Faculty Collaboration Database

Balanced Crystalloids versus Saline in the Intensive Care Unit. The SALT Randomized Trial. Am J Respir Crit Care Med 2017 May 15;195(10):1362-1372

Date

10/18/2016

Pubmed ID

27749094

Pubmed Central ID

PMC5443900

DOI

10.1164/rccm.201607-1345OC

Scopus ID

2-s2.0-85019876588 (requires institutional sign-in at Scopus site)   173 Citations

Abstract

RATIONALE: Saline is the intravenous fluid most commonly administered to critically ill adults, but it may be associated with acute kidney injury and death. Whether use of balanced crystalloids rather than saline affects patient outcomes remains unknown.

OBJECTIVES: To pilot a cluster-randomized, multiple-crossover trial using software tools within the electronic health record to compare saline to balanced crystalloids.

METHODS: This was a cluster-randomized, multiple-crossover trial among 974 adults admitted to a tertiary medical intensive care unit from February 3, 2015 to May 31, 2015. The intravenous crystalloid used in the unit alternated monthly between saline (0.9% sodium chloride) and balanced crystalloids (lactated Ringer's solution or Plasma-Lyte A). Enrollment, fluid delivery, and data collection were performed using software tools within the electronic health record. The primary outcome was the difference between study groups in the proportion of isotonic crystalloid administered that was saline. The secondary outcome was major adverse kidney events within 30 days (MAKE30), a composite of death, dialysis, or persistent renal dysfunction.

MEASUREMENTS AND MAIN RESULTS: Patients assigned to saline (n = 454) and balanced crystalloids (n = 520) were similar at baseline and received similar volumes of crystalloid by 30 days (median [interquartile range]: 1,424 ml [500-3,377] vs. 1,617 ml [500-3,628]; P = 0.40). Saline made up a larger proportion of the isotonic crystalloid given in the saline group than in the balanced crystalloid group (91% vs. 21%; P < 0.001). MAKE30 did not differ between groups (24.7% vs. 24.6%; P = 0.98).

CONCLUSIONS: An electronic health record-embedded, cluster-randomized, multiple-crossover trial comparing saline with balanced crystalloids can produce well-balanced study groups and separation in crystalloid receipt. Clinical trial registered with www.clinicaltrials.gov (NCT 02345486).

Author List

Semler MW, Wanderer JP, Ehrenfeld JM, Stollings JL, Self WH, Siew ED, Wang L, Byrne DW, Shaw AD, Bernard GR, Rice TW, SALT Investigators * and the Pragmatic Critical Care Research Group, SALT Investigators

Author

Jesse Ehrenfeld MD, MPH Sr Associate Dean, Director, Professor in the Advancing a Healthier Wisconsin Endowment department at Medical College of Wisconsin

MESH terms used to index this publication - Major topics in bold

Adult
Aged
Cluster Analysis
Critical Care
Critical Illness
Cross-Over Studies
Female
Fluid Therapy
Humans
Intensive Care Units
Isotonic Solutions
Male
Middle Aged
Sodium Chloride