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

Intervention / Treatment

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

  • Brazil
    • SP
      • Sao Paulo, SP, Brazil, 04023-062
        • Federal University of São Paulo

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.
Drug: 0.9% sodium chloride
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.
Drug: balanced crystalloid solution (components: sodium chloride, sodium gluconate, sodium acetate, potassium chloride and magnesium chloride)

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

Federal University of São Paulo

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

Keywords

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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