Protocols and Statistical Analysis Plans
Australasian Resuscitation In Sepsis Evaluation: FLUid or vasopressors In emergency Department Sepsis (ARISE FLUIDS) Health Economic Analysis Plan: Higgins A, Howe B, Crous K, Meredith L, Peake S, Macdonald S, Delaney A, Jones P, Keijzers G, Udy A, Williams P, Milford E, Bailey M. Uploaded 12 March 2026.
Statistical analysis plan for the Australasian Resuscitation In Sepsis Evaluation: FLUid or vasopressors In emergency Department Sepsis (ARISE FLUIDS) trial: Milford E, Macdonald S, Serpa Neto A, Delaney A, Higgins A, Howe B, Peake S, for the ARISE FLUIDS Investigators. Uploaded 30th October 2025.
Low OxyGen Intervention for Cardiac Arrest injury Limitation (LOGICAL) trial: Higgins A, Orman Z, Hodgson C, Bailey M, Mather A, Young P, Mackle D. Health Economic Analysis Plan. Uploaded 31 March 2026.
Blend to Limit OxygEN in ECMO: A RanDomised ControllEd Registry Trial (The BLENDER Trial): Higgins A, Burrell A, Pilcher D, Hodgson C, Papanikolaou V, Carrandi L, Ng N, Orman Z, Charles-Nelson A. Health Economic Analysis Plan. Uploaded 22nd July 2025.
A Randomised Controlled Trial of Early Rehabilitation in Patients on Extracorporeal Membrane Oxygenation (ECMO-Rehab). Charles-Nelson A, Hodgson C, Higgins A, Bailey M, Ng N. Statistical Analysis Plan. Uploaded 24th June 2025.
A Multi-Centre Cluster, Cross-Over, Pilot Study Comparing the Safety and Efficacy of Magnesium Loading Followed by Infusion, with Magnesium Intermittent Boluses, in Intensive Care Unit Patients Requiring Vasoactive Pharmacological Support and Invasive Mechanical Ventilation. El-Khawas K, Yan Ho Lee J, Harris D, Eastwood G, Serpa Neto A, Udy A, Bellomo R. Statistical Analysis Plan. Uploaded 12 May 2025.
A Cluster Double Crossover Trial of Early Versus Delayed Aperient Use in Mechanically Ventilated, Enterally Fed Patients. Serpa Neto A, Bellomo R, Tang Y, Eastwood G, Warrillow S. Statistical Analysis Plan. Uploaded 18 December 2024.
Enhancing communication in the intensive care unit: Exploring the use of bedside information boards for patient and family engagement (ISEEU). Hunter S, Bone A, LeFevre P, Keely G, Freeman-Sanderson A. Protocol and Statistical Analysis Plan. Uploaded 5 November 2024.
Health Economic Analysis Plan for the CLIP-II Trial: Comparing cryopreserved platelets with conventional liquid-stored platelets in the management of surgical bleeding. Higgins A, Orman Z, Bailey M, Carrandi L, Howe B, Marks D, Reade M. Health Economic Analysis Plan. Version 1.1. Uploaded 19th December 2024.
Economic Evaluation Analysis Plan for the PROTECTION Trial: Intravenous Amino Acids Therapy as Renal Protection in Cardiac Surgery. Higgins A, Fagery M, Landoni G, Bellomo R. Protocol and Economic Evaluation Analysis Plan. Version 1.1. Uploaded 25 September 2024.
Ketamine for AnaLgesia in MEchanically Ventilated Adults (KALME) trial. Casamento A, Serpa Neto A, Bellomo R. Protocol and Statistical Analysis Plan. Uploaded 31 July 2024.
Angiotensin-II and Thromboembolic Events: A Systematic Review. Caragata R, Johnston SA, Chan JW, Bellomo R. Protocol. Uploaded 5 February 2024.
Sex representation within ICU clinical trials in Australia and New Zealand. Modra L, Bone A, Pilcher D, Orford N, Nair P, Woodward M, Thompson K. Protocol and Statistical Analysis Plan. Uploaded v1 4 September 2023.
Sex differences in vital organ support in Critically Ill Patients in Australia and New Zealand. Modra L, Higgins A, Pilcher D, Bailey M, Bellomo R. Protocol and Statistical Analysis Plan. Uploaded v2 28 November 2022.
Restricted or liberal fluid for haemodynamic resuscitation in sepsis- Protocol for an individual patient data meta-analysis of the ARISE FLUIDS, CLASSIC, CLOVERS and EVIS trials. Macdonald S, Bailey M, Corfield A, Dark P, Delaney A, Gray A, Buhl Hjrortrup P, Howe B, Hylander Moller M, Jones P, Sylvest Mayhoff T, Peake S, Perner A, Shankar-Hari M, Shapiro N, Sivapalan P, Thompson T. Protocol. Uploaded 7 April 2022.
Renal Replacement Therapy Dependence at Day 28 in Critically Ill Patients with Acute Kidney Injury Receiving Continuous or Intermittent Renal Replacement Therapy. Serpa Neto A, Naorungroj T, Bellomo R. Statistical Analysis Plan. Uploaded v1 27 January 2021. Uploaded v2 18 March 2022.
Angiotensin-II for Reduction of Acute Kidney Injury after cardiac surgery – a pilot to determine feasibility of a definitive double blind randomized controlled trial (A-TRAK). Coulson T, Bellomo R, Serpa Neto A. Statistical Analysis Plan. Uploaded 28 Oct 2021
Effect Analgo-Sedation with Morphine vs. Fentanyl on Ventilator-Free Days at Day 28 Among ICU Patients Receiving Invasive Mechanical Ventilation: The ANALGESIC randomized clinical trial. Casamento A, Serpa Neto A, Bellomo R. Statistical Analysis Plan. Uploaded 21/09/2020
Early osmotherapy in severe traumatic brain injury: an international multicentre study. Investigators: Anstey JR, Taccone FS, Udy AA, Citerio G, Duranteau J, Ichai C, Badenes R, Prowle JR , Ercole A, Oddo M, Schneider AG, van der Jagt M, Wolf S, Helbok R, Nelson DR, Skrifvars MB, Harrois A, Presneill J, Cooper DJ, Bailey M, Bellomo R, on behalf of The TBI Collaborative. Statistical Analysis Plan. Uploaded 16 July 2018
Time to haemodynamic effect dissipation after a crystalloid fluid bolus in cardiac surgery patients: a prospective observational study. Investigators: Anthony Wilson, Salvatore Cutuli, Luca Luchetta, Eduardo Osawa, Paolo Ancona, Mark Kubicki, Maria Cronhjort, Neil Glassford, Rinaldo Bellomo. Statistical Analysis Plan. Uploaded 01/05/2018
Fluid bolus of 20% Albumin in post-cardiac surgical patient: a prospective observational study of effect duration. Investigators: Salvatore Cutuli, Eduardo Osawa, Rinaldo Bellomo. Protocol and Statistical Analysis Plan. Uploaded 04/04/2018