Balanced crystalloids versus saline in the intensive care unit: study protocol for a cluster-randomized,
Matthew W Semler1, Wesley H Self2, Li Wang3
1Division of Allergy, Pulmonary, and Critical Care Medicine, Vanderbilt University Medical Center, C-1216 MCN, 1161 21st Avenue South, Nashville, TN, 37232-2650, USA. matthew.w.semler@vanderbilt.edu.
Trials
|March 18, 2017
Summary
Balanced crystalloids may reduce the risk of acute kidney injury and death in critically ill adults compared to saline. This trial investigates the impact of intravenous fluid choice on major adverse kidney events and mortality in intensive care units.
Area of Science:
- Critical Care Medicine
- Nephrology
- Intravenous Fluid Therapy
Background:
- Saline, a common intravenous fluid for critically ill adults, has a high chloride content potentially linked to acute kidney injury and mortality.
- The comparative safety and efficacy of balanced crystalloids versus saline in this population remain under investigation.
Purpose of the Study:
- To compare the incidence of Major Adverse Kidney Events (MAKE) within 30 days between critically ill adults receiving balanced crystalloids versus saline.
- To evaluate the impact of intravenous fluid choice on mortality, renal function, and other clinical outcomes in intensive care unit (ICU) patients.
Main Methods:
- The Isotonic Solutions and Major Adverse Renal Events Trial (SMART) is a pragmatic, cluster-randomized crossover trial involving approximately 14,000 adult ICU patients.
- The trial compares saline (0.9% sodium chloride) with balanced crystalloids (lactated Ringer's or Plasma-Lyte A®), with ICUs alternating fluid assignments monthly.
- The primary outcome is a composite of in-hospital death, new renal replacement therapy, or persistent renal dysfunction at 30 days.
Main Results:
- This section is not available in the provided abstract.
- Further details on the trial's main results will be available upon study completion.
Conclusions:
- The ongoing SMART trial is the largest comparison of saline versus balanced crystalloids in critically ill adults.
- Results will inform clinical practice regarding optimal intravenous fluid selection to improve patient outcomes and reduce kidney injury.
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