Fluid Therapy During Brain Tumor Resection in Children

Study Overview
=================
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.

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

Conditions
-----------------
Brain Neoplasms

Intervention / Treatment
-----------------
* Drug: balanced crystalloid solution (components: sodium chloride, sodium gluconate, sodium acetate, potassium chloride and magnesium chloride)
* Drug: 0.9% sodium chloride


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 6 Months
Maximum Age: 12 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Normal Saline Group<br>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<br> <br> |
| Experimental: Balanced Crystalloid Solution Group<br>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)<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| serum chloride difference (mmol/L) | 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) | 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 |  | immediately after dura-mater opening | 
| serum sodium difference (mmol/L) | 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. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
crystalloid solutions, acid-base imbalance, water-electrolyte Imbalance