Balanced Solution Versus Saline in Intensive Care Study

Critical Illness Clinical Trial

— BaSICS  

Official title:

Balanced Solution Versus Saline in Intensive Care Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02875873
• Other study ID #: basics001
• Status: Completed
• Phase: Phase 3
• Start date: May 27, 2017
• Est. completion date: February 28, 2021

Study information

• Verified date: April 2021
• Source: Hospital do Coracao
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11075
• Est. completion date: February 28, 2021
• Est. primary completion date: March 2, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Kidney Injury
• Critical Illness

Intervention

Drug:
• Plasma-Lyte
Plasma-Lyte will be used for fluid expansion and maintenance
• Saline 0.9%
Saline 0.9% 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.
• 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.

Locations

Country	Name	City	State
Brazil	Alexandre Biasi Cavalcanti	São Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
Hospital do Coracao

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Intensive Care Unit Mortality		At ICU discharge, up to 90 days
Other	Hospital Mortality		At Hospital discharge, up to 90 days
Other	Length of Intensive Care Unit stay		At ICU discharge, up to 90 days
Other	Length of hospital stay		At hospital discharge, up to 90 days
Other	Quality of Life at 6 months	Assessed using EQ-5D. Will only be performed in a subsample of all included patients (10%)	180 days
Primary	Mortality		90 days
Secondary	Renal failure requiring renal replacement therapy		90 days
Secondary	Renal Injury (KDIGO equal or greater than 2)		Days 3 and 7
Secondary	Hepatic, cardiac, neurological, coagulation, and respiratory dysfunctions (assessed by Sequential Organ Failure Assessment [SOFA] scores)		Days 3 and 7
Secondary	Mechanical ventilation free days		28 days