NCT02707549

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
53

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Aug 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2015

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

March 6, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 14, 2016

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

November 14, 2017

Status Verified

November 1, 2017

Enrollment Period

1.3 years

First QC Date

March 6, 2016

Last Update Submit

November 12, 2017

Conditions

Brain Neoplasms

Keywords

crystalloid solutionsacid-base imbalancewater-electrolyte Imbalance

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • serum chloride difference (mmol/L)

    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)

    from the admission of the patient in the operating room until the end of the surgery.

Study Arms (2)

Normal Saline Group

ACTIVE COMPARATOR

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

Balanced Crystalloid Solution Group

EXPERIMENTAL

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)

Interventions

balanced crystalloid solution (components: sodium chloride, sodium gluconate, sodium acetate, potassium chloride and magnesium chloride)DRUG
Balanced Crystalloid Solution Group
0.9% sodium chlorideDRUG
Normal Saline Group

Eligibility Criteria

Age6 Months - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • Uncontrolled Intracranial hypertension
  • Severe heart, kidney, or pulmonary disease
  • non-corrected electrolyte imbalance
  • allergy to the solution administered

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Federal University of Sao Paulo

São Paulo, São Paulo, 04023-062, Brazil

Location

MeSH Terms

Conditions

Brain NeoplasmsAcid-Base ImbalanceWater-Electrolyte Imbalance

Interventions

gluconic acidSodium AcetatePotassium ChlorideMagnesium ChlorideSodium Chloride

Condition Hierarchy (Ancestors)

Central Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Acetic AcidAcetatesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsPotassium CompoundsMagnesium CompoundsSodium Compounds

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 6, 2016

First Posted

March 14, 2016

Study Start

August 1, 2015

Primary Completion

December 1, 2016

Study Completion

June 1, 2017

Last Updated

November 14, 2017

Record last verified: 2017-11

Locations

BR(1)