Fluid Therapy During Brain Tumor Resection in Children

NCT ID: NCT02707549

Last Updated: 2017-11-14

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

53 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-31

Study Completion Date

2017-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Brain Neoplasms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

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.

Group Type ACTIVE_COMPARATOR

0.9% sodium chloride

Intervention Type DRUG

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.

Group Type EXPERIMENTAL

balanced crystalloid solution (components: sodium chloride, sodium gluconate, sodium acetate, potassium chloride and magnesium chloride)

Intervention Type DRUG

Interventions

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balanced crystalloid solution (components: sodium chloride, sodium gluconate, sodium acetate, potassium chloride and magnesium chloride)

Intervention Type DRUG

0.9% sodium chloride

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

6 Months

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Federal University of São Paulo

OTHER

Sponsor Role lead

Responsible Party

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Mariana Fontes Lima Neville

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Federal University of Sao Paulo

São Paulo, São Paulo, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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CAAE: 44552315.1.0000.5505

Identifier Type: -

Identifier Source: org_study_id

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