At a glance
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Isotonic Solutions and Major Adverse Renal Events Trial in the Medical Intensive Care Unit
In Brief
A clinical study evaluating 0.9% Saline and Physiologically-balanced isotonic crystalloid for Critical Illness and Acute Kidney Injury. Completed, enrolled 5,381 participants across 1 site.
Detailed Summary
The administration of intravenous fluids is ubiquitous in the care of the critically ill. Commonly available isotonic crystalloid solutions contain a broad spectrum electrolyte compositions including a range chloride concentrations. Recent studies have associated solutions with supraphysiologic chloride content with hyperchloremia, metabolic acidosis and renal vasoconstriction, acute kidney injury and renal replacement therapy, and increased mortality but no large, randomized-controlled trials have been conducted. SMART-MED will be a large, cluster-randomized, multiple-crossover trial enrolling critically ill patients from the Medical ICU at Vanderbilt University from June 2015 until April 2017. The primary endpoint will be the incidence of Major Adverse Kidney Events in 30 days after enrollment (MAKE30 is the composite of death, new renal replacement, or persistent renal dysfunction at discharge).
Study Details
Timeline
Interventions
0.9% Saline will be used whenever an isotonic crystalloid is ordered
Lactated Ringers or Plasma-Lyte© A will be used whenever an isotonic crystalloid is ordered