Back to resultsFluid Therapy During Brain Tumor Resection in Children
Primary Purpose
Brain Neoplasms
Status
Completed
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
balanced crystalloid solution (components: sodium chloride, sodium gluconate, sodium acetate, potassium chloride and magnesium chloride)
0.9% sodium chloride
Sponsored by
About this trial
This is an interventional treatment trial for Brain Neoplasms focused on measuring crystalloid solutions, acid-base imbalance, water-electrolyte Imbalance
Eligibility Criteria
Inclusion Criteria:
- Children undergoing elective craniotomy for brain tumor resection
- Informed consent form signed and dated by legal guardian and investigator
- Informed assent form signed by the patient if appropriate
Exclusion Criteria:
- Uncontrolled Intracranial hypertension
- Severe heart, kidney, or pulmonary disease
- non-corrected electrolyte imbalance
- allergy to the solution administered
Sites / Locations
- Federal University of Sao Paulo
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Normal Saline Group
Balanced Crystalloid Solution Group
Arm Description
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.
the patients included in this group will receive balanced crystalloid solution during surgery and in the first 24 hours after ICU admission.
Outcomes
Primary Outcome Measures
serum chloride difference (mmol/L)
Serum chloride will be collected in two different moments: right before the beginning of the surgery and right after de end of the procedure. We will calculate the difference between the two values.
Secondary Outcome Measures
serum chloride difference (mmol/L)
Serum chloride will be collected right after the end of the surgery as well as 24 hours after the admission in ICU. We will calculate the difference between the two values.
brain relaxation score
serum sodium difference (mmol/L)
Serum sodium will be collected in two different moments: right before the beginning of the surgery and right after de end of the procedure. We will calculate the difference between the two values.
Full Information
NCT ID
NCT02707549
First Posted
March 6, 2016
Last Updated
November 12, 2017
Sponsor
Federal University of São Paulo
1. Study Identification
Unique Protocol Identification Number
NCT02707549
Brief Title
Fluid Therapy During Brain Tumor Resection in Children
Official Title
Comparison of Balanced Crystalloid Solution and 0,9% Sodium Chloride in Children Undergoing Brain Tumor Resection: a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
August 2015 (Actual)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
June 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of São Paulo
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Fluid management of children during neurosurgery is not well established. Hypotonic solutions, commonly still used in pediatric patients, may enhance cerebral edema and worse operative conditions. This study compares two different isotonic solutions administered perioperatively regarding acid base and fluid electrolyte disturbances.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Neoplasms
Keywords
crystalloid solutions, acid-base imbalance, water-electrolyte Imbalance
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
53 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Normal Saline Group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Balanced Crystalloid Solution Group
Arm Type
Experimental
Arm Description
the patients included in this group will receive balanced crystalloid solution during surgery and in the first 24 hours after ICU admission.
Intervention Type
Drug
Intervention Name(s)
balanced crystalloid solution (components: sodium chloride, sodium gluconate, sodium acetate, potassium chloride and magnesium chloride)
Intervention Type
Drug
Intervention Name(s)
0.9% sodium chloride
Primary Outcome Measure Information:
Title
serum chloride difference (mmol/L)
Description
Serum chloride will be collected in two different moments: right before the beginning of the surgery and right after de end of the procedure. We will calculate the difference between the two values.
Time Frame
from the admission of the patient in the operating room until the end of the surgery.
Secondary Outcome Measure Information:
Title
serum chloride difference (mmol/L)
Description
Serum chloride will be collected right after the end of the surgery as well as 24 hours after the admission in ICU. We will calculate the difference between the two values.
Time Frame
from the end of the surgery until exactly 24 hours after the admission in intensive care unit (ICU)
Title
brain relaxation score
Time Frame
immediately after dura-mater opening
Title
serum sodium difference (mmol/L)
Description
Serum sodium will be collected in two different moments: right before the beginning of the surgery and right after de end of the procedure. We will calculate the difference between the two values.
Time Frame
from the admission of the patient in the operating room until the end of the surgery.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Children undergoing elective craniotomy for brain tumor resection
Informed consent form signed and dated by legal guardian and investigator
Informed assent form signed by the patient if appropriate
Exclusion Criteria:
Uncontrolled Intracranial hypertension
Severe heart, kidney, or pulmonary disease
non-corrected electrolyte imbalance
allergy to the solution administered
Facility Information:
Facility Name
Federal University of Sao Paulo
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
04023-062
Country
Brazil
12. IPD Sharing Statement
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Fluid Therapy During Brain Tumor Resection in Children
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