Journal article

Overview of the study protocols and statistical analysis plan for the Saline versus Plasma-Lyte 148 for Intravenous Fluid Therapy (SPLIT) research program

Sumeet K Reddy, Paul J Young, Richard W Beasley, Diane M Mackle, Shay P McGuinness, Colin J McArthur, Seton J Henderson, Laurence Weinberg, Craig J French, Neil R Orford, Michael J Bailey, Rinaldo Bellomo

CRITICAL CARE AND RESUSCITATION | AUSTRALASIAN MED PUBL CO LTD | Published : 2015

Abstract

BACKGROUND: 0.9% saline is the most commonly used intravenous (IV) fluid in the world but recent data raise the possibility that, compared with buffered crystalloid fluids such as Plasma-Lyte 148, the administration of 0.9% saline might increase the risk of developing acute kidney injury. OBJECTIVE: To provide an overview of the study protocols and statistical analysis plan for the six studies making up the (0.9% Saline v Plasma-Lyte 148 for Intravenous Fluid Therapy (SPLIT) research program. METHODS: The SPLIT study consists of six integrated clinical trials, including a double-blind, cluster, randomised, double-crossover study in intensive care unit patients, incorporating two nested studi..

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Grants

Funding Acknowledgements

All studies are investigator initiated and study analyses will be conducted independently of the funding organisations. Study A is primarily funded by a grant from the Health Research Council of New Zealand. The cost of Study B, Study C and Study F have been underwritten by the MRINZ. A funding application has been made to the Australian and New Zealand College of Anaesthetists for Study D. Study E will be funded by the Austin Hospital Intensive Care Trust Fund.