Traumatic Brain InjuryNCT00929448
The Predictive Value of Clinical and Immunological Factors in the Development of Pneumonia After Traumatic Brain Injury
An observational study of Traumatic Brain Injury, run by Royal Alexandra Hospital at 1 site in Canada.
Trial summary
The development of pneumonia and other infections is one of the most common complications of a traumatic brain injury (TBI). Prior studies have also found that patients suffering from TBI also develop immune dysfunction consistent with an immunosuppressed state shortly after the traumatic event. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Traumatic Brain Injury
- How many people
- 110 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2008to Feb 2010
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Intensive Care
Who may be able to join
- > 18 yrs
- Admitted to ICU in Capital Health region with a TBI and > 1 of the following:
- An initial resuscitated (Sys BP>90 mmHg and O2 Sat >90%) GSC of ≤ 8
- A post resuscitation (Sys BP>90 mmHg and O2 Sat >90%) GCS at presentation to the hospital of ≤ 8 in the absence of sedation
- A post resuscitation (Sys BP>90 mmHg and O2 Sat >90%) GCS within 72 hrs of hospital admission of ≤ 8 in the absence of sedation
- Intracranial pressure monitoring
- Decompressive craniectomy
- Presence of subfalcine, uncal, or supratentorial herniation either clinically or radiologically
Who cannot join
- Longer than 5 days since ictus of TBI
Trial locations and contacts
1 site in 1 country.
About this study
The development of pneumonia and other infections is one of the most common complications of a traumatic brain injury (TBI). Prior studies have also found that patients suffering from TBI also develop immune dysfunction consistent with an immunosuppressed state shortly after the traumatic event. Specifically, it has been shown that patients with a TBI have impaired delayed type hypersensitivity (DTH), cellular immunity and humoral immunity. The humoral arm of the immune system is particularly involved in defending the host against extracellular bacteria and is primarily composed of B-cells, immunoglobulins and complement. Surgery and trauma impair the clonal expansion of antibody producing B lymphocytes causing hypogammaglobulinemia, through a mechanism involving T lymphocytes. In addition, during the systemic inflammatory process, pro-inflammatory cytokines such as tumor necrosis factor alpha (TNF-alpha), interleukin 1 (IL-1beta) and interleukin 6 (IL-6) are released. Nuclear factor kappa beta (NF-kB) is a transcriptional regulatory protein that is involved in the expression of proinflammatory cytokines and appears to act at a critical step in the transcription of many proinflammatory genes.
The hypothesis of this study is that the hypogammaglobulinemia from the immune dysfunction and the induction of NF-kB from the inflammatory process are, in part, responsible for the development of pneumonia and other infectious complications identified after TBI. This study has two specific aims: The primary specific aim of this study is to determine the association between serum immunoglobulin or NF-kB levels and the development of pneumonia in patients suffering from traumatic brain injury (TBI). The secondary specific aim of this study is to determine the relative contribution of clinical variables such as APACHE II-III Score and Injury Severity Score as compared to immunological variables (serum immunoglobulins and NF-kB) to the development of pneumonia in patients suffering from TBI.
- Conditions
- Traumatic Brain Injury
- Keywords
- Traumatic brain injury
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Immunoglobulin | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome of this study will be the development of the composite of either early onset pneumonia (EOP) or ventilator associated pneumonia (VAP
Measured: baseline, d4, d7, d10, d14
Secondary outcomes (1)
Secondary outcomes will include ICU and hospital mortality and LOS, duration of mechanical ventilation, Glasgow Outcome Score (GOS) at hospital discharge and at 6-months, and 1-year.
Measured: hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2009 (estimated)
- Study startJul 2008
- Primary completionFeb 2010
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- 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
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royal Alexandra Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Demetrios J. Kutsogiannis, Royal Alexandra Hospital
- Investigators
- Demetrios Kutsogiannis, MD, Principal investigator, Royal Alexandra Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00929448
- Sponsor's protocol ID
- iTBI2009
- Status last verified
- Dec 2012
- First submitted
- 26 Jun 2009
- Last updated
- 4 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Predictive Value of Clinical and Immunological Factors in the Development of Pneumonia After Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT00929448
- Acronym / sponsor ID
- iTBI2009
- Conditions
- Traumatic Brain Injury
- Keywords
- Traumatic brain injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Royal Alexandra HospitalUniversity, hospital or other
- Study start
- Jul 2008
- Primary completion
- Feb 2010 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 29 Jun 2009 (estimated)
- 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.
The development of pneumonia and other infections is one of the most common complications of a traumatic brain injury (TBI). Prior studies have also found that patients suffering from TBI also develop immune dysfunction consistent with an immunosuppressed state shortly after the traumatic event. Specifically, it has been shown that patients with a TBI have impaired delayed type hypersensitivity (DTH), cellular immunity and humoral immunity. The humoral arm of the immune system is particularly involved in defending the host against extracellular bacteria and is primarily composed of B-cells, immunoglobulins and complement. Surgery and trauma impair the clonal expansion of antibody producing B lymphocytes causing hypogammaglobulinemia, through a mechanism involving T lymphocytes. In addition, during the systemic inflammatory process, pro-inflammatory cytokines such as tumor necrosis factor alpha (TNF-alpha), interleukin 1 (IL-1beta) and interleukin 6 (IL-6) are released. Nuclear factor kappa beta (NF-kB) is a transcriptional regulatory protein that is involved in the expression of proinflammatory cytokines and appears to act at a critical step in the transcription of many proinflammatory genes.
The hypothesis of this study is that the hypogammaglobulinemia from the immune dysfunction and the induction of NF-kB from the inflammatory process are, in part, responsible for the development of pneumonia and other infectious complications identified after TBI. This study has two specific aims: The primary specific aim of this study is to determine the association between serum immunoglobulin or NF-kB levels and the development of pneumonia in patients suffering from traumatic brain injury (TBI). The secondary specific aim of this study is to determine the relative contribution of clinical variables such as APACHE II-III Score and Injury Severity Score as compared to immunological variables (serum immunoglobulins and NF-kB) to the development of pneumonia in patients suffering from TBI.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Immunoglobulin | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Intensive Care
Key inclusion criteria (8 listed)
- > 18 yrs
- Admitted to ICU in Capital Health region with a TBI and > 1 of the following:
- An initial resuscitated (Sys BP>90 mmHg and O2 Sat >90%) GSC of ≤ 8
- A post resuscitation (Sys BP>90 mmHg and O2 Sat >90%) GCS at presentation to the hospital of ≤ 8 in the absence of sedation
- A post resuscitation (Sys BP>90 mmHg and O2 Sat >90%) GCS within 72 hrs of hospital admission of ≤ 8 in the absence of sedation
Key exclusion criteria (1 listed)
- Longer than 5 days since ictus of TBI
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
The primary outcome of this study will be the development of the composite of either early onset pneumonia (EOP) or ventilator associated pneumonia (VAP
Time frame: baseline, d4, d7, d10, d14
1 secondary outcome
Secondary outcomes will include ICU and hospital mortality and LOS, duration of mechanical ventilation, Glasgow Outcome Score (GOS) at hospital discharge and at 6-months, and 1-year.
Time frame: hospital discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2012.
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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.
Demetrios Kutsogiannis, MD principal investigator
Royal Alexandra Hospital
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 Traumatic Brain Injury, run by Royal Alexandra Hospital at 1 site in Canada.
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 8 inclusion and 1 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: finished, as of the sponsor's last update on 4 Dec 2012. 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 Canada. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The primary outcome of this study will be the development of the composite of either early onset pneumonia (EOP) or ventilator associated pneumonia (VAP (time frame: baseline, d4, d7, d10, d14). 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 4 Dec 2012.