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

Sepsis Clinical Trial

— POSEIDON  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03489577
• Other study ID #: 43279
• Status: Terminated
• 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
• 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

Related Conditions & MeSH terms

• Disorder of Neutrophils
• Innate Immune Response
• Multiple Organ Dysfunction Syndrome
• Multiple Organ Failure
• Multiple Trauma
• Sepsis

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