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Balanced Crystalloids versus Saline in the Intensive Care Unit. The SALT Randomized Trial.
Am J Respir Crit Care Med. 2017 05 15; 195(10):1362-1372.AJ

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).

Authors+Show Affiliations

1 Division of Allergy, Pulmonary, and Critical Care Medicine.2 Department of Anesthesiology. 3 Department of Biomedical Informatics.2 Department of Anesthesiology. 3 Department of Biomedical Informatics.4 Department of Pharmaceutical Services.5 Department of Emergency Medicine.6 Vanderbilt Center for Kidney Disease and Integrated Program for AKI, Division of Nephrology and Hypertension, and.7 Department of Biostatistics, Vanderbilt University Medical Center, Nashville, Tennessee.7 Department of Biostatistics, Vanderbilt University Medical Center, Nashville, Tennessee.2 Department of Anesthesiology.1 Division of Allergy, Pulmonary, and Critical Care Medicine.1 Division of Allergy, Pulmonary, and Critical Care Medicine.No affiliation info availableNo affiliation info available

Pub Type(s)

Comparative Study
Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

27749094

Citation

Semler, Matthew W., et al. "Balanced Crystalloids Versus Saline in the Intensive Care Unit. the SALT Randomized Trial." American Journal of Respiratory and Critical Care Medicine, vol. 195, no. 10, 2017, pp. 1362-1372.
Semler MW, Wanderer JP, Ehrenfeld JM, et al. Balanced Crystalloids versus Saline in the Intensive Care Unit. The SALT Randomized Trial. Am J Respir Crit Care Med. 2017;195(10):1362-1372.
Semler, M. W., Wanderer, J. P., Ehrenfeld, J. M., Stollings, J. L., Self, W. H., Siew, E. D., Wang, L., Byrne, D. W., Shaw, A. D., Bernard, G. R., & Rice, T. W. (2017). Balanced Crystalloids versus Saline in the Intensive Care Unit. The SALT Randomized Trial. American Journal of Respiratory and Critical Care Medicine, 195(10), 1362-1372. https://doi.org/10.1164/rccm.201607-1345OC
Semler MW, et al. Balanced Crystalloids Versus Saline in the Intensive Care Unit. the SALT Randomized Trial. Am J Respir Crit Care Med. 2017 05 15;195(10):1362-1372. PubMed PMID: 27749094.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Balanced Crystalloids versus Saline in the Intensive Care Unit. The SALT Randomized Trial. AU - Semler,Matthew W, AU - Wanderer,Jonathan P, AU - Ehrenfeld,Jesse M, AU - Stollings,Joanna L, AU - Self,Wesley H, AU - Siew,Edward D, AU - Wang,Li, AU - Byrne,Daniel W, AU - Shaw,Andrew D, AU - Bernard,Gordon R, AU - Rice,Todd W, AU - ,, AU - ,, PY - 2016/10/18/pubmed PY - 2017/7/20/medline PY - 2016/10/18/entrez KW - acute kidney injury KW - critical illness KW - crystalloid KW - intravenous fluid KW - saline SP - 1362 EP - 1372 JF - American journal of respiratory and critical care medicine JO - Am J Respir Crit Care Med VL - 195 IS - 10 N2 - 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). SN - 1535-4970 UR - https://www.unboundmedicine.com/medline/citation/27749094/Balanced_Crystalloids_versus_Saline_in_the_Intensive_Care_Unit__The_SALT_Randomized_Trial_ DB - PRIME DP - Unbound Medicine ER -