Fluid Therapy During Brain Tumor Resection in Children

Federal University of São Paulo

Status and phase: Completed; Phase 2

Conditions: Brain Neoplasms

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

Study type: Interventional

Funder types: Other

Identifiers

NCT02707549

CAAE: 44552315.1.0000.5505

Details and patient eligibility

About

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.

Enrollment: 53 patients

Sex: All

Ages: 6 months to 12 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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53 participants in 2 patient groups

Normal Saline Group

Active Comparator group

Description:

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.

Treatment:

Drug: 0.9% sodium chloride

Balanced Crystalloid Solution Group

Experimental group

Description:

the patients included in this group will receive balanced crystalloid solution during surgery and in the first 24 hours after ICU admission.

Treatment:

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