Balanced Solution Versus Saline in Intensive Care Study

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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Balanced Solution Versus Saline in Intensive Care Study

Conditions
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Critical Illness, Acute Kidney Injury

Intervention / Treatment
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* Drug: Plasma-Lyte
* Drug: Saline 0.9%
* Other: Slow infusion speed
* Other: Fast Infusion Speed


Participation Criteria
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Eligibility Criteria
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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: Age ≥ 65 years Hypotension (mean arterial pressure [MAP] < 65 mmHg or systolic blood pressure [SBP] < 90 mmHg) or use of vasopressors Sepsis Use of invasive mechanical ventilation or of continuous noninvasive mechanical ventilation (including high-flow nasal cannula) > 12 hours Oliguria (< 0.5 mL/kg/hour for ≥ 3 hours) Serum creatinine ≥ 1.2 mg/dL for women or ≥ 1.4 mg/dL for men Liver cirrhosis or acute liver failure Exclusion Criteria (any of the below): Age < 18 years Acute renal failure treated with renal replacement therapy (RRT) or expected to require RRT within the next 6 hours Severe hyponatremia (serum sodium ≤ 120 mmol/L) Severe hypernatremia (serum sodium ≥ 160 mmol/L) Death considered imminent and inevitable within 24 hours Patients with suspected or confirmed brain death Patients under exclusive palliative care Patients previously enrolled in the BaSICS study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Plasma-Lyte, Slow Infusion<br>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. | Drug: Plasma-Lyte<br>* Plasma-Lyte will be used for fluid expansion and maintenance<br>Other: Slow infusion speed<br>* 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.<br>|
| Experimental: Plasma-Lyte, Fast Infusion<br>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. | Drug: Plasma-Lyte<br>* Plasma-Lyte will be used for fluid expansion and maintenance<br>Other: Fast Infusion Speed<br>* 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.<br>|
| Experimental: Saline 0.9%, Slow Infusion<br>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. | Drug: Saline 0.9%<br>* Saline 0.9% will be used for fluid expansion and maintenance<br>* Other names: Normal Saline;Other: Slow infusion speed<br>* 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.<br>|
| Experimental: Saline 0.9%, Fast Infusion<br>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. | Drug: Saline 0.9%<br>* Saline 0.9% will be used for fluid expansion and maintenance<br>* Other names: Normal Saline;Other: Fast Infusion Speed<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality |  | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Renal failure requiring renal replacement therapy |  | 90 days | 
| Renal Injury (KDIGO equal or greater than 2) |  | Days 3 and 7 | 
| Hepatic, cardiac, neurological, coagulation, and respiratory dysfunctions (assessed by Sequential Organ Failure Assessment [SOFA] scores) |  | Days 3 and 7 | 
| Mechanical ventilation free days |  | 28 days |