Study protocol and statistical analysis plan for the 20% Human Albumin Solution Fluid Bolus Administration Therapy in Patients after Cardiac Surgery-ll (HAS FLAIR-II) trial

Geoffrey Wigmore; Adam M Deane; James Anstey; Michael Bailey; Shailesh Bihari; Glenn Eastwood; Rashmi Ghanpur; Matthew J Maiden; Jeffrey J Presneill; Jaishankar Raman; Rinaldo Bellomo; HAS FLAIR-II trial investigators

doi:10.51893/2022.4.OA1

Study protocol and statistical analysis plan for the 20% Human Albumin Solution Fluid Bolus Administration Therapy in Patients after Cardiac Surgery-ll (HAS FLAIR-II) trial

Crit Care Resusc. 2023 Oct 16;24(4):309-318. doi: 10.51893/2022.4.OA1. eCollection 2022 Dec 5.

Authors

Geoffrey Wigmore^{1

2}, Adam M Deane^{2

3}, James Anstey^{2

3}, Michael Bailey⁴, Shailesh Bihari⁵, Glenn Eastwood⁶, Rashmi Ghanpur^{6

7}, Matthew J Maiden^{8

9

10}, Jeffrey J Presneill^{2

3

4}, Jaishankar Raman^{11

12

13

14}, Rinaldo Bellomo^{2

6}; HAS FLAIR-II trial investigators

Affiliations

¹ Department of Anaesthesia, Western Health, Melbourne, VIC, Australia.
² Department of Critical Care, University of Melbourne, Melbourne, VIC, Australia.
³ Department of Intensive Care, Royal Melbourne Hospital, Melbourne, VIC, Australia.
⁴ Australian and New Zealand Intensive Care Research Centre (ANZIC-RC), School of Public Health and Preventative Medicine, Monash University, Melbourne, VIC, Australia.
⁵ Department of Intensive and Critical Care Medicine, Flinders Medical Centre, Adelaide, SA, Australia.
⁶ Department of Intensive Care, Austin Hospital, Melbourne, VIC, Australia.
⁷ Intensive care Unit, Warringal Private hospital, Melbourne, VIC, Australia.
⁸ Discipline of Acute Care Medicine, University of Adelaide, Adelaide, SA, Australia.
⁹ Intensive Care Unit, Royal Adelaide Hospital, Adelaide, SA, Australia.
¹⁰ Intensive Care Unit, Barwon Health, Geelong, VIC, Australia.
¹¹ University of Melbourne, Melbourne, VIC, Australia.
¹² St Vincent's Hospital Melbourne, Melbourne, VIC, Australia.
¹³ Deakin University, Melbourne, VIC, Australia.
¹⁴ University of Illinois at Urbana-Champaign, Urbana (IL), USA.

Abstract

Background: Fluid bolus therapy with 20% albumin may shorten the duration of vasopressor therapy in patients after cardiac surgery. Objective: To describe the study protocol and statistical analysis plan for the 20% Human Albumin Solution Fluid Bolus Administration Therapy in Patients after Cardiac Surgery-II (HAS FLAIR-II) trial. Design, setting, participants and intervention: HAS FLAIR-II is a phase 2b, multicentre, parallel group, openlabel, randomised controlled trial that will be conducted at six Australian intensive care units. Patients requiring fluid bolus therapy after cardiac surgery will be randomly assigned in a 1:1 ratio to the intervention of fluid bolus therapy with 20% albumin or a comparator of fluid bolus therapy with a crystalloid solution. Main outcome measures: The primary outcome measure is the cumulative duration of vasopressor therapy. Secondary outcomes include vasopressor use, service utilisation, and mortality. All analyses will be conducted on an intention-to-treat basis. Results and conclusion: The study protocol and statistical analysis plan will guide the conduct and analysis of the HAS FLAIR-II trial, such that analytical and reporting biases are minimised. Trial registration: This trial has been registered with the Australian New Zealand Clinical Trials Registry (ACTRN No. 12620000137998).