Fluid Therapy During Brain Tumor Resection in Children

Brain Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02707549
• Other study ID #: CAAE: 44552315.1.0000.5505
• Status: Completed
• Phase: Phase 2
• First received: March 6, 2016
• Last updated: November 12, 2017
• Start date: August 2015
• Est. completion date: June 2017

Study information

• Verified date: November 2017
• Source: Federal University of São Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: June 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Neoplasms

Intervention

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

• 0.9% sodium chloride

Locations

Country	Name	City	State
Brazil	Federal University of Sao Paulo	Sao Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	brain relaxation score		immediately after dura-mater opening
Secondary	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.