Balanced Solution Versus Saline in Intensive Care Study (BaSICS)

Hospital do Coracao

Status and phase: Completed; Phase 3

Conditions: Acute Kidney Injury; Critical Illness

Treatments: Other: Slow infusion speed; Drug: Plasma-Lyte; Drug: Saline 0.9%; Other: Fast Infusion Speed

Study type: Interventional

Funder types: Other

Identifiers

NCT02875873

basics001

Details and patient eligibility

About

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.

Enrollment: 11,075 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Quadruple Blind

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11,075 participants in 4 patient groups

Plasma-Lyte, Slow Infusion

Experimental group

Description:

Plasma-Lyte will be used for fluid expansion and maintenance whenever needed and when there is no contraindication either for Plasma-Lyte or normal saline. Whenever fluid expansion is deemed necessary by the attending physician, infusion speed will be set at 333 mL/h.

Treatment:

Drug: Plasma-Lyte

Other: Slow infusion speed

Plasma-Lyte, Fast Infusion

Experimental group

Description:

Plasma-Lyte will be used for fluid expansion and maintenance whenever needed and when there is no contraindication either for Plasma-Lyte or normal saline. Whenever fluid expansion is deemed necessary by the attending physician, infusion speed will be set at 999 mL/h.

Treatment:

Drug: Plasma-Lyte

Other: Fast Infusion Speed

Saline 0.9%, Slow Infusion

Experimental group

Description:

Saline 0.9% will be used for fluid expansion and maintenance whenever needed and when there is no contraindication either for Plasma-Lyte or normal saline. Whenever fluid expansion is deemed necessary by the attending physician, infusion speed will be set at 333 mL/h.

Treatment:

Drug: Saline 0.9%

Other: Slow infusion speed

Saline 0.9%, Fast Infusion

Experimental group

Description:

Saline 0.9% will be used for fluid expansion and maintenance whenever needed and when there is no contraindication either for Plasma-Lyte or normal saline. Whenever fluid expansion is deemed necessary by the attending physician, infusion speed will be set at 999 mL/h.

Treatment:

Drug: Saline 0.9%

Other: Fast Infusion Speed