Surgery Research

Professor Yahya Shehabi leads the research team and activities.

A/Prof David Earnest with a patient

ICU studies - Clayton

SCARLET STUDY: (ART-123 Study): A Randomised, Double-Blind, Placebo-Controlled, Phase 3 study to assess the Safety and Efficacy of ART-123 in Subjects with Severe Sepsis and Coagulopathy.
Principal Investigator: A/Prof David Ernest

VITAL Study: A Phase 3 Randomised Double-Blind Study Comparing TR701 FA and Linezolid in Ventilated Gram Positive Nosocomial Pneumonia.
Principal Investigator: A/Prof David Ernest

INHALE 1 Study: A Prospective, Randomized, Double-Blind, Placebo-Controlled, Multicentre Study to Evaluate the Safety and Efficacy of BAY 41-6551 as Adjunctive Therapy in Intubated and Mechanically-Ventilated Patients with Gram-Negative Pneumonia.
Principal Investigator: A/Prof David Ernest

TRANSFUSE Study: Standard issue transfusion versus fresher blood cell in Intensive Care, a randomised controlled trial.
Principal Investigator: A/Prof David Ernest

Adrenal Study: A Randomised blinded placebo controlled trial of hydrocortisone in critically ill patients with Septic Shock.
Principal Investigator: Dr Tim Crozier

SPICE Study: Early goal-directed sedation compared with standard care in mechanically ventilated critically ill patients: a prospective multicentre randomised controlled trial.
Principal Investigator: Dr Paul Ritchie

Nebulised Heparin: Nebulised Heparin for Lung Injury. A Multi-centre, randomised, double –blind, placebo-controlled trial.
Principal Investigator: Dr Tim Crozier

OMT Study: Peri-operative Evaluation of Sedation depth in Cardiac Surgery: Validity and Reliability of Ocular Micro-Tremor (OMT)
Principal Investigator: Dr Luke OHalloran

Sedation Practice in Intensive Care Evaluation (SPICE) Program: The  SPICE Program is the largest research program on ICU sedation and  delirium management ever conducted. It is a multinational multicenter  program, endorsed by the ANZICS CTG, commenced in 2010 with recruitment  in SPICE III well underway in 4 continents.  The SPICE program provides  many opportunities for sub-studies on delirium, PTSD, cognitive  function, mobility and kinetics. As the Chief Investigator of the SPICE  program, Professor Shehabi has personally conducted site trainings in  Malaysia, Singapore Saudi Arabia, China, United Kingdom and ANZ  throughout the SPICE program. This has led to a paradigm shift in  sedation management in ICUs in Australasia. The results of the SPICE  program will change sedation practice in ICUs around the world.

SPICE III funded by a NHMRC Project Grant 2013-2018, investigates the clinical  effectives of an innovative process of care Early Goal Directed Sedation  (EGDS) compared with Conventional standard care in mechanically  ventilated critically ill patients on 90 day all-cause mortality,  cognitive decline and institutional dependency at 12 months following  randomisation. Multiple secondary outcomes are also investigated,  importantly the incidence and duration of delirium, ventilation free  time and post traumatic stress.

SPICE I and II were  funded by an unrestricted competitive Grant-In-Aid from Hospira Inc.  USA. SPICE I was a multicenter multinational observational study to  establish current sedation practice and identify drivers of poor  outcome. Deep sedation in the first 48 hours was found to independently  predict 6 months mortality. SPICE II was a pilot RCT to test the  feasibility of delivering EGDS and if EGDS reversed the pattern of deep  sedation in the first 48 hours.
Principal Investigator: A/Prof David Ernest

Sepsis Biomarkers, Procalcitonin in Critically Ill Patients with Presumed Sepsis: Procalcitonin  (PCT) is a widely investigated sepsis biomarker with undefined utility  in ICU patients. The first multicenter trial (outside Europe) to examine  its utility in ICU patients was conducted in 12 ICUs around Australia  and funded by a competitive funding from the ANZ Intensive Care  Foundation of A$109,000. In addition PCT machines from different vendors  to the 12 participating sites were procured. The study was completed  and published in the AJRCCM 2014. The ProGUARD RCT suggested that a  hospital wide approach of PCT provides a rich environment for future  research, including the use of PCT in clinical algorithm for antibiotic  stewardship, identification of covert sepsis, secondary infections. 
Principal Investigator: Prof Yahya Shehabi

ICU studies - Dandenong

SPICE Study: Early goal-directed sedation compared with standard care in mechanically ventilated critically ill patients: a prospective multicentre randomised controlled trial.
Principal Investigator: Dr Sanjiv Vij

TRANSFUSE Study: Standard issue transfusion versus fresher blood cell in Intensive Care, a randomised controlled trial.
Principal Investigator: Dr . Sanjiv Vij

IMPLEMENTATION OF THE PAIN, AGITATION AND DELIRIUM (PAD) GUIDELINES INTO AN AUSTRALIAN ICU
Principle Investigator – Dr David Ku

Anaesthesia research activities - Clayton

The role of alpha2 agonists in high risk cardiac surgery: This  program is a collaborative program with Cardiac surgery, cardiac  anaesthesia, intensive care and nephrology. It is a collaborative  project with multiple sites including the National Heart Institute in  Kuala Lumpur. The concept and design of an RCT examining the role of  alpha2 agonist dexmedetomidine on Major Adverse Kidney Events (MAKE)  including 28 days mortality, dialysis or persistent AKIN II-III Acute  Kidney Injury in high risk cardiac surgery has been developed following  an observational study. This study showed a significant reduction in  AKI, delirium and time to extubation in patient treated with  dexmedetomidine.  Nested within the RCT, an AKI biomarker profile  assessment study will be conducted to predict early recognition of AKI  and recovery from renal injury/failure. This RCT is a multinational  multicenter project currently in the preparation phase.
Principal Investigator: Prof Yahya Shehabi

The electrophysiology of sedation and Anaesthesia: The  role of OMT In the absence of gold standard, current methods of  monitoring depth of patient sedation or anaesthesia are either  subjective or do not provide a direct measurement for brainstem  function.  Ocular Micro-Tremor (OMT) is a possible objective alternative  to the current standard of care.   OMT is a fine high frequency tremor  of the eyes caused by extra-ocular muscle activity stimulated by  constant impulses emanating in the brainstem. OMT is present in all  individuals when the eyes are at rest and clinical studies have shown  that a patient’s OMT frequency and amplitude throughout a general  anaesthetic may provide reliable information regarding a patient’s level  of consciousness.  
Clinical sedation scoring systems and subjective  assessments do not allow continuous monitoring of patients under  sedation.  Furthermore, assessments are subject to interpretation by  clinicians and are not applicable at deeper levels of sedation when  patients cannot respond.  Bispectral Index (EEG-based BIS) monitors, a  measure cortical activity, have gained some adoption in surgery, but are  not accurate and exhibit significant variability for agent, patient and  temperature.
Principal Investigator: Prof Yahya Shehabi

The BALANCED Anaesthesia Study: A prospective randomised clinical trial of two levels of anaesthetic depth on patient outcome after major surgery.
Principal Investigator: Dr Jennifer Lucas

ECHOPAC: Agreement in measurement of cardiac output by 2-Dimensional and 3-Dimensional trans oesophageal ECHOcardiography and Pulmonary Artery Catheter thermo dilution during cardiac surgery (ECHOPAC)
Principal Investigator: Dr Martin Kim and Dr David Canty

The GAS Study: A multi-site RCT comparing regional and general anaesthesia for effects on neurodevelopmental outcome and apnoea in infants.
Principal Investigator: Dr Mark Fagjman

The PADDI Trial: The Perioperative Administration of Dexamethasone and Infection.
Principal Investigator: Dr Luke O’Halloran

PINBALL: Prophylactic Intra-aortic BALLoon Counterpulsation in High-Risk Cardiac Surgery: an inception cohort study
Principal Investigator: Professor Julian Smith

The RELIEF Trial: Restrictive versus LIbEral Fluid Therapy in Major Abdominal Surgery.
Principal Investigator: Dr Barbara Rodriguez and Dr Lyndon Siu

The impact of mini-CEX on supervision and training: MiniCEX is now a compulsory workplace-based assessment in anaesthesia training in Australia and New Zealand. This mixed-methods project is a collaboration with the University of Auckland. The project involves reliability analysis of trainees’ mini-CEX scores as well as interviews and surveys exploring trainees’ and supervisors’ understanding and experience of mini-CEX and its impact on learning and supervision.
Principal Investigator: Dr Damian Castanelli

Implementation of the intrinsic ANZCA Roles in Practice: The ‘Roles in Practice’ framework was introduced into the revised Australian and New Zealand College of Anaesthetists’ curriculum in 2013.  This project will investigate the level of educator understanding of these newly prominent intrinsic Roles in Practice and how they are being taught in anaesthetic departments in Australia and New Zealand, if those responsible for supporting registrar training have access to teaching resources in these curriculum areas, and if they would value the development of such resources.
Principal Investigator: Dr Damian Castanelli

Anaesthesia Research Activities – Dandenong

RELIEF: A restrictive fluid regimen for adults undergoing major abdominal surgery leads to reduced complications and improved disability-free survival when compared with a liberal fluid regimen.  A comparison of restricted versus liberal fluids in randomly assigned patient groups undergoing abdominal surgery, with follow up measuring disability free survival over 1 year.
Principal Investigator: Dr Richard Bulach
Associate Investigator: Dr Ashit Das

BALANCED: A prospective randomised clinical trial of measuring 2 levels of depth of anaesthesia, influencing patient recovery after surgery.
Principal Investigator: Dr Richard Bulach
Associate Investigator: Dr Ashit Das

PADDI: The study aims to definitely establish the safety profile of dexamethasone in the perioperative setting. Specifically, it will address the impact of dexamethasone on surgical site infection (primary outcome) and will be stratified according to diabetic status.
Principal Investigator: Dr Richard Bulach
Associate Investigator: Dr Glyn McHutchison.