The Predictive Value of Clinical and Immunological Factors in the Development of Pneumonia After Traumatic Brain Injury

NCT00929448 | Completed

• 1 other identifier: iTBI2009
• Study Type: observational
• Target: 110
• Locations: 1 country
• Sites: 1

Brief 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. 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

Outcome Measures

Primary Outcomes (1)

• The primary outcome of this study will be the development of the composite of either early onset pneumonia (EOP) or ventilator associated pneumonia (VAP

  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.

  hospital discharge

Study Arms (1)

Immunoglobulin

Eligibility Criteria

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

Study Population

Intensive Care

You may qualify if:

• \> 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

You may not qualify if:

• Longer than 5 days since ictus of TBI

Sponsors & Collaborators

• Royal Alexandra Hospital: lead

Study Sites (1)

Royal Alexandra Hospital

Edmonton, Alberta, T5H3V9, Canada

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Demetrios Kutsogiannis, MD

  Royal Alexandra Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, MHS, FRCPC

Study Record Dates

• First Submitted: June 26, 2009
• First Posted: June 29, 2009
• Study Start: July 1, 2008
• Primary Completion: February 1, 2010
• Study Completion: February 1, 2010
• Last Updated: December 4, 2012

Record last verified: 2012-12

Locations

CA (1)