NCT02614040

Saline Against Lactated Ringers or Plasmalyte in the Emergency Department

Saline Against Lactated Ringers or Plasmalyte in the Emergency Department (SaLt-ED)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 14,000 (actual)
• Sponsor: Vanderbilt University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will be a cluster-randomized, single-center trial comparing 0.9% saline (normal saline) vs physiologically-balanced crystalloid fluids (Lactated Ringers or Plasmalyte A) for intravenous fluid administration in the emergency department.

Detailed description

The administration of intravenous fluids is ubiquitous in the care of the acutely ill. Commonly available isotonic crystalloid solutions contain a broad spectrum of 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. SaLt-ED will be a large, cluster-randomized trial enrolling adults requiring intravenous isotonic crystalloid administration and hospital admission from the Vanderbilt University Emergency Department from January 1st 2016 until April 30 2017. The primary endpoint will be hospital-free days to day 28.

Conditions

• Critical Illness
• Acute Kidney Injury

Interventions

Type	Name	Description
OTHER	0.9% Saline	0.9% Saline will be used whenever an isotonic crystalloid is ordered
OTHER	Physiologically-balanced isotonic crystalloid	Lactated Ringers or Plasma-Lyte© A will be used whenever an isotonic crystalloid is ordered

Timeline

• Start date: 2016-01-01
• Primary completion: 2017-06-30
• Completion: 2017-06-30
• First posted: 2015-11-25
• Last updated: 2017-09-15

Locations

1 site across 1 country: United States