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.

Inclusion Criteria (all three):

1. 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.

2. Patients not expected to be discharged on the day after their admission.

3. At least one of the following risk factors for acute renal injury:

   1. Age ≥ 65 years
   2. Hypotension (mean arterial pressure [MAP] < 65 mmHg or systolic blood pressure [SBP] < 90 mmHg) or use of vasopressors
   3. Sepsis
   4. Use of invasive mechanical ventilation or of continuous noninvasive mechanical ventilation (including high-flow nasal cannula) > 12 hours
   5. Oliguria (< 0.5 mL/kg/hour for ≥ 3 hours)
   6. Serum creatinine ≥ 1.2 mg/dL for women or ≥ 1.4 mg/dL for men
   7. Liver cirrhosis or acute liver failure

Exclusion Criteria (any of the below):

1. Age < 18 years
2. Acute renal failure treated with renal replacement therapy (RRT) or expected to require RRT within the next 6 hours
3. Severe hyponatremia (serum sodium ≤ 120 mmol/L)
4. Severe hypernatremia (serum sodium ≥ 160 mmol/L)
5. Death considered imminent and inevitable within 24 hours
6. Patients with suspected or confirmed brain death
7. Patients under exclusive palliative care
8. Patients previously enrolled in the BaSICS study

Data will be publicly available two years after trial results have been published