Fluid Therapy During Brain Tumor Resection in Children

Phase 2

Completed

• Conditions: Brain Neoplasms
• Interventions: Drug: 0.9% sodium chloride

• Registration Number: NCT02707549
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-08
• Study First Submitted: 2016-03-06
• Study First Submitted QC: 2016-03-08
• Study First Posted: 2016-03-14
• Primary Completion: 2016-12
• Study Completion: 2017-06
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-12
• Last Update Posted: 2017-11-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 53

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Normal Saline Group	0.9% sodium chloride	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.

Primary Outcome Measures

Name	Time	Method
serum chloride difference (mmol/L)	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

Name	Time	Method
serum chloride difference (mmol/L)	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.
serum sodium difference (mmol/L)	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.
brain relaxation score	immediately after dura-mater opening

Trial Locations

Locations (1)

Federal University of Sao Paulo; 🇧🇷 Sao Paulo, SP, Brazil