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May - 2017

   

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Balanced Crystalloids versus Saline in the Intensive Care Unit. The SALT Randomized Trial

M Semler, J Wanderer, J Ehrenfeld, et al for the SALT Investigators and the Pragmatic Critical Care Research Group Am J Resp Crit Care Med, 2017, 195(10);1362-1372

Comment

A number of trials are trying to answer the saline vs balanced crystalloid in critical illness question. The reason is the high chloride content of saline is hypothesised to contribute to the development of AKI. This pilot cluster-randomised, multiple crossover trial describes the outcomes of 974 adults admitted to a single ICU in a 4-month period in 2015, with monthly alternating saline vs balanced crystalloid at a unit level. 

They described;

  • They used software tools built into the EHR to automatically enrolled, steer ordering providers to the correct crystalloid, collect data
  • Characteristics: patients were similar at baseline, received similar volumes of crystalloid in the first 30d. Of note at enrolment only 34% were ventilated, 24% receiving vasopressors, 19% AKI.
  • Primary outcome: Difference in proportion of isotonic crystalloid administered that was saline (90% Saline group vs 21% Balanced group, p<0.001)
  • Secondary outcome: The major adverse kidney events within 30 days (MAKE30), a composite of death, dialysis, or persistent renal dysfunction (24.7% Saline vs 24.6%, p= 0.98)
  • Subgroup: Among patients receiving higher volumes of fluid, a higher incidence of MAKE30 was observed in the saline group (P value for interaction 0.026)

This study primarily tells us that it is possible to use a software tool to run a fluid trial, and deliver very effective treatment separation. This is by itself interesting, and if it can be developed further, very useful for high volume enrolment critical care trials. The secondary issue is about the actual trial question, does balanced crystalloid reduce AKI. The simple answer is no, although it is only a pilot, and the “dose-response” effect seen may be enough to stimulate larger trials. 

 

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.

May


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