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Completed

NCT Number: NCT02707549

Fluid Therapy During Brain Tumor Resection in Children

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.

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Key information

Conditions

Brain Neoplasms Acid-Base Imbalance Brain Diseases Central Nervous System Diseases Central Nervous System Neoplasms Metabolic Diseases Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms Nutritional and Metabolic Diseases Water-Electrolyte Imbalance

Age range

6 month–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Federal University of Sao Paulo

São Paulo, 04023-062, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Drug

0.9% Sodium Chloride

Drug

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Federal University of São Paulo

Other

Registry information

Official study title

Comparison of Balanced Crystalloid Solution and 0,9% Sodium Chloride in Children Undergoing Brain Tumor Resection: a Randomized Controlled Trial

Important dates

Study start
2015
Primary completion
2016
Study completion
2017
First posted
Mar 14, 2016
Registry last updated
Nov 14, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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