Abstract:
Rationale: The effects of balanced crystalloid versus saline on
clinical outcomes for ICU patients may be modified by the type
of fluid that patients received for initial resuscitation and by the
type of admission.
Objectives: To assess whether the results of a randomized
controlled trial could be affected by fluid use before enrollment
and admission type.
Methods: Secondary post hoc analysis of the BaSICS (Balanced
Solution in Intensive Care Study) trial, which compared a
balanced solution (Plasma-Lyte 148) with 0.9% saline in the ICU.
Patients were categorized according to fluid use in the 24 hours
before enrollment in four groups (balanced solutions only, 0.9%
saline only, a mix of both, and no fluid before enrollment) and
according to admission type (planned, unplanned with sepsis,
and unplanned without sepsis). The association between 90-day
mortality and the randomization group was assessed using a
hierarchical logistic Bayesian model.
Measurements and Main Results: A total of 10,520 patients
were included. There was a low probability that the balanced
solution was associated with improved 90-day mortality in the
whole trial population (odds ratio [OR], 0.95; 89% credible
interval [CrI], 0.66–10.51; probability of benefit, 0.58); however,
probability of benefit was high for patients who received only
balanced solutions before enrollment (regardless of admission
type, OR, 0.78; 89% CrI, 0.56–1.03; probability of benefit, 0.92),
mostly because of a benefit in unplanned admissions due to
sepsis (OR, 0.70; 89% CrI, 0.50–0.97; probability of benefit, 0.96)
and planned admissions (OR, 0.79; 89% CrI, 0.65–0.97;
probability of benefit, 0.97).
Conclusions: There is a high probability that balanced solution
use in the ICU reduces 90-day mortality in patients who
exclusively received balanced fluids before trial enrollment.
Clinical trial registered with www.clinicaltrials.gov
(NCT 02875873).
