A protocol for the 0.9% saline versus Plasma-Lyte 148 for intensive care fluid therapy (SPLIT) study.

Abstract

BACKGROUND:

0.9% saline is the most commonly used intravenous (IV) fluid in the world. However, recent data raise the possibility that, compared with buffered crystalloid fluids such as Plasma-Lyte 148, the administration of 0.9% saline to intensive care unit patients might increase their risk of acute kidney injury (AKI).

OBJECTIVE:

To describe the protocol for the 0.9% Saline v Plasma-Lyte 148 for ICU Fluid Therapy (SPLIT) study.

METHODS:

This is a multicentre, cluster-randomised, double crossover feasibility study to be conducted in four New Zealand tertiary ICUs over a 28-week period and will enroll about 2300 participants. All ICU patients who need crystalloid IV fluid therapy (except those with established renal failure needing dialysis and those admitted to the ICU for palliative care) will be enrolled. Participating ICUs will be randomly assigned to 0.9% saline or Plasma-Lyte 148 as the routine crystalloid IV fluid, in a blinded fashion, in four alternating 7-week blocks.

MAIN OUTCOME MEASURES:

The primary outcome will be the proportion of patients who develop AKI in the ICU. Secondary outcomes will include the difference between the most recent serum creatinine level measured before study enrollment and the peak serum creatinine level in the ICU; use of renal replacement therapy; and ICU and in hospital mortality. All analyses will be conducted on an intention-to-treat basis.

RESULTS AND CONCLUSION:

The SPLIT study started on 1 April 2014 and will provide preliminary data on the comparative effectiveness of using 0.9% saline v Plasma- Lyte 148 as the routine IV fluid therapy in ICU patients.

• Authors: Sumeet K Reddy, Michael J Bailey, Richard W Beasley, Rinaldo Bellomo, Seton J Henderson, Diane M Mackle, Colin J McArthur, Jan E Mehrtens, John A Myburgh, Shay P McGuinness, Alex J Psirides, Paul J Young
• Journal: Critical care and resuscitation : journal of the Australasian Academy of Critical Care Medicine (Crit Care Resusc) Vol. 16 Issue 4 Pg. 274-9 (Dec 2014) ISSN: 1441-2772 [Print] Australia
• PMID: 25437221 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Cardioplegic Solutions
• Gluconates
• Plasma-lyte 148
• Magnesium Chloride
• Sodium Chloride
• Sodium Acetate
• Potassium Chloride
• Creatinine

Topics

• Acute Kidney Injury
• Blood Flow Velocity
• Cardioplegic Solutions (therapeutic use)
• Clinical Protocols
• Creatinine (blood)
• Critical Care
• Cross-Over Studies
• Fluid Therapy (methods)
• Gluconates (therapeutic use)
• Humans
• Magnesium Chloride (therapeutic use)
• Potassium Chloride (therapeutic use)
• Renal Artery (physiopathology)
• Research Design
• Sodium Acetate (therapeutic use)
• Sodium Chloride (therapeutic use)