- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02875873
Balanced Solution Versus Saline in Intensive Care Study (BaSICS)
April 15, 2021 updated by: Hospital do Coracao
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
11075
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
SP
-
São Paulo, SP, Brazil, 04005000
- Alexandre Biasi Cavalcanti
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / 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.
|
Plasma-Lyte will be used for fluid expansion and maintenance
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.
|
Plasma-Lyte will be used for fluid expansion and maintenance
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.
|
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.
Saline 0.9% will be used for fluid expansion and maintenance
Other Names:
|
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.
|
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.
Saline 0.9% will be used for fluid expansion and maintenance
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Mortality
Time Frame: 90 days
|
90 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Mechanical ventilation free days
Time Frame: 28 days
|
28 days
|
Renal failure requiring renal replacement therapy
Time Frame: 90 days
|
90 days
|
Renal Injury (KDIGO equal or greater than 2)
Time Frame: Days 3 and 7
|
Days 3 and 7
|
Hepatic, cardiac, neurological, coagulation, and respiratory dysfunctions (assessed by Sequential Organ Failure Assessment [SOFA] scores)
Time Frame: Days 3 and 7
|
Days 3 and 7
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Intensive Care Unit Mortality
Time Frame: At ICU discharge, up to 90 days
|
At ICU discharge, up to 90 days
|
|
Hospital Mortality
Time Frame: At Hospital discharge, up to 90 days
|
At Hospital discharge, up to 90 days
|
|
Length of Intensive Care Unit stay
Time Frame: At ICU discharge, up to 90 days
|
At ICU discharge, up to 90 days
|
|
Length of hospital stay
Time Frame: At hospital discharge, up to 90 days
|
At hospital discharge, up to 90 days
|
|
Quality of Life at 6 months
Time Frame: 180 days
|
Assessed using EQ-5D.
Will only be performed in a subsample of all included patients (10%)
|
180 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 27, 2017
Primary Completion (Actual)
March 2, 2020
Study Completion (Actual)
February 28, 2021
Study Registration Dates
First Submitted
August 15, 2016
First Submitted That Met QC Criteria
August 17, 2016
First Posted (Estimate)
August 23, 2016
Study Record Updates
Last Update Posted (Actual)
April 19, 2021
Last Update Submitted That Met QC Criteria
April 15, 2021
Last Verified
April 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Kidney Diseases
- Urologic Diseases
- Disease Attributes
- Renal Insufficiency
- Critical Illness
- Acute Kidney Injury
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Dopamine Agents
- Dopamine Uptake Inhibitors
- Pharmaceutical Solutions
- Central Nervous System Stimulants
- Sympathomimetics
- Adrenergic Uptake Inhibitors
- Ophthalmic Solutions
- Methamphetamine
- Plasma-lyte 148
Other Study ID Numbers
- basics001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Data will be publicly available two years after trial results have been published
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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