- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02707549
Fluid Therapy During Brain Tumor Resection in Children
November 12, 2017 updated by: Mariana Fontes Lima Neville, Federal University of São Paulo
Comparison of Balanced Crystalloid Solution and 0,9% Sodium Chloride in Children Undergoing Brain Tumor Resection: a Randomized Controlled Trial
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.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
53
Phase
- Phase 2
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
-
Sao Paulo, SP, Brazil, 04023-062
- Federal University of São Paulo
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-
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
6 months to 12 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
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: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 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.
|
|
Experimental: 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
serum chloride difference (mmol/L)
Time Frame: from the admission of the patient in the operating room until the end of the surgery.
|
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.
|
from the admission of the patient in the operating room until the end of the surgery.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
serum chloride difference (mmol/L)
Time Frame: from the end of the surgery until exactly 24 hours after the admission in intensive care unit (ICU)
|
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.
|
from the end of the surgery until exactly 24 hours after the admission in intensive care unit (ICU)
|
brain relaxation score
Time Frame: immediately after dura-mater opening
|
immediately after dura-mater opening
|
|
serum sodium difference (mmol/L)
Time Frame: from the admission of the patient in the operating room until the end of the surgery.
|
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.
|
from the admission of the patient in the operating room until the end of the surgery.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
August 1, 2015
Primary Completion (Actual)
December 1, 2016
Study Completion (Actual)
June 1, 2017
Study Registration Dates
First Submitted
March 6, 2016
First Submitted That Met QC Criteria
March 8, 2016
First Posted (Estimate)
March 14, 2016
Study Record Updates
Last Update Posted (Actual)
November 14, 2017
Last Update Submitted That Met QC Criteria
November 12, 2017
Last Verified
November 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CAAE: 44552315.1.0000.5505
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.
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