Fluid resuscitation is widely used in the management of critically ill patients. There are a variety of different fluids available to doctors but there is little evidence regarding how effective they are. One of the most commonly used fluids, a hydroxyethyl starch was recently approved by the TGA for use in Australia. This project aims to compare how effective and safe this fluid is compared to another widely used fluid, saline, for resuscitation of critically ill patients in intensive care.
Multi-centre Randomised Trial Of Early Decompressive Craniectomy In Patients With Severe Traumatic Brain Injury
Funder
National Health and Medical Research Council
Funding Amount
$490,500.00
Summary
Despite optimal neurosurgical and intensive care therapy, many trauma patients with severe brain injury (typically young males) have very poor long term neurological outcomes. Current knowledge suggests that a key contributor to secondary brain damage which occurs after injury and to poor neurological outcomes is brain swelling and subsequent increase in brain pressure. Present intensive care therapies to control brain pressure are often not effective, and favourable neurological outcomes occur ....Despite optimal neurosurgical and intensive care therapy, many trauma patients with severe brain injury (typically young males) have very poor long term neurological outcomes. Current knowledge suggests that a key contributor to secondary brain damage which occurs after injury and to poor neurological outcomes is brain swelling and subsequent increase in brain pressure. Present intensive care therapies to control brain pressure are often not effective, and favourable neurological outcomes occur in only 20-30% of these patients. Small studies suggest that a surgical operation called decompressive craniectomy (DC) may decrease brain pressure and improve neurological outcomes in these patients. DC involves temporarily surgically removing a piece of skull bone (during the swelling period) and replacing it when the swelling has subsided. DC is done under general anaesthetic in unconscious patients and is used occasionally at present, although due to insufficient research the benefits are controversial. The proposed study is a multi-centre randomised controlled study of best current therapies plus early decompressive craniectomy vs best current therapies alone in selected unconscious patients with severe head injury. The study outcome is patient neurological function measured 6 months after the injury. A study of this type is required before early DC could become a routine therapy in Australia. Next of kin will sign informed consent for the study and then also for the surgery if patients are randomised to surgery. The study will be managed at the Alfred Hospital-Monash University in Melbourne and includes fifteen collaborating ANZ neurotrauma centres over 3.0 years. There are >200 patients in Australia annually in this category with potential for DC to increase favourable outcomes in >40 patients annually. Lifetime costs for these patients with severe disability are > $2.4 million, so there may be substantial economic and social impact.Read moreRead less
A Phase II Randomised Controlled Trial Of Atorvastatin Therapy In Intensive Care Patients With Severe Sepsis
Funder
National Health and Medical Research Council
Funding Amount
$622,148.00
Summary
Infections are common in patients in the intensive care unit and produce inflammation that may spread throughout the body. Despite improved therapies, when infections cause failure of the body's vital organs, up to 40% of patients may die. The medication atorvastatin and other statins have been used for many years to treat and prevent conditions such as heart attack and stroke. They act primarily by reducing cholesterol production. In addition, they also modify inflammation and the immune system ....Infections are common in patients in the intensive care unit and produce inflammation that may spread throughout the body. Despite improved therapies, when infections cause failure of the body's vital organs, up to 40% of patients may die. The medication atorvastatin and other statins have been used for many years to treat and prevent conditions such as heart attack and stroke. They act primarily by reducing cholesterol production. In addition, they also modify inflammation and the immune system which may make them a useful treatment for patients with established infections. Although the statin drugs are usually safe, rare side effects may affect muscle and the liver. Because of concerns about increased risk of side effects it is currently recommended that statins should be stopped when patients become unwell. However, a number of studies have suggested that patients on statins for heart disease are less likely to develop infections and that their infections are less likely to be severe or result in death. Other studies have suggested that stopping statins in patients that present with infections (as suggested by current guidelines), may worsen infection outcomes. However, these studies have not been detailed enough to exclude all factors affecting outcome, such as patient age, severity of the infection, and the presence of other diseases. We plan to perform a study to assess the effect of atorvastatin on the outcome of infections in the intensive care unit. We will study 250 patients presenting with severe infections. We will randomly assign patients to receive either atorvastatin or placebo and monitor the effect on signs of inflammation and levels of life support. Outcomes and side effects will be carefully monitored. The study will help us decide whether to perform a larger study to determine if atorvastatin can reduce the risk of dying from serious infections.Read moreRead less
Hypertonic Saline (HTS) In Head Injured Patients - A Multicentre, Prehospital, Prospective Randomised Clinical Trial
Funder
National Health and Medical Research Council
Funding Amount
$247,269.00
Summary
Head injury is common in patients with major trauma, many of whom are young adults. The extent of head injury has a major influence on patient outcome. Low blood pressure after trauma worsens the extent of brain injury by decreasing its blood supply at a critical stage. Much of this secondary brain injury occurs before the patient reaches hospital. Hypertonic saline (HTS) is an intravenous salt solution which has been used in intensive care patients for many years to decrease brain swelling in h ....Head injury is common in patients with major trauma, many of whom are young adults. The extent of head injury has a major influence on patient outcome. Low blood pressure after trauma worsens the extent of brain injury by decreasing its blood supply at a critical stage. Much of this secondary brain injury occurs before the patient reaches hospital. Hypertonic saline (HTS) is an intravenous salt solution which has been used in intensive care patients for many years to decrease brain swelling in head injured patients. We know that HTS can be given to patients before they reach hospital, is safe, and acts by rapidly increasing blood pressure and decreasing brain swelling. Accordingly HTS may minimise secondary brain injury and lead to increased survival. Importantly, HTS is likely to dramatically improve neurological function of survivors without any significant risk of side effects. This study is designed to determine the effectiveness of prehospital HTS in head injured trauma patients with traumatic coma and low blood pressure.Read moreRead less
Early Parenteral Nutrition Vs. Standard Care In The Critically Ill Patient: A Level I Randomised Controlled Trial.
Funder
National Health and Medical Research Council
Funding Amount
$1,852,333.00
Summary
Nutritional support is accepted as a standard of care for the hospitalised patient however there is little agreement as to how it should be provided to the critically ill patient. Despite the fact that studies consistently link malnutrition to worse outcomes, the provision of nutritional support to the critically ill patient is highly variable. Although there is general agreement that it is best to feed critically ill patients via the gastrointestinal tract (stomach tube feeding), there is no ge ....Nutritional support is accepted as a standard of care for the hospitalised patient however there is little agreement as to how it should be provided to the critically ill patient. Despite the fact that studies consistently link malnutrition to worse outcomes, the provision of nutritional support to the critically ill patient is highly variable. Although there is general agreement that it is best to feed critically ill patients via the gastrointestinal tract (stomach tube feeding), there is no general agreement as to when intravenous artificial nutrition should be begun if a patient cannot tolerate a feeding tube. A recent systematic review of all available clinical trials suggests that if a critically ill patient cannot be fed by a stomach tube for at least 24 hours, they may benefit from intravenous artificial nutrition. This is not what currently happens under standard care. The purpose of this multi-centre randomised controlled trial is to determine if early intravenous nutrition saves lives. Because of the cost, and possible risk of increased infections, a study of this type is required before early intravenous nutrition could become a routine therapy in Australia. Informed consent to participate in the study will be obtained from next of kin, or directly from the patient themselves. The study will be managed at the Royal North Shore Hospital, University of Sydney and will include 26 collaborating ANZ hospitals over 18 months.Read moreRead less