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A protocol for the 0.9% saline versus Plasma-Lyte 148 for intensive care fluid therapy (SPLIT) study
Sumeet K Reddy1, Michael J Bailey2, Richard W Beasley1
1Medical Research Institute of New Zealand, Wellington, New Zealand.
Summary
The SPLIT study protocol compares 0.9% saline with Plasma-Lyte 148 for intensive care unit (ICU) patients. This research investigates potential differences in acute kidney injury (AKI) risk between these common intravenous fluids.
Area of Science:
- Critical Care Medicine
- Nephrology
- Intravenous Fluid Therapy
Background:
- 0.9% saline is a globally prevalent intravenous (IV) fluid.
- Emerging evidence suggests 0.9% saline may elevate acute kidney injury (AKI) risk in intensive care unit (ICU) patients compared to buffered crystalloids like Plasma-Lyte 148.
Purpose of the Study:
- To outline the protocol for the 0.9% Saline v Plasma-Lyte 148 for ICU Fluid Therapy (SPLIT) study.
- To assess the comparative effectiveness of 0.9% saline versus Plasma-Lyte 148 in ICU patients.
Main Methods:
- A multicentre, cluster-randomised, double crossover feasibility study.
- Approximately 2300 ICU patients requiring crystalloid IV fluid therapy will be enrolled.
- Participating ICUs will be randomly assigned to administer either 0.9% saline or Plasma-Lyte 148 in alternating 7-week blocks.
Main Results:
- The primary outcome is the incidence of AKI in ICU patients.
- Secondary outcomes include changes in serum creatinine, need for renal replacement therapy, and mortality (ICU and in-hospital).
- All analyses will adhere to an intention-to-treat principle.
Conclusions:
- The SPLIT study commenced in April 2014.
- Preliminary data will be generated on the comparative efficacy of 0.9% saline and Plasma-Lyte 148 as routine IV fluids in ICU settings.
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