Clinical trial NCT02875873: Balanced Solution Versus Saline in Intensive Care Study
Official title: Balanced Solution Versus Saline in Intensive Care Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Critical Illness
Acute Kidney Injury
Lead sponsor: Hospital do Coracao
Sponsor class: OTHER
First posted: 2016-08-23
Enrollment: 11075
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Mortality
timeFrame: 90 days
Secondary outcomes:
measure: Renal failure requiring renal replacement therapy
timeFrame: 90 days
measure: Renal Injury (KDIGO equal or greater than 2)
timeFrame: Days 3 and 7
measure: Hepatic, cardiac, neurological, coagulation, and respiratory dysfunctions (assessed by Sequential Organ Failure Assessment [SOFA] scores)
timeFrame: Days 3 and 7
measure: Mechanical ventilation free days
timeFrame: 28 days
Other outcomes:
measure: Intensive Care Unit Mortality
timeFrame: At ICU discharge, up to 90 days
measure: Hospital Mortality
timeFrame: At Hospital discharge, up to 90 days
measure: Length of Intensive Care Unit stay
timeFrame: At ICU discharge, up to 90 days
measure: Length of hospital stay
timeFrame: At hospital discharge, up to 90 days
measure: Quality of Life at 6 months
timeFrame: 180 days
Locations:
city: São Paulo
country: Brazil
facility: Alexandre Biasi Cavalcanti
state: SP
Study officials:
affiliation: Hospital do Coracao
name: Alexandre B Cavalcanti, MD, PhD
role: STUDY_CHAIR
affiliation: Hospital do Coracao
name: Fernando G Zampieri, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Moinhos de Vento
name: Nilton Brandao, MD, PhD
role: STUDY_DIRECTOR
affiliation: Universidade Federal de São Paulo, UNIFESP
name: Flávia R Machado, MD, PhD
role: STUDY_DIRECTOR
affiliation: Instituto de Cardiologia do Distrito Federal, ICDF
name: Rodrigo S Biondi, MD
role: STUDY_DIRECTOR
affiliation: Universidade Federal de São Paulo, Departamento de Cirurgia
name: Flávio G Rezende de Freitas, MD, PhD
role: STUDY_DIRECTOR
References:
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.
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.
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.
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.
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.