Normal Saline Vrs Balanced i.v. Fluids in Neurosurgery

• Conditions: Benign Neoplasms; Vascular Malformations, Brain
• Interventions: Other: Balanced fluid; Other: Normal saline

• Registration Number: NCT03429127
• Lead Sponsor: Clinical Hospital Centre Zagreb

Brief Summary

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

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.

Study Timeline

• Study Start: 2017-03-23
• Study First Submitted: 2018-02-03
• Study First Submitted QC: 2018-02-08
• Study First Posted: 2018-02-12
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-16
• Last Update Posted: 2019-04-18
• Primary Completion: 2019-10-23
• Study Completion: 2020-02-23

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Balanced fluid group	Balanced fluid	The patients in this group will receive up to 2000 ml of balanced fluids during neurosurgical operation.
Normal saline fluid group	Normal saline	The patients in this group will receive up to 2000 ml of normal saline during neurosurgical operation.

Primary Outcome Measures

Name	Time	Method
Changes in acid base pH status	During operation and immediately after operation	Changes in acid base pH status after each 500 ml of normal saline vrs. balanced fluid

Secondary Outcome Measures

Name	Time	Method
Changes in electrolytes (sodium and chloride)	During operation and immediately after operation	Electrolytes changes (sodium and chloride) after each 500 ml of normal saline vrs. balanced fluid

Trial Locations

Locations (1)

UHC Zgagreb; 🇭🇷 Zagreb, Croatia