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
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
11,075
Plasma-Lyte will be used for fluid expansion and maintenance
Saline 0.9% will be used for fluid expansion and maintenance
Whenever fluid expansion is deemed necessary by the attending physician, infusion speed will be set at 333 mL/h. NOTE: This intervention will not be blinded.
Alexandre Biasi Cavalcanti
São Paulo, São Paulo, Brazil
Mortality
Time frame: 90 days
Renal failure requiring renal replacement therapy
Time frame: 90 days
Renal Injury (KDIGO equal or greater than 2)
Time frame: Days 3 and 7
Hepatic, cardiac, neurological, coagulation, and respiratory dysfunctions (assessed by Sequential Organ Failure Assessment [SOFA] scores)
Time frame: Days 3 and 7
Mechanical ventilation free days
Time frame: 28 days
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Whenever fluid expansion is deemed necessary by the attending physician, infusion speed will be set at 999 mL/h. NOTE: This intervention will not be blinded.