POSEIDON: The Role of Post-traumatic Inhibition of the Innate and Adaptive Immune System in the Development of Infectious Complications in Severely Injured Patients

Sponsor

UMC Utrecht (Other)

Overall Status

Terminated

CT.gov ID

NCT03489577

Collaborator

(none)

Enrollment

Location

Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Multiple Trauma Sepsis Innate Immune Response Disorder of Neutrophils Multiple Organ Dysfunction Syndrome

Study Design

Study Type:

Observational

Actual Enrollment :

15 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

The Role of Post-traumatic Inhibition of the Innate and Adaptive Immune System in the Development of Infectious Complications in Severely Injured Patients

Study Start Date :

Jun 1, 2014

Actual Primary Completion Date :

Jun 1, 2016

Actual Study Completion Date :

Jun 1, 2016

Outcome Measures

Primary Outcome Measures

Bactericidal capacity of neutrophils and sepsis [15 days following admission on ICU]
The correlation between reduced bactericidal capacity of neutrophils acquired from severely injured patients and the late occurrence of sepsis

Secondary Outcome Measures

Bactericidal capacity of neutrophils and infectious complications [15 days following admission to the ICU]
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)
Bactericidal capacity of neutrophils and pro-inflammatory complications [15 days following admission to the ICU]
The correlation between bactericidal function of neutrophils and the occurrence of pro-inflammatory complications (SIRS).
Priming capacity of neutrophils and infectious complications [15 days following admission on the ICU]
The relationship between the responsiveness of neutrophils to a priming stimulus (fMLP) and the occurrence of infectious complications
Complement system and infectious complications [15 days following admission to the ICU]
The correlation between functionality of the complement system and the occurence of infectious complications.
T-cell proliferation and infectious complications [15 days following admission on ICU]
The difference in suppression of T-cell proliferation in patients suffering infectious complications versus non-infectious patients.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)