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Trial record 3 of 5 for:    The Plasma-Lyte 148 Versus Saline (PLUS) study

Balanced Solution Versus Saline in Intensive Care Study (BaSICS)

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ClinicalTrials.gov Identifier: NCT02875873
Recruitment Status : Recruiting
First Posted : August 23, 2016
Last Update Posted : March 8, 2019
Sponsor:
Collaborators:
Hospital Moinhos de Vento
Hospital Sirio-Libanes
Information provided by (Responsible Party):
Hospital do Coracao

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

Condition or disease Intervention/treatment Phase
Critical Illness Acute Kidney Injury Drug: Plasma-Lyte Drug: Saline 0.9% Other: Slow infusion speed Other: Fast Infusion Speed Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 11000 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Balanced Solution Versus Saline in Intensive Care Study
Actual Study Start Date : May 27, 2017
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : April 2021

Resource links provided by the National Library of Medicine


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.
Drug: Plasma-Lyte
Plasma-Lyte will be used for fluid expansion and maintenance

Other: 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.

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.
Drug: Plasma-Lyte
Plasma-Lyte will be used for fluid expansion and maintenance

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.

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.
Drug: Saline 0.9%
Saline 0.9% will be used for fluid expansion and maintenance
Other Name: Normal Saline

Other: 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.

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.
Drug: Saline 0.9%
Saline 0.9% will be used for fluid expansion and maintenance
Other Name: Normal Saline

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.




Primary Outcome Measures :
  1. Mortality [ Time Frame: 90 days ]

Secondary Outcome Measures :
  1. Renal failure requiring renal replacement therapy [ Time Frame: 90 days ]
  2. Renal Injury (KDIGO equal or greater than 2) [ Time Frame: Days 3 and 7 ]
  3. Hepatic, cardiac, neurological, coagulation, and respiratory dysfunctions (assessed by Sequential Organ Failure Assessment [SOFA] scores) [ Time Frame: Days 3 and 7 ]
  4. Mechanical ventilation free days [ Time Frame: 28 days ]

Other Outcome Measures:
  1. Intensive Care Unit Mortality [ Time Frame: At ICU discharge, up to 90 days ]
  2. Hospital Mortality [ Time Frame: At Hospital discharge, up to 90 days ]
  3. Length of Intensive Care Unit stay [ Time Frame: At ICU discharge, up to 90 days ]
  4. Length of hospital stay [ Time Frame: At hospital discharge, up to 90 days ]
  5. 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%)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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. Hyperkalemia (serum potassium ≥ 5.5 mmol/L)
  6. Death considered imminent and inevitable within 24 hours
  7. Patients with suspected or confirmed brain death
  8. Patients under exclusive palliative care
  9. Patients previously enrolled in the BaSICS study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02875873


Contacts
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Contact: Alexandre B Cavalcanti, MD, PhD +551130536611 ext 8102 abiasi@hcor.com.br
Contact: Fernando G Zampieri, MD +551130536611 ext 8239 fzampieri@hcor.com.br

Locations
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Brazil
Alexandre Biasi Cavalcanti Recruiting
São Paulo, SP, Brazil, 04005000
Contact: Karina Normilio-Silva    55xx1130536611 ext 8204    knsilva@hcor.com.br   
Contact: Alexandre B Cavalcanti, MD,PhD    55xx1130536611 ext 8102    abiasi@hcor.com.br   
Principal Investigator: Alexandre B Cavalcanti, MD.Phd         
Sponsors and Collaborators
Hospital do Coracao
Hospital Moinhos de Vento
Hospital Sirio-Libanes
Investigators
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Study Director: Alexandre B Cavalcanti, MD, PhD Hospital do Coracao
Study Director: Fernando G Zampieri, MD Hospital do Coracao
Study Director: Luciano CP Azevedo, MD, PhD Hospital Sirio-Libanes
Study Director: Maicon Falavigna, MD, PhD Hospital Moinhos de Vento
Study Director: Nilton Brandao, MD, PhD Hospital Moinhos de Vento
Study Director: Otavio Berwanger, MD, PhD Hospital do Coracao

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Hospital do Coracao
ClinicalTrials.gov Identifier: NCT02875873     History of Changes
Other Study ID Numbers: basics001
First Posted: August 23, 2016    Key Record Dates
Last Update Posted: March 8, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data will be publicly available two years after trial results have been published

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Plasma-lyte 148
Acute Kidney Injury
Critical Illness
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Disease Attributes
Pathologic Processes
Methamphetamine
Central Nervous System Stimulants
Physiological Effects of Drugs
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Dopamine Uptake Inhibitors
Ophthalmic Solutions
Pharmaceutical Solutions