Balanced Solutions and Plasma Electrolytes

• Status: Recruiting
• Trial end date: 2019-03-02
• Target enrollment: 2000
• Participant gender: All

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 prospective, randomized trials have shown improved patient outcomes with the use of balanced crystalloids compared to saline. There have not been large randomized studies comparing acetate buffered balanced crystalloids to non-acetate buffered balanced crystalloids in the critically ill. BASE will be a pilot study for a large, cluster-randomized, multiple-crossover trial enrolling critically ill patients from the Medical ICU at Vanderbilt University from June 2018 until January 2019. The primary endpoint will be plasma bicarbonate concentration between Intensive Care Unit admission and hospital discharge.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vanderbilt University Medical Center
• Treatments: Pharmaceutical Solutions; Plasma-lyte 148

Criteria

Inclusion Criteria:

• Patients admitted to the Medical ICU during the study period (Enrolled patients who are discharged from the hospital are eligible again if they are readmitted to the Medical ICU during the study period)

Exclusion Criteria:

• Age < 18 years old

• Prisoners