Back to resultsBalanced Solution Versus Saline in Intensive Care Study (BaSICS)
Primary Purpose
Critical Illness, Acute Kidney Injury
Status
Completed
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
Plasma-Lyte
Saline 0.9%
Slow infusion speed
Fast Infusion Speed
Sponsored by
About this trial
This is an interventional prevention trial for Critical Illness
Eligibility 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
Sites / Locations
- Alexandre Biasi Cavalcanti
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
Plasma-Lyte, Slow Infusion
Plasma-Lyte, Fast Infusion
Saline 0.9%, Slow Infusion
Saline 0.9%, Fast Infusion
Arm 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.
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.
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.
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.
Outcomes
Primary Outcome Measures
Mortality
Secondary Outcome Measures
Renal failure requiring renal replacement therapy
Renal Injury (KDIGO equal or greater than 2)
Hepatic, cardiac, neurological, coagulation, and respiratory dysfunctions (assessed by Sequential Organ Failure Assessment [SOFA] scores)
Mechanical ventilation free days
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02875873
Brief Title
Balanced Solution Versus Saline in Intensive Care Study
Acronym
BaSICS
Official Title
Balanced Solution Versus Saline in Intensive Care Study
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
May 27, 2017 (Actual)
Primary Completion Date
March 2, 2020 (Actual)
Study Completion Date
February 28, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital do Coracao
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critical Illness, Acute Kidney Injury
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Factorial Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
11075 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Plasma-Lyte, Slow Infusion
Arm Type
Experimental
Arm 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.
Arm Title
Plasma-Lyte, Fast Infusion
Arm Type
Experimental
Arm 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.
Arm Title
Saline 0.9%, Slow Infusion
Arm Type
Experimental
Arm 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.
Arm Title
Saline 0.9%, Fast Infusion
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Plasma-Lyte
Intervention Description
Plasma-Lyte will be used for fluid expansion and maintenance
Intervention Type
Drug
Intervention Name(s)
Saline 0.9%
Other Intervention Name(s)
Normal Saline
Intervention Description
Saline 0.9% will be used for fluid expansion and maintenance
Intervention Type
Other
Intervention Name(s)
Slow infusion speed
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Fast Infusion Speed
Intervention Description
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.
Primary Outcome Measure Information:
Title
Mortality
Time Frame
90 days
Secondary Outcome Measure Information:
Title
Renal failure requiring renal replacement therapy
Time Frame
90 days
Title
Renal Injury (KDIGO equal or greater than 2)
Time Frame
Days 3 and 7
Title
Hepatic, cardiac, neurological, coagulation, and respiratory dysfunctions (assessed by Sequential Organ Failure Assessment [SOFA] scores)
Time Frame
Days 3 and 7
Title
Mechanical ventilation free days
Time Frame
28 days
Other Pre-specified Outcome Measures:
Title
Intensive Care Unit Mortality
Time Frame
At ICU discharge, up to 90 days
Title
Hospital Mortality
Time Frame
At Hospital discharge, up to 90 days
Title
Length of Intensive Care Unit stay
Time Frame
At ICU discharge, up to 90 days
Title
Length of hospital stay
Time Frame
At hospital discharge, up to 90 days
Title
Quality of Life at 6 months
Description
Assessed using EQ-5D. Will only be performed in a subsample of all included patients (10%)
Time Frame
180 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexandre B Cavalcanti, MD, PhD
Organizational Affiliation
Hospital do Coracao
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Fernando G Zampieri, MD
Organizational Affiliation
Hospital do Coracao
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Nilton Brandao, MD, PhD
Organizational Affiliation
Hospital Moinhos de Vento
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Flávia R Machado, MD, PhD
Organizational Affiliation
Universidade Federal de São Paulo, UNIFESP
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Rodrigo S Biondi, MD
Organizational Affiliation
Instituto de Cardiologia do Distrito Federal, ICDF
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Flávio G Rezende de Freitas, MD, PhD
Organizational Affiliation
Universidade Federal de São Paulo, Departamento de Cirurgia
Official's Role
Study Director
Facility Information:
Facility Name
Alexandre Biasi Cavalcanti
City
São Paulo
State/Province
SP
ZIP/Postal Code
04005000
Country
Brazil
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Data will be publicly available two years after trial results have been published
Citations:
PubMed Identifier
35843046
Citation
Zampieri FG, Damiani LP, Biondi RS, Freitas FGR, Veiga VC, Figueiredo RC, Serpa-Neto A, Manoel ALO, Miranda TA, Correa TD, Azevedo LCP, Silva NB, Machado FR, Cavalcanti AB; BRICNet. Hierarchical endpoint analysis using win ratio in critical care: An exploration using the balanced solutions in intensive care study (BaSICS). J Crit Care. 2022 Oct;71:154113. doi: 10.1016/j.jcrc.2022.154113. Epub 2022 Jul 14.
Results Reference
derived
PubMed Identifier
35349397
Citation
Zampieri FG, Machado FR, Biondi RS, Freitas FGR, Veiga VC, Figueiredo RC, Lovato WJ, Amendola CP, Serpa-Neto A, Paranhos JLR, Lucio EA, Oliveira-Junior LC, Lisboa TC, Lacerda FH, Maia IS, Grion CMC, Assuncao MSC, Manoel ALO, Correa TD, Guedes MAVA, Azevedo LCP, Miranda TA, Damiani LP, Brandao da Silva N, Cavalcanti AB. Association between Type of Fluid Received Prior to Enrollment, Type of Admission, and Effect of Balanced Crystalloid in Critically Ill Adults: A Secondary Exploratory Analysis of the BaSICS Clinical Trial. Am J Respir Crit Care Med. 2022 Jun 15;205(12):1419-1428. doi: 10.1164/rccm.202111-2484OC.
Results Reference
derived
PubMed Identifier
34547081
Citation
Zampieri FG, Machado FR, Biondi RS, Freitas FGR, Veiga VC, Figueiredo RC, Lovato WJ, Amendola CP, Assuncao MSC, Serpa-Neto A, Paranhos JLR, Andrade J, Godoy MMG, Romano E, Dal Pizzol F, Silva EB, Silva MML, Machado MCV, Malbouisson LMS, Manoel ALO, Thompson MM, Figueiredo LM, Soares RM, Miranda TA, de Lima LM, Santucci EV, Correa TD, Azevedo LCP, Kellum JA, Damiani LP, Silva NB, Cavalcanti AB; BaSICS investigators and the BRICNet members. Effect of Slower vs Faster Intravenous Fluid Bolus Rates on Mortality in Critically Ill Patients: The BaSICS Randomized Clinical Trial. JAMA. 2021 Sep 7;326(9):830-838. doi: 10.1001/jama.2021.11444.
Results Reference
derived
PubMed Identifier
34375394
Citation
Zampieri FG, Machado FR, Biondi RS, Freitas FGR, Veiga VC, Figueiredo RC, Lovato WJ, Amendola CP, Serpa-Neto A, Paranhos JLR, Guedes MAV, Lucio EA, Oliveira-Junior LC, Lisboa TC, Lacerda FH, Maia IS, Grion CMC, Assuncao MSC, Manoel ALO, Silva-Junior JM, Duarte P, Soares RM, Miranda TA, de Lima LM, Gurgel RM, Paisani DM, Correa TD, Azevedo LCP, Kellum JA, Damiani LP, Brandao da Silva N, Cavalcanti AB; BaSICS investigators and the BRICNet members. Effect of Intravenous Fluid Treatment With a Balanced Solution vs 0.9% Saline Solution on Mortality in Critically Ill Patients: The BaSICS Randomized Clinical Trial. JAMA. 2021 Aug 10;326(9):1-12. doi: 10.1001/jama.2021.11684. Online ahead of print.
Results Reference
derived
PubMed Identifier
28651514
Citation
Zampieri FG, Azevedo LCP, Correa TD, Falavigna M, Machado FR, Assuncao MSC, Lobo SMA, Dourado LK, Berwanger O, Kellum JA, Brandao N, Cavalcanti AB; BaSICS Investigators and the BRICNet. Study protocol for the Balanced Solution versus Saline in Intensive Care Study (BaSICS): a factorial randomised trial. Crit Care Resusc. 2017 Jun;19(2):175-182.
Results Reference
derived
Learn more about this trial
Balanced Solution Versus Saline in Intensive Care Study
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