Clinical trial · Interventional
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
NCT02707549CI-TRIAL-00030337completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain Neoplasms | Brain Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 0.9% sodium chloride | Drug | — | UNRESOLVED |
| balanced crystalloid solution (components: sodium chloride, sodium gluconate, sodium acetate, potassium chloride and magnesium chloride) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Normal Saline Group
- description
- 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.
- interventionNames
- Drug: 0.9% sodium chloride
- type
- EXPERIMENTAL
- label
- Balanced Crystalloid Solution Group
- description
- the patients included in this group will receive balanced crystalloid solution during surgery and in the first 24 hours after ICU admission.
- interventionNames
- Drug: balanced crystalloid solution (components: sodium chloride, sodium gluconate, sodium acetate, potassium chloride and magnesium chloride)
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 6 Months
- Maximum age
- 12 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.