BaSICS: Balanced Solution Versus Saline in Intensive Care Study
Study Details
Study Description
Brief Summary
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Detailed 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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Plasma-Lyte, Slow Infusion 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
Plasma-Lyte will be used for fluid expansion and maintenance
Other: Slow infusion speed
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.
|
| Experimental: Plasma-Lyte, Fast Infusion 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
Plasma-Lyte will be used for fluid expansion and maintenance
Other: Fast Infusion Speed
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.
|
| Experimental: Saline 0.9%, Slow Infusion 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%
Saline 0.9% will be used for fluid expansion and maintenance
Other Names:
Other: Slow infusion speed
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.
|
| Experimental: Saline 0.9%, Fast Infusion 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%
Saline 0.9% will be used for fluid expansion and maintenance
Other Names:
Other: Fast Infusion Speed
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.
|
Outcome Measures
Primary Outcome Measures
- Mortality [90 days]
Secondary Outcome Measures
- 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]
Other Outcome Measures
- Intensive Care Unit Mortality [At ICU discharge, up to 90 days]
- Hospital Mortality [At Hospital discharge, up to 90 days]
- Length of Intensive Care Unit stay [At ICU discharge, up to 90 days]
- Length of hospital stay [At hospital discharge, up to 90 days]
- Quality of Life at 6 months [180 days]
Assessed using EQ-5D. Will only be performed in a subsample of all included patients (10%)
Eligibility Criteria
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:
-
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Alexandre Biasi Cavalcanti | São Paulo | SP | Brazil | 04005000 |
Sponsors and Collaborators
- Hospital do Coracao
Investigators
- Study Chair: Alexandre B Cavalcanti, MD, PhD, Hospital do Coracao
- Principal Investigator: Fernando G Zampieri, MD, Hospital do Coracao
- Study Director: Nilton Brandao, MD, PhD, Hospital Moinhos de Vento
- Study Director: Flávia R Machado, MD, PhD, Universidade Federal de São Paulo, UNIFESP
- Study Director: Rodrigo S Biondi, MD, Instituto de Cardiologia do Distrito Federal, ICDF
- Study Director: Flávio G Rezende de Freitas, MD, PhD, Universidade Federal de São Paulo, Departamento de Cirurgia
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- basics001