Clinical Trials Directory

Trials / Unknown

UnknownNCT03429127

Normal Saline Vrs Balanced i.v. Fluids in Neurosurgery

Comparison of Normal Saline and Balanced Crystalloid Intravenous Therapy During Neurosurgery

Status
Unknown
Phase
Study type
Observational
Enrollment
120 (estimated)
Sponsor
Clinical Hospital Centre Zagreb · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERNormal salinePlasma osmolality, acid base status and electrolytes after application up to 2000 ml of normal saline during neurosurgical operation
OTHERBalanced fluidPlasma osmolality, acid base status and electrolytes after application of up to 2000 ml balanced fluids during neurosurgical operation

Timeline

Start date
2017-03-23
Primary completion
2019-10-23
Completion
2020-02-23
First posted
2018-02-12
Last updated
2019-04-18

Locations

1 site across 1 country: Croatia

Source: ClinicalTrials.gov record NCT03429127. Inclusion in this directory is not an endorsement.