Fluid Therapy During Brain Tumor Resection in Children

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02707549

Enrollment

Registered

2016-03-14

Start date

2015-08-31

Completion date

2017-06-30

Last updated

2017-11-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain Neoplasms

Keywords

crystalloid solutions, acid-base imbalance, water-electrolyte Imbalance

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.

Interventions

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

DRUG0.9% sodium chloride

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

6 Months to 12 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.
brain relaxation score	immediately after dura-mater opening	—
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.

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026