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Anterior Pituitary Dysfunction in Severe TBI

ICU Research

In this study, 100 patients with severe Traumatic Brain Injury were tested for hypothalamic-pituitary dysfunction at 4 time points after injury. This is the first prospective study to address this question. We found that more than 90% of patients had abnormal hypothalamic-pituitary function tests in the first weeks after brain injury and that many patients recovered spontaneously and did not require treatment.
However 30% of patients had persistent deficiencies 12 months after injury. One third of these patients had secondary testosterone or estrogen deficiency which can be treated. One third had growth hormone deficiency, and whether GH replacement therapy is appropriate in this population is not yet established. Persistent cortisol deficiency was only identified in 3 patients and 2 of these were identified in the first week after TBI.
Some of the patients are likely to have sub-clinical cortisol deficiency which may only manifest during future stress or illness. Accordingly patients with deficiencies will be followed annually to ensure that those with deteriorating hypothalamic-pituitary function over time will be identified and appropriately managed.

Decompressive Craniectomy (DECRA) study

ICU Research

Despite the best Intensive Care and Neurosurgery therapies, many patients with Traumatic Brain Injuries have poor long term outcomes. A key contributor to the poor outcomes is increased brain pressure from brain swelling. Current therapies are not always effective to control brain pressures and in these situations favourable outcomes are less common.

We are studying a surgical operation called Decompressive Craniectomy to decrease brain pressures and improve patient outcomes. This involves temporarily removing a piece of skull bone to enable the pressures to decrease during the swelling phase and replacing it when the swelling has subsided. This is done under general anaesthetic in unconscious patients, but the overall benefits are currently uncertain.

A pilot study of early Decompressive Craniectomy has been completed at The Alfred hospital and currently a large Multicentre randomised controlled study of early Decompressive Craniectomy has been commenced at 16 sites throughout Australia and New Zealand. This study will comprise 210 patients over 3 years and will determine whether the early use of this surgery improves neurological function in patients when measured 6 months after the injury. This study is the first of its kind in adults and is required before early Decompressive Craniectomy could become a routine therapy for all appropriate patients. 41 patients were enrolled in the study in February 2005.

Explicit & Implicit Memory Functioning in PTSD: An Event Related Potential Investigation

Psychological Research

This DPsych project is being conducted by Kim Roffel in collaboration with the University of Melbourne and NTRI. The aim of this project is to investigate the nature of memory functioning in posttraumatic stress disorder (PTSD). Specifically, implicit and explicit memory will be assessed in individuals who have experienced a motor vehicle accident and who have developed PTSD. Individuals who have experienced a motor vehicle accident who have not developed PTSD will act as a control group. Participants will be presented with a random assortment of pleasant, unpleasant, neutral, and traumatic pictures and will be asked to remember them for later recognition tasks. During the learning and recognition phases of this task, the brain’s electrical activity will be recorded with an encephalogram (EEG). A total of 30 participants are required for this study, which commenced in August 2005.

Lung Open Ventilation (LOVS) Study

ICU Research

Mechanical ventilation causes lung damage, a phenomenon known as ventilator induced lung injury (VILI). Critically ill patients with acute lung injury (ALI) are at particularly high risk for ventilator associated lung injury, the clinical equivalent of VILI, and its associated increase in mortality.

This trial is an international (Canada & Australia) multi-centre randomised controlled trial (RCT) among patients with ALI comparing two different ventilation strategies - a lung open ventilation strategy (LOVS) and a pressure and volume-limited ventilation strategy (PVLV) - with respect to morbidity and mortality. The goal of LOVS is to provide respiratory support that will promote lung healing rather than perpetuate lung injury.

Prophylaxis for Thromboembolism in Critical Care Trial - PROTECT Study

ICU Research

Critically ill patients have an increased risk of deep venous thrombosis (DVT) due to their acute illness, some procedures and immobility due to sedation and paralysis. Among patients in the ICU, DVT is an important problem which can lead to potentially fatal pulmonary embolism (PE). Research to establish the safest and most efficacious means of DVT prophylaxis is required.

The PROTECT study is a multi-centre clinical trial in Australia and Canada. The scientific objectives of the PROTECT study are to determine the effect of Low Molecular Weight Heparin (LMWH) versus Unfractionated Heparin (UHF) on rates of DVT, PE, bleeding, thrombocytopenia and heparin induced thrombocytopenia in medical-surgical patients in ICU.

The pilot study has been successfully completed and applications for funding the main study have been submitted in Australia and Canada.

Psychopathology Following Injury: Screening for Vulnerability

Psychological Research

This study is a collaboration between the Australian Centre for Posttraumatic Mental Health (ACPMH) at the University of Melbourne, the NTRI, the Departments of Psychiatry and Trauma at the Alfred, and the Departments of Psychiatry and Trauma at Royal Melbourne Hospital.

The project “Psychopathology Following Injury: Screening for Vulnerability” funded by the Victoria Trauma Foundation commenced in April 2004 at the trauma services of the Alfred and Royal Melbourne Hospitals. The aim of this study is to develop and validate a screening instrument that will identify in the acute hospital setting, individuals who are vulnerable to developing mental health problems such as posttraumatic stress disorder and depression following injury. Random admissions to the trauma service of each hospital are assessed in the acute hospital setting, and at 3 and 12 months post injury. We are in the fortunate position to have been able to add our protocol to the Risk and Resilience study (described below) which has resulted in an additional three hospitals (in Sydney and Adelaide) collecting ‘Screening Study’ data. Our aim to recruit over 500 participants to the study was met in May and we are very happy with our follow-up rates. Phase one of the project (identifying the best predictors from an item pool ) will end in May 2005, and we aim to complete phase 2 (trialling the developed screening instrument) in July 2006.

Randomised trial of Vasopressin versus Noradrenaline in septic shock - VASST Study

ICU Research

Patients with severe infection (sepsis) often have problems maintaining their blood pressure; this is called "Septic Shock". The low blood pressure associated with septic shock may be treated with a drug called Noradrenaline. However sometimes the Noradrenaline does not work effectively enough and very high doses might be needed.

Safe and effective alternative treatments are being investigated. Studies have shown that during septic shock the levels of a natural hormone called vasopressin are reduced. Vasopressin is essential for autoregulation of blood pressure.

This study is a multi-centre randomised controlled trial to establish whether the addition of low dose vasopressin to standard treatment will produce better patient outcome.

Risk and Resilience following Injury

Psychological Research

This study is a collaboration between the Australian Centre for Posttraumatic Mental Health at the University of Melbourne, the NTRI, and the Universities of New South Wales and Adelaide.

This NHMRC funded study is being project managed by Dr Meaghan O’Donnell (NTRI). This national study is being conducted in five trauma services in Australia and represents one of the largest studies of its kind to occur both nationally and internationally. The aim of the study is to identify both risk and resilience factors that mediate and moderate mental health outcomes following traumatic injury. This study is longitudinal in design with assessments conducted just prior to discharge from the acute setting, and at 3, 12 and 24 months. Participant recruitment commenced mid 2004 and will be completed around July 2006. Both the trauma services at the Alfred and Royal Melbourne Hospitals are involved in this study. Currently recruitment statistics are consistent with those in the ‘Screening Study’ described above.

Role of Cognitive Emotional Regulation in Adjustment Following Traumatic Injury

Psychological Research

This PhD project is being conducted by Bronwyn Jones in collaboration with the ACPMH, University of Melbourne and NTRI. The aim of the project is to identify the emotional regulatory strategies employed by injury survivors that both assist or interfere with adjustment following this traumatic event. Emotional regulation strategies are those that are utilised to promote or inhibit the emotions that are particularly intense following a traumatic event. This project aims to statistically model the role these cognitive emotional strategies play process in the adjustment. The outcomes from this project will have direct applications for therapeutic intervention techniques. The study commenced in May 2005.

SAFE TBI sub study

ICU Research

The landmark SAFE study (the largest randomised controlled trial ever to be conducted within Intensive Care Units) suggested a difference in 28 day mortality in Traumatic Brain Injury patients receiving intravenous volume replacement with albumin compared to those receiving saline. Accordingly a post hoc analysis of outcomes in patients with Traumatic Brain Injury is being conducted. This sub study is known as SAFE TBI.
The principal aims of SAFE TBI are to determine baseline equivalence in the two groups by quantifying severity of injury. Twenty eight day mortality as used in the main SAFE study is not an accepted or appropriate endpoint for patients with Traumatic Brain Injury as outcome changes over time in this group. Hence this study aims to gather information using a standardised tool that is internationally recognised for measuring outcome from Traumatic Brain Injury. Telephone interviews with patients and their families are being performed at 2 years post injury to assess functional neurological status using the extended Glasgow Outcome Score questionnaire.
SAFE TBI is currently in the phase of data collection with more than half the neurological assessments already completed.

TBI Intensive Monitoring

Trauma Surgery research

The TBI Intensive Monitoring study aims to introduce complementary focal and global monitoring techniques which will permit the development of more individualised and 'targeted' therapy for the patient with severe head injury, reduce episodes of secondary brain injury and therefore improve outcomes. These include brain metabolite monitoring using microdialysis, brain tissue oxygen and jugular venous saturation monitoring, cerebral autoregulation monitoring using transcranial doppler and the pressure reactivity index (PRx), Cerebral blood flow monitoring using perfusion CT and brain temperature monitoring and intravascular temperature control using the 'Innercool' system. The study has now progressed from an initial observational phase consisting of 10 patients to an interventional phase, which involves the introduction of evidence-based treatment protocols.

Clinical Research

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