Normal Saline Vrs Balanced i.v. Fluids in Neurosurgery

Benign Neoplasms Clinical Trial

Official title:

Comparison of Normal Saline and Balanced Crystalloid Intravenous Therapy During Neurosurgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03429127
• Other study ID #: 02/21 AG
• Status: Recruiting
• Start date: March 23, 2017
• Est. completion date: February 23, 2020

Study information

• Verified date: April 2019
• Source: Clinical Hospital Centre Zagreb
• Contact: Natasa Kovac, M.D.
• Phone: +38598296686
• Email: natasakovac787[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: February 23, 2020
• Est. primary completion date: October 23, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Benign Neoplasms
• Congenital Abnormalities
• Neoplasms
• Vascular Malformations
• Vascular Malformations, Brain

Intervention

Other:
• Normal saline
Plasma osmolality, acid base status and electrolytes after application up to 2000 ml of normal saline during neurosurgical operation
• Balanced fluid
Plasma osmolality, acid base status and electrolytes after application of up to 2000 ml balanced fluids during neurosurgical operation

Locations

Country	Name	City	State
Croatia	UHC Zgagreb	Zagreb

Sponsors (2)

Lead Sponsor	Collaborator
Clinical Hospital Centre Zagreb	Sisters of Mercy University Hospital

Country where clinical trial is conducted

Croatia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Plasma osmolality	Whether the applied fluids affect plasma osmolality	Immediately after operation
Primary	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	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