Skip to content

Normal Saline Vrs Balanced i.v. Fluids in Neurosurgery

Comparison of Normal Saline and Balanced Crystalloid Intravenous Therapy During Neurosurgery

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03429127
Enrollment
120
Registered
2018-02-12
Start date
2017-03-23
Completion date
2020-02-23
Last updated
2019-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Benign Neoplasms, Vascular Malformations, Brain

Keywords

balanced fluids, neurosurgery, plasma osmolality

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.

Interventions

OTHERNormal saline

Plasma osmolality, acid base status and electrolytes after application up to 2000 ml of normal saline during neurosurgical operation

OTHERBalanced fluid

Plasma osmolality, acid base status and electrolytes after application of up to 2000 ml balanced fluids during neurosurgical operation

Sponsors

Sisters of Mercy University Hospital
CollaboratorOTHER
Clinical Hospital Centre Zagreb
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Changes in acid base pH statusDuring operation and immediately after operationChanges in acid base pH status after each 500 ml of normal saline vrs. balanced fluid

Secondary

MeasureTime frameDescription
Changes in electrolytes (sodium and chloride)During operation and immediately after operationElectrolytes changes (sodium and chloride) after each 500 ml of normal saline vrs. balanced fluid

Other

MeasureTime frameDescription
Plasma osmolalityImmediately after operationWhether the applied fluids affect plasma osmolality

Countries

Croatia

Contacts

Primary ContactNatasa Kovac, M.D.
natasakovac787@gmail.com+38598296686
Backup ContactInga Mladic Batinica, M.D.
ingamblue@gmail.com+385917811015

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026