15 days following admission to the ICU
Bactericidal capacity of neutrophils and pro-inflammatory complications
The correlation between bactericidal function of neutrophils and the occurrence of pro-inflammatory complications (SIRS).
Time frame: 15 days following admission to the ICU
Priming capacity of neutrophils and infectious complications
The relationship between the responsiveness of neutrophils to a priming stimulus (fMLP) and the occurrence of infectious complications
Time frame: 15 days following admission on the ICU
Complement system and infectious complications
The correlation between functionality of the complement system and the occurence of infectious complications.
Time frame: 15 days following admission to the ICU
T-cell proliferation and infectious complications
The difference in suppression of T-cell proliferation in patients suffering infectious complications versus non-infectious patients.
Time frame: 15 days following admission on ICU
Plan to share: No
No publications or documents are linked to this record.
This study is terminated, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.
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