Balanced Solution Versus Saline in Intensive Care Study

NCT02875873 | Completed Phase 3 DMC

• 1 other identifier: basics001
• Study Type: interventional
• Target: 11,075
• Locations: 1 country
• Sites: 1

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

Conditions

Critical Illness; Acute Kidney Injury

Outcome Measures

Primary Outcomes (1)

• Mortality

  90 days

Secondary Outcomes (4)

• 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 Outcomes (5)

• 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

Study Arms (4)

Plasma-Lyte, Slow Infusion

EXPERIMENTAL

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; Other: Slow infusion speed

Plasma-Lyte, Fast Infusion

EXPERIMENTAL

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; Other: Fast Infusion Speed

Saline 0.9%, Slow Infusion

EXPERIMENTAL

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%; Other: Slow infusion speed

Saline 0.9%, Fast Infusion

EXPERIMENTAL

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%; Other: Fast Infusion Speed

Interventions

Plasma-Lyte DRUG

Plasma-Lyte will be used for fluid expansion and maintenance

Plasma-Lyte, Fast Infusion; Plasma-Lyte, Slow Infusion

Saline 0.9% DRUG

Saline 0.9% will be used for fluid expansion and maintenance

Also known as: Normal Saline

Saline 0.9%, Fast Infusion; Saline 0.9%, Slow Infusion

Slow infusion speed 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, Slow Infusion; Saline 0.9%, Slow Infusion

Fast Infusion Speed 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.

Plasma-Lyte, Fast Infusion; Saline 0.9%, Fast Infusion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital do Coracao: lead

Study Sites (1)

Alexandre Biasi Cavalcanti

São Paulo, São Paulo, 04005000, Brazil

Location

Related Publications (7)

• 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.

  PMID: 36888820 DERIVED

• 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.

  PMID: 36735931 DERIVED

• 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.

  PMID: 35843046 DERIVED

• 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.

  PMID: 35349397 DERIVED

• 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.

  PMID: 34547081 DERIVED

• 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.

  PMID: 34375394 DERIVED

• 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.

  PMID: 28651514 DERIVED

MeSH Terms

Conditions

Critical Illness; Acute Kidney Injury

Interventions

Plasma-lyte 148; Sodium Chloride; Saline Solution

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Alexandre B Cavalcanti, MD, PhD

  Hospital do Coracao

  STUDY CHAIR

• Fernando G Zampieri, MD

  Hospital do Coracao

  PRINCIPAL INVESTIGATOR

• 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 DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2016
• First Posted: August 23, 2016
• Study Start: May 27, 2017
• Primary Completion: March 2, 2020
• Study Completion: February 28, 2021
• Last Updated: April 19, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will share

Locations

BR (1)