article165

SALT-ED

"Balanced Crystalloids versus Saline in Noncritically Ill Adults". The New England Journal of Medicine. 2018. 378:819-828. PubMed • Full text • PDF.

Clinical Question

Does treatment with balanced crystalloids result in a more favorable outcome than saline in noncritically ill adults treated with intravenous fluids in the emergency department?

Bottom Line

Treatment with balanced crystalloids did not result in a higher number of hospital-free days, but did result in a lower incidence of major adverse kidney events within 30 days, compared to saline.

Major Points

Guidelines

As of the study's publication, no specific guidelines were established reflecting the results of this trial.

Design

Single-center, pragmatic, multiple-crossover trial comparing balanced crystalloids to saline in adults treated with intravenous crystalloids in the emergency department, not admitted to an ICU.
N=13,347 patients
Balanced Crystalloids (n=6708)
Saline (n=6639)
Setting: Vanderbilt University Medical Center Adult Emergency Department
Enrollment: January 1, 2016, to April 30, 2017
Mean follow-up: N/A
Primary outcome: Hospital-free days to day 28
Secondary outcomes: Major adverse kidney events within 30 days, acute kidney injury of stage 2 or higher, in-hospital death
Analysis: Intention-to-treat

Population

Inclusion Criteria:
Adults (≥18 years old)
Received at least 500 ml of intravenous isotonic crystalloids in the emergency department
Subsequently hospitalized outside an ICU
Exclusion Criteria:
Patients admitted directly to an ICU from the emergency department
Patients who received less than 500 ml of crystalloids in the emergency department
Baseline Characteristics: Similar between the two groups including demographics, coexisting conditions, admitting service, and renal function

Interventions

Patients received crystalloids based on the assigned calendar month (balanced crystalloids or saline)
Lactated Ringer’s solution represented 95.3% of the balanced crystalloids

Outcomes

Primary Outcomes:
No difference in hospital-free days between the balanced crystalloids and saline groups. (Median, 25 days; adjusted odds ratio with balanced crystalloids, 0.98; 95% CI, 0.92 to 1.04; P=0.41)
Secondary Outcomes:
Lower incidence of major adverse kidney events within 30 days in the balanced-crystalloids group (4.7% vs 5.6%; adjusted odds ratio, 0.82; 95% CI, 0.70 to 0.95; P=0.01)
Stage 2 or higher acute kidney injury and in-hospital death did not differ significantly between the two groups

Criticisms

Single-center trial with potential limited external validity.
Unblinded design could introduce bias.
Limited outcome ascertainment to index_gpt hospitalization.
Control of fluids after the hospital admission was not included in the trial intervention.
Use of Plasma-Lyte A was minimal; further study required to compare it with saline and lactated Ringer’s solution.

Funding

Supported by the Vanderbilt Institute for Clinical and Translational Research and others. The trial also received funds from several NIH grants and from the Department of Veterans Affairs Health Services Research and Development Service.