Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
53 participants
INTERVENTIONAL
2015-08-31
2017-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Normal Saline Group
the patients included in this group will receive normal saline solution (0.9% sodium chloride) during surgery and in the first 24 hours after ICU admission.
0.9% sodium chloride
Balanced Crystalloid Solution Group
the patients included in this group will receive balanced crystalloid solution during surgery and in the first 24 hours after ICU admission.
balanced crystalloid solution (components: sodium chloride, sodium gluconate, sodium acetate, potassium chloride and magnesium chloride)
Interventions
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balanced crystalloid solution (components: sodium chloride, sodium gluconate, sodium acetate, potassium chloride and magnesium chloride)
0.9% sodium chloride
Eligibility Criteria
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Inclusion Criteria
* Informed consent form signed and dated by legal guardian and investigator
* Informed assent form signed by the patient if appropriate
Exclusion Criteria
* Severe heart, kidney, or pulmonary disease
* non-corrected electrolyte imbalance
* allergy to the solution administered
6 Months
12 Years
ALL
No
Sponsors
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Federal University of São Paulo
OTHER
Responsible Party
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Mariana Fontes Lima Neville
Principal Investigator
Locations
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Federal University of Sao Paulo
São Paulo, São Paulo, Brazil
Countries
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Other Identifiers
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CAAE: 44552315.1.0000.5505
Identifier Type: -
Identifier Source: org_study_id
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