A Phase 2 interventional study of balanced crystalloid solution (components: sodium chloride, sodium gluconate, sodium acetate, potassium chloride and magnesium chloride) and 0.9% sodium chloride in Brain Neoplasms, sponsored by Federal University of São Paulo. Completed at 1 site in Brazil. Open to participants aged 6 Months to 12 Years. Per ClinicalTrials.gov, last updated 2017-11-14.
Sponsored by Federal University of São Paulo · Phase 2, Interventional, and Treatment
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.
1,960 studies on the registry are indexed under Brain Neoplasms; 516 are open to participants now.
This study's enrollment of 53 is above the median of 40 across 1,458 interventional studies indexed under Brain Neoplasms.
Browse Brain Neoplasms studies →Federal University of São Paulo is the lead sponsor of 427 studies on the registry; 22 are open to participants now.
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Exclusion Criteria:
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
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)
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.
Time frame: from the admission of the patient in the operating room until the end of the surgery.
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.
Time frame: from the end of the surgery until exactly 24 hours after the admission in intensive care unit (ICU)
brain relaxation score
Time frame: immediately after dura-mater opening
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.
Time frame: from the admission of the patient in the operating room until the end of the surgery.
This study is completed, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.
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Federal University of São Paulo