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A 2x2 factorial randomized study to evaluate the effect of a balanced crystalloid solution compared with 0.9% saline, and of rapid vs. slow infusion on clinical outcomes of critically ill patients
Full description
Pragmatic, multicenter, 2x2 factorial randomized study. Severe patients admitted to the ICU at moderate to high risk for death or acute kidney injury will be randomly allocated to receive a balanced crystalloid solution (Plasma-Lyte®) or 0.9% saline and to receive crystalloids by rapid bolus infusion (999 mL/h) or slow infusion (333 mL/h) whenever plasma expansion is needed.
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Inclusion and exclusion criteria
Inclusion Criteria (all three):
Need for plasma expansion, and the clinician considers that Plasma-Lyte® or 0.9% saline are equally appropriate for patients, with no specific indications or contraindications for any of the fluids or for rapid or slow infusion.
Patients not expected to be discharged on the day after their admission.
At least one of the following risk factors for acute renal injury:
Exclusion Criteria (any of the below):
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Interventional model
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11,075 participants in 4 patient groups
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Data sourced from clinicaltrials.gov
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