Balanced Solution Versus Saline in Intensive Care Study

NCT ID: NCT02875873

Last Updated: 2021-04-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 11075 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-27
• Study Completion Date: 2021-02-28

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.

Conditions

Critical Illness; Acute Kidney Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Plasma-Lyte

Intervention Type: DRUG

Plasma-Lyte will be used for fluid expansion and maintenance

Slow infusion speed

Intervention Type: OTHER

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.

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.

Group Type: EXPERIMENTAL

Plasma-Lyte

Intervention Type: DRUG

Plasma-Lyte will be used for fluid expansion and maintenance

Fast Infusion Speed

Intervention Type: OTHER

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%, 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.

Group Type: EXPERIMENTAL

Saline 0.9%

Intervention Type: DRUG

Saline 0.9% will be used for fluid expansion and maintenance

Slow infusion speed

Intervention Type: OTHER

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%, 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.

Group Type: EXPERIMENTAL

Saline 0.9%

Intervention Type: DRUG

Saline 0.9% will be used for fluid expansion and maintenance

Fast Infusion Speed

Intervention Type: OTHER

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.

Interventions

Plasma-Lyte

Plasma-Lyte will be used for fluid expansion and maintenance

Intervention Type: DRUG

Saline 0.9%

Saline 0.9% will be used for fluid expansion and maintenance

Intervention Type: DRUG

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.

Intervention Type: 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.

Intervention Type: OTHER

Other Intervention Names

Normal Saline

Eligibility Criteria

Inclusion Criteria

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

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital do Coracao

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alexandre B Cavalcanti, MD, PhD

Role: STUDY_CHAIR

Hospital do Coracao

Fernando G Zampieri, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital do Coracao

Nilton Brandao, MD, PhD

Role: STUDY_DIRECTOR

Hospital Moinhos de Vento

Flávia R Machado, MD, PhD

Role: STUDY_DIRECTOR

Universidade Federal de São Paulo, UNIFESP

Rodrigo S Biondi, MD

Role: STUDY_DIRECTOR

Instituto de Cardiologia do Distrito Federal, ICDF

Flávio G Rezende de Freitas, MD, PhD

Role: STUDY_DIRECTOR

Universidade Federal de São Paulo, Departamento de Cirurgia

Locations

Alexandre Biasi Cavalcanti

São Paulo, São Paulo, Brazil

Countries

Brazil

References

Zampieri FG, Damiani LP, Biondi RS, Freitas FGR, Veiga VC, Figueiredo RC, Serpa-Neto A, Manoel ALO, Miranda TA, Correa TD, Azevedo LCP, Silva NBD, Machado FR, Cavalcanti AB; BRICNet. Effects of balanced solution on short-term outcomes in traumatic brain injury patients: a secondary analysis of the BaSICS randomized trial. Rev Bras Ter Intensiva. 2022 Oct-Dec;34(4):410-417. doi: 10.5935/0103-507X.20220261-pt. Epub 2023 Mar 3.

Reference Type: DERIVED

PMID: 36888820 (View on PubMed)

Zampieri FG, Damiani LP, Bagshaw SM, Semler MW, Churpek M, Azevedo LCP, Figueiredo RC, Veiga VC, Biondi R, Freitas FR, Machado FR, Cavalcanti AB; BRICNet. Conditional Treatment Effect Analysis of Two Infusion Rates for Fluid Challenges in Critically Ill Patients: A Secondary Analysis of Balanced Solution versus Saline in Intensive Care Study (BaSICS) Trial. Ann Am Thorac Soc. 2023 Jun;20(6):872-879. doi: 10.1513/AnnalsATS.202211-946OC.

Reference Type: DERIVED

PMID: 36735931 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 35843046 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 35349397 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 34547081 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 34375394 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 28651514 (View on PubMed)

Other Identifiers

basics001

Identifier Type: -

Identifier Source: org_study_id