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Crit Care Resusc. 2015 Mar;17(1):29-36.

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

Author information

1
Medical Research Institute of New Zealand, Wellington, New Zealand. paul.young@ccdhb.org.nz.
2
Medical Research Institute of New Zealand, Wellington, New Zealand.
3
Department of Anaesthesia, Austin Hospital, Melbourne, VIC, Australia.
4
Intensive Care Unit, The Western Hospital, Melbourne, VIC, Australia.
5
Intensive Care Unit, Geelong Hospital, Geelong, VIC, Australia.
6
Australian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, VIC, Australia.
7
Intensive Care Unit, Wellington Hospital, Wellington, New Zealand.

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 studies within it; an open-label, before-and-after study in emergency department (ED) patients; a single-centre, double-blind, crossover trial in major surgical patients; and a randomised, double-blind study in ICU patients. All studies focus on biochemical and renal outcomes but will also provide preliminary data on patient-centred outcomes including inhospital mortality and requirements for dialysis.

RESULTS AND CONCLUSION:

The SPLIT study program will provide preliminary data on the comparative effectiveness of using 0.9% saline v Plasma-Lyte 148 for IV fluid therapy in ED, surgical and ICU patients.

PMID:
25702759
[Indexed for MEDLINE]

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