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Normal Saline Vrs Balanced i.v. Fluids in Neurosurgery

C

Clinical Hospital Centre Zagreb

Status

Unknown

Conditions

Benign Neoplasms
Vascular Malformations, Brain

Treatments

Other: Normal saline
Other: Balanced fluid

Study type

Observational

Funder types

Other

Identifiers

NCT03429127
02/21 AG

Details and patient eligibility

About

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.

Full 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.

Enrollment

120 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

120 participants in 2 patient groups

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

Trial contacts and locations

1

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Central trial contact

Natasa Kovac, M.D.; Inga Mladic Batinica, M.D.

Data sourced from clinicaltrials.gov

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