Normal Saline Vrs Balanced i.v. Fluids in Neurosurgery

Study Overview
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Brief Summary
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The purpose of this study was to investigate whether the balanced fluids therapy change plasma osmolality in neurosurgical procedures due to brain tumors, meningeomas and arterio-venous malformation.

Detailed Description
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Normal saline or 0.9% sodium chloride solution is the most commonly used intravenous fluid worldwide and its composition are 154 mmol Na+ and 154 mmol Cl- per litter with osmolality of 308 mOsmol/L. That composition is not normal because plasma contains potassium in range between 137-146 mmol/L, and chloride in range between 98-106 mmol/L, with plasma osmolality of 280-295 mOsmol/kg. Recently published data suggested detrimental effects of chloride rich fluids on renal blood flow and glomerular filtration rate, urine output and acute kidney injury. One alternative to saline solution is a buffered, balanced, crystalloid solution with an electrolyte composition similar to plasma and osmolality between 286-295 mOsmol/L. Someone could indicate that such balanced solutions are not suitable for neurosurgical patients because of a possible impact on the brain edema development.

Official Title
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Comparison of Normal Saline and Balanced Crystalloid Intravenous Therapy During Neurosurgery

Conditions
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Benign Neoplasms, Vascular Malformations, Brain

Intervention / Treatment
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* Other: Normal saline
* Other: Balanced fluid


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with brain tumor, meningeomas and vascular malformation. Exclusion Criteria: Patients with signs of elevated intracranial pressure; History of kidney disease, History of heart disease

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Normal saline fluid group<br>The patients in this group will receive up to 2000 ml of normal saline during neurosurgical operation. | Other: Normal saline<br>* Plasma osmolality, acid base status and electrolytes after application up to 2000 ml of normal saline during neurosurgical operation<br>* Other names: 0,9 % sodium chloride;|
| Balanced fluid group<br>The patients in this group will receive up to 2000 ml of balanced fluids during neurosurgical operation. | Other: Balanced fluid<br>* Plasma osmolality, acid base status and electrolytes after application of up to 2000 ml balanced fluids during neurosurgical operation<br>* Other names: Plasma-Lyte 148;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in acid base pH status | Changes in acid base pH status after each 500 ml of normal saline vrs. balanced fluid | During operation and immediately after operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in electrolytes (sodium and chloride) | Electrolytes changes (sodium and chloride) after each 500 ml of normal saline vrs. balanced fluid | During operation and immediately after operation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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balanced fluids, neurosurgery, plasma osmolality