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Research

Research

Prof Paul Myles and Dr Stefan Dieleman, Anaesthesia Research Fellow at Monash and Alfred, reviewing an echo result

The research unit is headed by Professor Paul Myles, and funded through a number of large NHMRC grants. Paul is supported by an NHMRC Practitioner Fellowship.

Our staff

Sophie Wallace, Research Manager
Andrea Ditoro, Research Assistant
Aimee Neylan, Research Assistant
Ruby Han, Research Assistant
Mayumi Ueoka, Research Assistant
Alice Cazalet, Office Assistant

Research trials and studies

The unit manages and participates in numerous multicentre and local clinical trials and studies at any one time.

Current and upcoming trials

ITACS

IV iron for Treatment of Anaemia before Cardiac Surgery
This randomised, double-blind, controlled, phase 4 trial will compare the efficacy, safety and cost-effectiveness of preoperative IV iron with placebo in patients with anaemia before elective cardiac surgery.

MIDAS

Measurements Investigating Disability After Surgery
MIDAS is a perioperative registry project following the postoperative recovery of surgical patients over 70 years old.

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ERAS

Implementation of an Enhanced Recovery After Surgery (ERAS) Program for Hip and Knee Replacement Surgery
The aims of this implementation project are to reduce clinical variation and improve quality of care, by measuring the extent and outcomes of ERAS-based care across the Monash Partners hospitals, including successful implementation of ERAS principles (early feeding, ambulation, pain control), shorter recovery times, lower complication rates (wound infection, hospital readmission), and reduced hospital stay.

Prospective Cohort Study of Pharmacokinetics of Cephazolin Prophylaxis in Cardia

Prospective Cohort Study of Pharmacokinetics of Cephazolin Prophylaxis in Cardiac Surgery with Cardiopulmonary Bypass (Optimal antibiotic dose to prevent infections following cardiac surgery) In patients receiving cephazolin prophylaxis for cardiac surgery requiring cardiopulmonary bypass, we hypothesise that serum, sternal subcutaneous, and bone cephazolin concentrations will be sub-optimal, when standard doses (according to Therapeutic Guidelines: Antibiotics) are employed.

Optimise II

Optimisation of Perioperative Cardiovascular Management to Improve Surgical Outcome II
Open, multi-centre, randomised controlled trial of cardiac output-guided fluid therapy with low dose inotrope infusion compared to usual care in patients undergoing major elective gastrointestinal surgery.

DECS II

DexamEthasone for Cardiac Surgery Trial
A multicentre, pragmatic, assessor-blinded, randomised trial of dexamethasone (1 mg/kg, single dose) versus placebo in 2,800 patients undergoing cardiac surgery, employing a novel, highly efficient trial design.

ROCKet

Reduction Of Chronic Post-surgical Pain with Ketamine
A large multicentre double-blind placebo controlled randomised trial of the effect of perioperative ketamine on the risk of development of chronic post-surgical pain

The TRIGS trial

This multicentre, pragmatic, double-blind, randomised clinical trial will compare the incidence of surgical site infection and red cell transfusion requirements after IV tranexamic acid and placebo in patients undergoing gastrointestinal surgery

A multi-centre, patient and assessor-blinded, parallel groups, randomised contro

A multi-centre, patient and assessor-blinded, parallel groups, randomised controlled trial (RCT) comparing both restricted and liberal oxygen therapy with standard care in patients having major surgery

Is preoperative TTE-evaluated diastolic dysfunction an independent outcome predi

Is preoperative TTE-evaluated diastolic dysfunction an independent outcome predictor after cardiac surgery? An observational cohort study.

NATO

A prospective observational study to determine if non-anaemic iron deficiency increases the risk of poor post-operative outcome relative to an iron replete control in patients undergoing surgery for colorectal malignancy.

ORION

The aim of the ORION trial is to compare the use of post-operative metoprolol to placebo for efficacy (myocardial ischemia and myocardial injury) and safety (clinically relevant hypotension) outcomes in Beta-blocker naïve patients with high cardiac risk undergoing elective, major, non-cardiac surgery with general anesthesia.

Evaluation of the Antidepressant Effects of Nitrous Oxide in People with Major D

Evaluation of the Antidepressant Effects of Nitrous Oxide in People with Major Depressive Disorder

We are conducting a randomised trial to evaluate the antidepressant effects of nitrous oxide in people with major depressive disorder. This project will further evaluate these effects and identify the optimal dose and regimen to guide current practice, and to plan a future large pragmatic trial.

RELIEF CKD

All patients were previously consented to be contacted at 1 year after surgery, plus have their medical records reviewed up to that time, in the original study protocol. We would now like to undertake a further review of the patients’ medical records, aiming to obtain more information about their kidney function (primarily, blood test results: serum creatinine). In Australia there were 1677 patients that were consented and followed up to 12 months during the RELIEF trial.

Recently completed Studies

PADDI

The Perioperative ADministration of Dexamethasone and Infection
The PADDI Trial is a large international, multicentre, prospective, randomised, double blind, placebo-controlled, parallel assessment, stratified, non-inferiority safety and effectiveness study. Its purpose is to establish the safety of the administration of 8 mg of dexamethasone to adult patients undergoing non-urgent surgical procedures under general anaesthesia of at least two hours duration and requiring at least one night’s stay in hospital postoperatively.

Does creatinine production rate change perioperatively in patients undergoing...

Does creatinine production rate change perioperatively in patients undergoing cardiac surgery
The primary objective of the study is to determine whether the rate of creatinine production increases in the perioperative period in adult patients undergoing cardiac surgery.

Cephazolin in cardiac surgery

An evaluation of the agreement between transthoracic and trans...

An evaluation of the agreement between transthoracic and trans esophageal echocardiography for the assessment of left ventricular diastolic dysfunction in patients undergoing cardiac surgery
The primary aim of the proposed study is to measure the agreement between awake, preoperative transthoracic echocardiography (preTTE) and intraoperative transesophageal echocardiography (iTOE), performed prior to surgical incision, for the evaluation and grading of diastolic dysfunction in adult patients undergoing cardiac surgery.

RELIEF

REstrictive versus LIbEral Fluid therapy in major abdominal surgery

Published papers: In review

Published protocol papers

Myles PS, Bellomo R, Corcoran T, Forbes A, Wallace S, Peyton P, Christophi C, Story D, Leslie K, Serpell J, McGuinness S, Parke R; and the Australian and New Zealand College of Anaesthetists Clinical Trials Network, and the Australian and New Zealand Intensive Care Society Clinical Trials Group. Restrictive versus liberal fluid therapy in major abdominal surgery (RELIEF): rationale and design for a multicentre randomised trial. BMJ Open 2017;7:e015358. doi:10.1136/bmjopen-2016-015358
Myles PS, Bellomo R, Corcoran T, Forbes A, Peyton P, Story D, Christophi C, Leslie K, McGuinness S, Parke R, Serpell J, Chan MTV, Painter T, McCluskey S, Minto G, Wallace S; Australian and New Zealand College of Anaesthetists Clinical Trials Network and the Australian and New Zealand Intensive Care Society Clinical Trials Group. Restrictive versus Liberal Fluid Therapy for Major Abdominal Surgery. N Engl J Med. 2018 Jun 14;378(24):2263-2274. doi: 10.1056/NEJMoa1801601. Epub 2018 May 9.

ATACAS Trial

Aspirin and Tranexamic Acid for Coronary Artery Surgery Trial
ACTA Clinical Trial of the Year 2017

Published papers:

Myles PS, Smith JA, Forbes A, Silbert B, Jayarajah M, Painter T, Cooper DJ, Marasco S, McNeil J, Bussières JS, Wallace S, for the ATACAS investigators of the ANZCA Clinical Trials Network. Stopping vs. continuing aspirin before coronary artery surgery. N Engl J Med 2016; 374:728-737.
Myles PS, Smith JA, Forbes A, Silbert B, Jayarajah M, Painter T, Cooper D J, Marasco S, McNeil J, Bussieres JS, McGuinness, S, Byrne, K, Chan MTV, Landoni G, Wallace S, ATACAS Investigators of the ANZCA Clinical Trials Network. Tranexamic acid in patients undergoing coronary artery surgery. N Engl J Med 2017; 376: 136-148. *Featured in Research Highlights section of Nature Reviews Cardiology

Recovery after Major Surgery

Recovery and Well-being after Major Surgery
Complications, functional recovery, and the measurement of disability-free survival. Recruiting 500 sequential patients from four centres, coordinated at the Department of Anaesthesia and Perioperative Medicine, Alfred Hospital. Funded through ANZCA.

Published paper

Shulman MA, Myles PS, McIlroy DR, Wallace S, Ponsford J. The measurement of disability-free survival after surgery. Anesthesiology 2015; 122:524-536. *accompanying Editorial

TRICS III Trial

Transfusion Requirements In Cardiac Surgery (TRICS-III) Trial

Published paper:

C. David Mazer, M.D., Richard P. Whitlock, M.D., Ph.D., Dean A. Fergusson, Ph.D., M.H.A., Judith Hall, M.Sc., Emilie Belley-Cote, M.D., Katherine Connolly, M.D., Boris Khanykin, M.D., Alexander J. Gregory, M.D., Étienne de Médicis, M.D., Shay McGuinness, M.B., Ch.B., Alistair Royse, M.B., B.S., M.D., François M. Carrier, M.D., Paul J. Young, F.C.I.C.M., Ph.D., Juan C. Villar, M.D., Ph.D., Hilary P. Grocott, M.D., Manfred D. Seeberger, M.D., Stephen Fremes, M.D., François Lellouche, M.D., Ph.D., Summer Syed, M.D., Kelly Byrne, M.B., Ch.B., Sean M. Bagshaw, M.D., Nian C. Hwang, M.B., B.S., G.D.Acu., Chirag Mehta, M.D., Thomas W. Painter, M.B., Ch.B., Colin Royse, M.B., B.S., M.D., Subodh Verma, M.D., Ph.D., Gregory M.T. Hare, M.D., Ph.D., Ashley Cohen, M.Sc., Kevin E. Thorpe, M.Math., Peter Jüni, M.D., and Nadine Shehata, M.D., for the TRICS Investigators and Perioperative Anesthesia Clinical Trials Group* Restrictive or Liberal Red-Cell Transfusion for Cardiac Surgery. N Engl J Med 2017; 377:2133-2144

METS

Measurement of Exercise Tolerance for Surgery (METS) Study
To compare preoperative CPET to physicians’ subjective assessment of functional capacity for predicting postoperative 30-day death or non-fatal myocardial infarction in patients undergoing major elective non-cardiac surgery.

Published paper:

Wijeysundera DN, Pearse RM, Shulman MA, Abbott TEF, Torres E, Croal BL Granton JT, Thorpe KE, Grocott MP, Farrington C, Myles PS, Cuthbertson BH, on behalf of the METS Study Investigators. Measurement of exercise tolerance before surgery (METS) study: a protocol for an international multicentre prospective cohort study of cardiopulmonary exercise testing prior to major noncardiac surgery. BMJ Open, 6(3) doi:http://dx.doi.org/10.1136/bmjopen-2015-010359

BALANCED

BALANCED
The influence of anaesthetic depth on patient outcome after major surgery

Published paper

Short TG, Leslie K, Chan MT, Campbell D, Frampton C, Myles P. Rationale and design of the balanced anesthesia study: a prospective randomized clinical trial of two levels of anesthetic depth on patient outcome after major surgery. Anesth Analg 2015; 121:357-65.

EPICS-Australasia

Epidemiology of Critical care provision after Surgery

POISE 2

POISE 2 is a large, international, placebo-controlled, factorial trial to assess the impact of clonidine and acetyl-salicylic acid (ASA) in patients undergoing noncardiac surgery who are at risk of a perioperative cardiovascular event.

Published paper:

Garg A, Kurz A, Sessler DI, Cuerden M, Robinson A, Mrkobrada M, Parikh C, Mizera R, Jones PM, Tiboni M, Rodriguez RG, Popova E, Gomez MFR, Meyhoff CS, Vanhelder T, Chan MTV, Torres D, Parlow J, Clanchet MdN, Amir M, Bidgoli SJ, Pasin L, Martinsen K, Malaga G, Myles P, et al. Aspirin and clonidine in non-cardiac surgery: acute kidney injury substudy protocol of the Perioperative Ischaemic Evaluation (POISE) 2 randomised controlled trial. BMJ Open 2014;4:e004886. doi:10.1136/bmjopen-2014-004886

ENIGMA-II Trial

Nitrous oxide anaesthesia and cardiac morbidity after major surgery

Published paper:

Myles PS, Leslie K, Chan MTV, Forbes A, Peyton P, Paech M, Beattie S, Sessler D, Devereaux PJ, Silbert BS, Schricker T, Wallace S, and the ANZCA Trials Group for the ENIGMA-II investigators. The safety of addition of nitrous oxide to general anaesthesia in at-risk patients having major non-cardiac surgery (ENIGMA-II): a randomised, single-blind trial. Lancet 2014; 384:1446-1454.

Iron NOF

Intravenous Iron to reduce transfusion and improve post-operative haemoglobin in patients with fractured Neck of Femur to reduce the burden of red blood cell transfusion in patients with fractured neck of femur by the use of intravenous iron transfusion.

LICRA

Limiting I.V. Chloride to Reduce Acute kidney injury
The LICRA study aims to test the impact of a strategy of perioperative chloride-restriction through intravenous (IV) fluid therapy on the incidence of acute kidney injury after cardiac surgery. LICRA is a prospective, open-label, single-centre 4-period sequential study including all patients undergoing surgery by the Department of Cardiothoracic Surgery within the study period. Available IV fluids are categorized as either chloride-rich or chloride-poor and the study involves a unit-wide policy switch in the type of administered intravenous fluid according to pre-defined calendar dates.

ENIGMA

Myles PS, Leslie K, Chan MT, Forbes A, Paech MJ, Peyton P, Silbert BS, Pascoe E; ENIGMA Trial Group. Avoidance of nitrous oxide for patients undergoing major surgery: a randomized controlled trial. Anesthesiology. 2007 Aug;107(2):221-31.

B-AWARE

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POISE

POISE Study Group, Devereaux PJ, Yang H, Yusuf S, Guyatt G, Leslie K, Villar JC, Xavier D, Chrolavicius S, Greenspan L, Pogue J, Pais P, Liu L, Xu S, Málaga G, Avezum A, Chan M, Montori VM, Jacka M, Choi P. Effects of extended-release metoprolol succinate in patients undergoing non-cardiac surgery (POISE trial): a randomised controlled trial. Lancet. 2008 May 31;371(9627):1839-47. Epub 2008 May 12.

ISOS

International Surgical Outcomes Study
The primary outcome measure is in-hospital all cause mortality at 30 days following surgery. The secondary outcome measures are number of admissions to critical care and duration of hospital stay.

Registrar projects

In addition, registrars receive specialist training in Anaesthesia, and each registrar must complete a research project as part of their specialist qualifications. During 2017, seven projects were completed, including randomised trials and audits.