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

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):

  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

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:
  • Normal Saline
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:
  • Normal Saline

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.

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

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

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.

Clinical Trials on Critical Illness

Clinical Trials on Plasma-Lyte

3
Subscribe