Clinical trials
The Royal Brisbane and Women's Hospital Departments of Intensive Care Medicine, and Trauma Medicine together with the BTCCRC are site investigators for the following single and multi-centre trials.
Current
ADRENAL: A randomised controlled trial of the effect of hydrocortisone on mortality in critically ill patients with septic shock. Principal Site Investigator: J Cohen
ASAP-ECMO (Extracorporeal Membrane Oxygenation): A multi-centre Australian pharmacokinetic study evaluating the pharmacokinetics of various antibiotics, antifungals, sedatives and analgesics in critically ill patients receiving extracorporeal membrane oxygenation. Principal Site Investigator: J Roberts
DahLIA: A randomised, double-blind, placebo controlled trial of dexmedetomidine for patients with agitation and delirium in the ICU. Principal Site Investigator: M Reade
RSVP: A Multi-centred trial to examine implications of a routine versus clinically indicated need to change giving sets for iv infusions. Principal Site Investigator: J Gowardman
MicroSOAP: Microcirculatory Shock Occurrence in Acutely ill Patients-microcirculatory alterations in ICU patients with tachycardia are associated with a substantially increased risk of in-hospital death. Principal Site Investigator: A Holley
TRANSFUSE: STandaRd Issue TrANsfusion versuS Fresher red blood cell Use in intenSive care. A multi-centre randomised double blinded phase III trial of the effect of standard issue red blood cell blood units on mortality compared to freshest available red blood cell units. Principal Investigator: M Reade. Principal Site Investigator: A Holley
BLING III: A phase III randomised controlled trial of continuous beta-lactam infusion compared with intermittent beta-lactam dosing in critically ill patients. Principal Site Investigator: J Lipman
Ceftriaxone in Pneumonia: Optimising ceftriaxone dosing for critically ill patients with severe pneumonia. Principal Investigators: M Cotta, J Roberts
Ceftolozane/Tazobactam RRT: An observational pharmacokinetic study of Ceftolozane-Tazobactam in Intensive Care Unit in patients with and without continuous renal replacement therapy. Principal Site Investigator: J Roberts
Ceftolozane/Tazobactam EVD: A prospective observational pharmacokinetic evaluation of the plasma and cerebrospinal fluid concentrations of a single dose ceftolozane/tazobactam in infected critically ill patients with an indwelling external ventricular drain. Principal Site Investigators: J Roberts, J Lipman
Colonic Flora: Assessing the effects of antibiotic choice on gut microbiota of ICU patients - a metagenomic approach. Principal Site Investigators: D Paterson, P Harris, S Schlebusch
GUPPIE: An Observational Study to assess aspiration risk using gastric ultrasound in ventilated ICU patients prior to extubation Principal Site Investigators: S O'Donoghue, E Roach
LEVETY: Levetiracetam pharmacokinetics in critically ill patients with severe traumatic brain injury and subarachnoid haemorrhage. Principal Site Investigators: M Cotta, J Roberts
Microsampling: Validation of microsampling versus traditional blood sampling for antibiotic pharmacokinetics. Principal Site Investigators: J Lipman, S Wallis
OASES: The Pharmacokinetics of Ceftriaxone, Meropenem, Piperacillin-Tazobactam and Vancomycin in the Cerebrospinal Fluid of Critically Ill Patients with Uninflamed Meninges. Principal Site Investigators: J Roberts, N Kumta
PATCH TRAUMA: Pre-hospital Anti-fibrinolytics for Traumatic Coagulopathy and Haemorrhage (The PATCH Study). A multi-centre randomised, double-blind, placebo-controlled trial of pre-hospital treatment with tranexamic acid for severely injured patients at risk of acute traumatic coagulopathy. Principal Site Investigators: M Reade, A Holley
PLUS: A multi-centre, blinded, randomised, controlled trial to determine whether fluid resuscitation and therapy with a “balanced” crystalloid solution (Plasma-Lyte 148®) decreases 90-day mortality in critically ill patients requiring fluid resuscitation when compared to the same treatment with 0.9% sodium chloride (saline). Principal Site Investigator: J Lipman
RESIST: Recognising Sepsis in SIRS Trial. Principal Site Investigator: K Denny
TBI Study: A Comparison of the Total and Free Cortisol Response to a Standard Short Synacthen Test in Patients with Traumatic Brain Injury. Principal Investigator: J Cohen
Synacthen Study: The free cortisol response to synacthen and other aspects of endocrine physiology in healthy participants. Principal Site Investigators: J Cohen, G Nethathe
Nicotine study: Pharmacokinetics of Transdermal Nicotine replacement therapy patches in the ICU: A prospective observational pharmacokinetic study of nicotine/cotinine concentrations in critically ill smokers receiving transdermal NRT patches. Principal Site Investigators: J Cohen, D Lui
ADRENAL: A randomised controlled trial of the effect of hydrocortisone on mortality in critically ill patients with septic shock. Principal Site Investigator: J Cohen
ASAP-ECMO (Extracorporeal Membrane Oxygenation): A multi-centre Australian pharmacokinetic study evaluating the pharmacokinetics of various antibiotics, antifungals, sedatives and analgesics in critically ill patients receiving extracorporeal membrane oxygenation. Principal Site Investigator: J Roberts
DahLIA: A randomised, double-blind, placebo controlled trial of dexmedetomidine for patients with agitation and delirium in the ICU. Principal Site Investigator: M Reade
RSVP: A Multi-centred trial to examine implications of a routine versus clinically indicated need to change giving sets for iv infusions. Principal Site Investigator: J Gowardman
MicroSOAP: Microcirculatory Shock Occurrence in Acutely ill Patients-microcirculatory alterations in ICU patients with tachycardia are associated with a substantially increased risk of in-hospital death. Principal Site Investigator: A Holley
TRANSFUSE: STandaRd Issue TrANsfusion versuS Fresher red blood cell Use in intenSive care. A multi-centre randomised double blinded phase III trial of the effect of standard issue red blood cell blood units on mortality compared to freshest available red blood cell units. Principal Investigator: M Reade. Principal Site Investigator: A Holley
BLING III: A phase III randomised controlled trial of continuous beta-lactam infusion compared with intermittent beta-lactam dosing in critically ill patients. Principal Site Investigator: J Lipman
Ceftriaxone in Pneumonia: Optimising ceftriaxone dosing for critically ill patients with severe pneumonia. Principal Investigators: M Cotta, J Roberts
Ceftolozane/Tazobactam RRT: An observational pharmacokinetic study of Ceftolozane-Tazobactam in Intensive Care Unit in patients with and without continuous renal replacement therapy. Principal Site Investigator: J Roberts
Ceftolozane/Tazobactam EVD: A prospective observational pharmacokinetic evaluation of the plasma and cerebrospinal fluid concentrations of a single dose ceftolozane/tazobactam in infected critically ill patients with an indwelling external ventricular drain. Principal Site Investigators: J Roberts, J Lipman
Colonic Flora: Assessing the effects of antibiotic choice on gut microbiota of ICU patients - a metagenomic approach. Principal Site Investigators: D Paterson, P Harris, S Schlebusch
GUPPIE: An Observational Study to assess aspiration risk using gastric ultrasound in ventilated ICU patients prior to extubation Principal Site Investigators: S O'Donoghue, E Roach
LEVETY: Levetiracetam pharmacokinetics in critically ill patients with severe traumatic brain injury and subarachnoid haemorrhage. Principal Site Investigators: M Cotta, J Roberts
Microsampling: Validation of microsampling versus traditional blood sampling for antibiotic pharmacokinetics. Principal Site Investigators: J Lipman, S Wallis
OASES: The Pharmacokinetics of Ceftriaxone, Meropenem, Piperacillin-Tazobactam and Vancomycin in the Cerebrospinal Fluid of Critically Ill Patients with Uninflamed Meninges. Principal Site Investigators: J Roberts, N Kumta
PATCH TRAUMA: Pre-hospital Anti-fibrinolytics for Traumatic Coagulopathy and Haemorrhage (The PATCH Study). A multi-centre randomised, double-blind, placebo-controlled trial of pre-hospital treatment with tranexamic acid for severely injured patients at risk of acute traumatic coagulopathy. Principal Site Investigators: M Reade, A Holley
PLUS: A multi-centre, blinded, randomised, controlled trial to determine whether fluid resuscitation and therapy with a “balanced” crystalloid solution (Plasma-Lyte 148®) decreases 90-day mortality in critically ill patients requiring fluid resuscitation when compared to the same treatment with 0.9% sodium chloride (saline). Principal Site Investigator: J Lipman
RESIST: Recognising Sepsis in SIRS Trial. Principal Site Investigator: K Denny
TBI Study: A Comparison of the Total and Free Cortisol Response to a Standard Short Synacthen Test in Patients with Traumatic Brain Injury. Principal Investigator: J Cohen
Synacthen Study: The free cortisol response to synacthen and other aspects of endocrine physiology in healthy participants. Principal Site Investigators: J Cohen, G Nethathe
Nicotine study: Pharmacokinetics of Transdermal Nicotine replacement therapy patches in the ICU: A prospective observational pharmacokinetic study of nicotine/cotinine concentrations in critically ill smokers receiving transdermal NRT patches. Principal Site Investigators: J Cohen, D Lui
Completed
DALI: Defining Antibiotic Levels in Intensive care unit patients. Principal Site Investigators: J Lipman, J Roberts, S Wallis DALI: Interview with Jason Roberts and Jeffrey Lipman
ATHLOMICS: Continuous Monitoring of Acute Non-Specific Immuno-inflammatory Response using SeptiCyte®Lab to Determine the Relationship Between Inflammatory Index and Clinical Progression and Outcome Measures. Principal Site Investigator: J Lipman
CHEST: A multi-centre randomised controlled trial of fluid resuscitation with starch (6% hydroxyethyl starch 130/0.4) compared to saline (0.9% sodium chloride) in intensive care patients on mortality. Principal Site Investigator: J Lipman
ARCTIC: Augmented Renal Clearance in The Intensive Care. Principal Site Investigator: A Udy
ARCTICUS: Augmented Renal Clearance in The Intensive Care Unit: Multi-centre trial with Singapore. Principal Site Investigator: A Udy
CYTOFAB TNF alpha antagonist: A Multicentre, Randomised, Double-Blind, Placebo‑controlled Phase IIb Study to compare the Efficacy and Safety of Two Dosing Regimens of Intravenous Infusions of CytoFab™ (AZD9773) in Adult Patients With Severe Sepsis and/or Septic Shock. Principal Investigator: S O'Donoghue
RENAL: A Pharmacokinetic Substudy identifying the variability in trough antibiotic concentrations and the influence of effluent flow rates on dosing requirements for critically ill patients. Principal Investigator: J Lipman
DUST: Distal Ureteric Stone Tamsulosin: A double-blinded, placebo-controlled, randomised trial. Principal Investigators: J Furyk, K Chu
CLIP (Cryopreserved vs LIquid Platelet study): Evaluation of cryopreserved platelets for the treatment of perioperative haemorrhage. Principal Investigator: M Reade
SMARRT (SaMpling Antibiotics in Renal Replacement Therapy): Evidence-based antibiotic dosing for critically ill patients receiving renal replacement therapy. Principal Investigator: J Roberts
ANZ Clinical Trials Registration
Post RENAL: Prolonged outcome study of patients admitted to ICU who received Continuos Renal replacement therapy for Acute renal failure. Principal Investigator: J Lipman
ARISE (Australian Resuscitation In Sepsis Evaluation): A randomised controlled trial comparing early goal directed therapy to standard care for patients in septic shock. Principal Site Investigator: J Williams
IPHIVAP: Inhaled Prophylactic Heparin in Ventilator Associated Pneumonia. Principal Investigator: R Boots
BLING II: A national and international Phase IIb clinical trial of continuous β-lactam infusion compared with intermittent β-lactam dosing in critically ill patients with severe sepsis. Principal Investigator: J Lipman
DALI: Defining Antibiotic Levels in Intensive care unit patients. Principal Site Investigators: J Lipman, J Roberts, S Wallis DALI: Interview with Jason Roberts and Jeffrey Lipman
ATHLOMICS: Continuous Monitoring of Acute Non-Specific Immuno-inflammatory Response using SeptiCyte®Lab to Determine the Relationship Between Inflammatory Index and Clinical Progression and Outcome Measures. Principal Site Investigator: J Lipman
CHEST: A multi-centre randomised controlled trial of fluid resuscitation with starch (6% hydroxyethyl starch 130/0.4) compared to saline (0.9% sodium chloride) in intensive care patients on mortality. Principal Site Investigator: J Lipman
ARCTIC: Augmented Renal Clearance in The Intensive Care. Principal Site Investigator: A Udy
ARCTICUS: Augmented Renal Clearance in The Intensive Care Unit: Multi-centre trial with Singapore. Principal Site Investigator: A Udy
CYTOFAB TNF alpha antagonist: A Multicentre, Randomised, Double-Blind, Placebo‑controlled Phase IIb Study to compare the Efficacy and Safety of Two Dosing Regimens of Intravenous Infusions of CytoFab™ (AZD9773) in Adult Patients With Severe Sepsis and/or Septic Shock. Principal Investigator: S O'Donoghue
RENAL: A Pharmacokinetic Substudy identifying the variability in trough antibiotic concentrations and the influence of effluent flow rates on dosing requirements for critically ill patients. Principal Investigator: J Lipman
DUST: Distal Ureteric Stone Tamsulosin: A double-blinded, placebo-controlled, randomised trial. Principal Investigators: J Furyk, K Chu
CLIP (Cryopreserved vs LIquid Platelet study): Evaluation of cryopreserved platelets for the treatment of perioperative haemorrhage. Principal Investigator: M Reade
SMARRT (SaMpling Antibiotics in Renal Replacement Therapy): Evidence-based antibiotic dosing for critically ill patients receiving renal replacement therapy. Principal Investigator: J Roberts
ANZ Clinical Trials Registration
Post RENAL: Prolonged outcome study of patients admitted to ICU who received Continuos Renal replacement therapy for Acute renal failure. Principal Investigator: J Lipman
ARISE (Australian Resuscitation In Sepsis Evaluation): A randomised controlled trial comparing early goal directed therapy to standard care for patients in septic shock. Principal Site Investigator: J Williams
IPHIVAP: Inhaled Prophylactic Heparin in Ventilator Associated Pneumonia. Principal Investigator: R Boots
BLING II: A national and international Phase IIb clinical trial of continuous β-lactam infusion compared with intermittent β-lactam dosing in critically ill patients with severe sepsis. Principal Investigator: J Lipman