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evident

SALT-ED

Balanced Crystalloids versus Saline in Noncritically Ill Adults

Overview

In noncritically ill adults given IV fluids in the ED, balanced crystalloids did not change hospital-free days versus saline.

Clinical takeaway

The primary outcome, hospital-free days, did not differ. A secondary kidney composite (MAKE-30) was lower with balanced crystalloids; that is not the trial's primary result.

Key result

Hospital-free days were a median of 25 days in each group (adjusted OR 0.98, 95% CI 0.92-1.04; P=0.41). Secondary MAKE-30 was 4.7% with balanced crystalloids vs 5.6% with saline (adjusted OR 0.82, 95% CI 0.70-0.95; P=0.01).

Practice impact

Do not choose balanced crystalloids in the ED expecting more hospital-free days; the primary outcome was null. A secondary kidney composite favored balanced fluids.

Evidence

Study design

Single-center, pragmatic, multiple-crossover trial in which the entire emergency department crossed over monthly between balanced crystalloids and saline during a 16-month period.

Enrollment

13,347

Follow-up

Hospital-free days before day 28; major adverse kidney events censored at hospital discharge or 30 days.

Geography

Not listed

Clinical question

Do balanced crystalloids increase hospital-free days compared with saline in noncritically ill adults treated with intravenous fluids in the emergency department?

Population

  • Adults treated with intravenous crystalloids in the emergency department and subsequently hospitalized outside an ICU.

Intervention

Balanced crystalloids (lactated Ringer's solution or Plasma-Lyte A) as the assigned emergency-department crystalloid.

Comparator

Saline as the assigned emergency-department crystalloid.

Primary outcome

Hospital-free days (days alive after discharge before day 28).

There was no difference in hospital-free days between balanced crystalloids and saline.

Adjusted odds ratio with balanced crystalloids / 0.98 / 95% CI 0.92-1.04 / p=0.41

Key results

  • Among 13,347 enrolled patients, the median crystalloid volume in the emergency department was 1079 ml, and 88.3% exclusively received the assigned crystalloid.
  • Hospital-free days, the primary outcome, did not differ (median 25 days in each group; adjusted odds ratio with balanced crystalloids 0.98, 95% CI 0.92-1.04; P=0.41).
  • As a secondary outcome, major adverse kidney events within 30 days occurred in 4.7% with balanced crystalloids vs 5.6% with saline (adjusted odds ratio 0.82, 95% CI 0.70-0.95; P=0.01).

Harms

  • Major adverse kidney events within 30 days, a secondary composite of death, new renal-replacement therapy, or persistent renal dysfunction, were lower with balanced crystalloids (4.7% vs 5.6%; adjusted OR 0.82, 95% CI 0.70-0.95; P=0.01).

Clinical Use

Practice impact

  • Do not switch emergency-department crystalloid expecting more days alive and out of the hospital; SALT-ED's primary outcome was the same with both fluids.
  • If the concern is a kidney-centered composite, the secondary MAKE-30 result favored balanced crystalloids and should be labeled as secondary.

Applicability

  • Most applicable to noncritically ill adults who receive intravenous crystalloids in the emergency department and are then admitted outside an ICU, in a single-center monthly-crossover system.

Limitations

  • Assignment was by calendar month for the entire emergency department, not by individual randomization.
  • The trial was single-center.
  • The kidney result is a secondary outcome and is not the basis for the authors' primary conclusion.
  • Median emergency-department crystalloid volume was 1079 ml, so this is not a large-volume ICU resuscitation trial.

Common misinterpretations

  • MAKE-30 is not the primary end point. Hospital-free days did not differ.
  • SALT-ED is not the same question as balanced crystalloids versus saline in critically ill ICU patients.

Related evidence

Citation

Self WH, Semler MW, Wanderer JP, et al. Balanced Crystalloids versus Saline in Noncritically Ill Adults. N Engl J Med. 2018;378(9):819-828. doi:10.1056/NEJMoa1711586

Among noncritically ill adults treated with intravenous fluids in the emergency department, there was no difference in hospital-free days between treatment with balanced crystalloids and treatment with saline.