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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03489577
Other study ID # 43279
Secondary ID
Status Terminated
Phase
First received March 29, 2018
Last updated March 29, 2018
Start date June 2014
Est. completion date June 1, 2016

Study information

Verified date March 2018
Source UMC Utrecht
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Terminated
Enrollment 15
Est. completion date June 1, 2016
Est. primary completion date June 1, 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- Admitted to the ICU

- Expected stay of at least 2 days

- Age: 18 - 80 years

- Informed consent (when proxy consent is obtained and the patient leaves the ICU in good mental health, personal informed consent is additionally necessary)

Exclusion Criteria:

- Immunosuppressive medication

- HIV and related diseases

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Netherlands University Medical Center Utrecht Utrecht

Sponsors (1)

Lead Sponsor Collaborator
UMC Utrecht

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 15 days following admission on ICU
Secondary 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) 15 days following admission to the ICU
Secondary Bactericidal capacity of neutrophils and pro-inflammatory complications The correlation between bactericidal function of neutrophils and the occurrence of pro-inflammatory complications (SIRS). 15 days following admission to the ICU
Secondary 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 15 days following admission on the ICU
Secondary Complement system and infectious complications The correlation between functionality of the complement system and the occurence of infectious complications. 15 days following admission to the ICU
Secondary T-cell proliferation and infectious complications The difference in suppression of T-cell proliferation in patients suffering infectious complications versus non-infectious patients. 15 days following admission on ICU
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