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Fluid Therapy During Brain Tumor Resection in Children

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ClinicalTrials.gov Identifier: NCT02707549
Recruitment Status : Completed
First Posted : March 14, 2016
Last Update Posted : November 14, 2017
Sponsor:
Information provided by (Responsible Party):
Mariana Fontes Lima Neville, Federal University of São Paulo

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.

Condition or disease Intervention/treatment Phase
Brain Neoplasms Drug: balanced crystalloid solution (components: sodium chloride, sodium gluconate, sodium acetate, potassium chloride and magnesium chloride) Drug: 0.9% sodium chloride Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 53 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Balanced Crystalloid Solution and 0,9% Sodium Chloride in Children Undergoing Brain Tumor Resection: a Randomized Controlled Trial
Actual Study Start Date : August 2015
Actual Primary Completion Date : December 2016
Actual Study Completion Date : June 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Brain Tumors

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)



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. brain relaxation score [ Time Frame: immediately after dura-mater opening ]
  3. 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.



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Ages Eligible for Study:   6 Months to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02707549


Locations
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Brazil
Federal University of Sao Paulo
Sao Paulo, SP, Brazil, 04023-062
Sponsors and Collaborators
Federal University of São Paulo

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Responsible Party: Mariana Fontes Lima Neville, Principal Investigator, Federal University of São Paulo
ClinicalTrials.gov Identifier: NCT02707549     History of Changes
Other Study ID Numbers: CAAE: 44552315.1.0000.5505
First Posted: March 14, 2016    Key Record Dates
Last Update Posted: November 14, 2017
Last Verified: November 2017
Keywords provided by Mariana Fontes Lima Neville, Federal University of São Paulo:
crystalloid solutions
acid-base imbalance
water-electrolyte Imbalance
Additional relevant MeSH terms:
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Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Pharmaceutical Solutions