Multiple TraumaPOSEIDONNCT03489577
The Role of Post-traumatic Inhibition of the Innate and Adaptive Immune System in the Development of Infectious Complications in Severely Injured Patients
An observational study of Multiple Trauma and Sepsis, run by UMC Utrecht at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Multiple Trauma, Sepsis, Innate Immune Response
- How many people
- 15 participants
- Where
- 1 siteNetherlands
- Study dates
- Jun 2014to 1 Jun 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Trauma patients likely to be admitted to the intensive care unit of the UMCU
Who may be able to join
- 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)
Who cannot join
- Immunosuppressive medication
- HIV and related diseases
Trial locations and contacts
1 site in 1 country.
About this study
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
- Medical subject headings
- Multiple Trauma, Sepsis, Multiple Organ Failure, Inflammation, Wounds and Injuries, Pathologic Processes, Shock, Infections
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 15 days following admission on ICU
Secondary outcomes (5)
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)
Measured: 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).
Measured: 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
Measured: 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.
Measured: 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.
Measured: 15 days following admission on ICU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2018
- Study startJun 2014
- Primary completion1 Jun 2016
- Study completion1 Jun 2016
Why it stopped: Interim analysis provided enough data
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple TraumaStudies of the same condition, open and under way.
- More trials run by UMC UtrechtThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- UMC Utrecht
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. dr Leenen, UMC Utrecht
- Investigators
- Pieter Leliefeld, Md, Principal investigator, UMC UtrechtLuke PH Leenen, Prof. Dr., Study chair, UMC Utrecht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03489577
- Sponsor's protocol ID
- 43279
- Acronym
- POSEIDON
- Status last verified
- Mar 2018
- First submitted
- 29 Mar 2018
- Last updated
- 5 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03489577
- Acronym / sponsor ID
- POSEIDON / 43279
- 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
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Interim analysis provided enough data
- Enrolment
- 15 participants (actual)
- Lead sponsor
- UMC UtrechtUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- 1 Jun 2016 (actual)
- Study completion
- 1 Jun 2016 (actual)
- First posted
- 5 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Trauma patients likely to be admitted to the intensive care unit of the UMCU
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (2 listed)
- Immunosuppressive medication
- HIV and related diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Bactericidal capacity of neutrophils and sepsis
Time frame: 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
5 secondary outcomes
Bactericidal capacity of neutrophils and infectious complications
Time frame: 15 days following admission to the ICU
Bactericidal capacity of neutrophils and pro-inflammatory complications
Time frame: 15 days following admission to the ICU
Priming capacity of neutrophils and infectious complications
Time frame: 15 days following admission on the ICU
Complement system and infectious complications
Time frame: 15 days following admission to the ICU
T-cell proliferation and infectious complications
Time frame: 15 days following admission on ICU
Results and safety
The study was stopped early (reason given: Interim analysis provided enough data). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pieter Leliefeld, Md principal investigator
UMC Utrecht
Luke PH Leenen, Prof. Dr. study chair
UMC Utrecht
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Trauma and Sepsis, run by UMC Utrecht at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Interim analysis provided enough data). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bactericidal capacity of neutrophils and sepsis (time frame: 15 days following admission on ICU). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2018.