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

NCT03489577 | Terminated

• 1 other identifier: 43279
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Inflammation; Multiple Organ Failure; Sepsis; Wounds and Injuries; Pathologic Processes; Shock; Infection; Systemic Inflammatory Response Syndrome; Neutrophils; PMN; Granulocytes; Innate immunity; ICU; Intensive Care; polytrauma; host-pathogen

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Bactericidal capacity of neutrophils and infectious complications

  15 days following admission to the ICU

• Bactericidal capacity of neutrophils and pro-inflammatory complications

  15 days following admission to the ICU

• Priming capacity of neutrophils and infectious complications

  15 days following admission on the ICU

• Complement system and infectious complications

  15 days following admission to the ICU

• T-cell proliferation and infectious complications

  15 days following admission on ICU

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Trauma patients likely to be admitted to the intensive care unit of the UMCU

You may qualify if:

• 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)

You may not qualify if:

• Immunosuppressive medication
• HIV and related diseases

Sponsors & Collaborators

• UMC Utrecht: lead

Study Sites (1)

University Medical Center Utrecht

Utrecht, 3508 GA, Netherlands

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood

MeSH Terms

Conditions

Multiple Trauma; Sepsis; Multiple Organ Failure; Inflammation; Wounds and Injuries; Pathologic Processes; Shock; Infections; Systemic Inflammatory Response Syndrome

Condition Hierarchy (Ancestors)

Pathological Conditions, Signs and Symptoms

Study Officials

• Pieter Leliefeld, Md

  UMC Utrecht

  PRINCIPAL INVESTIGATOR

• Luke PH Leenen, Prof. Dr.

  UMC Utrecht

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: March 29, 2018
• First Posted: April 5, 2018
• Study Start: June 1, 2014
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: April 5, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)