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Balanced Solutions and Plasma Electrolytes

NCT03537898 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2093

Last updated 2019-10-11

No results posted yet for this study

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.

Conditions

  • Critical Illness
  • Acidosis, Metabolic

Interventions

OTHER

Lactated Ringer's

Lactated Ringer's will be used whenever an isotonic crystalloid is ordered

OTHER

Normosol

Normosol-R pH 7.4 will be used whenever an isotonic crystalloid is ordered

Sponsors & Collaborators

  • Vanderbilt University Medical Center

    lead OTHER

Principal Investigators

  • Matthew W Semler, MD, MSc · Vanderbilt University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-01
Primary Completion
2019-02-07
Completion
2019-03-02

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03537898 on ClinicalTrials.gov