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Normal Saline Vrs Balanced i.v. Fluids in Neurosurgery

NCT ID: NCT03429127

Last Updated: 2019-04-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-03-23

Study Completion Date

2020-02-23

Brief Summary

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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.

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Detailed Description

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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

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Benign Neoplasms Vascular Malformations, Brain

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Normal saline fluid group

The patients in this group will receive up to 2000 ml of normal saline during neurosurgical operation.

Normal saline

Intervention Type OTHER

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

Balanced fluid group

The patients in this group will receive up to 2000 ml of balanced fluids during neurosurgical operation.

Balanced fluid

Intervention Type OTHER

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

Interventions

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Normal saline

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

Intervention Type OTHER

Balanced fluid

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

Intervention Type OTHER

Other Intervention Names

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0,9 % sodium chloride Plasma-Lyte 148

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sisters of Mercy University Hospital

OTHER

Sponsor Role collaborator

Clinical Hospital Centre Zagreb

OTHER

Sponsor Role lead

Responsible Party

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Natasa Kovac

Natasa Kovac, M.D., Anesthesiologyst and intensive care medicine subspecialist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Natasa Kovac, M.D.

Role: PRINCIPAL_INVESTIGATOR

UHC Zagreb

Locations

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UHC Zgagreb

Zagreb, , Croatia

Site Status RECRUITING

Countries

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Croatia

Central Contacts

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Natasa Kovac, M.D.

Role: CONTACT

[email protected]
+38598296686

Inga Mladic Batinica, M.D.

Role: CONTACT

[email protected]
+385917811015

Facility Contacts

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Natasa Kovac, M.D.

Role: primary

[email protected]
+38598296686

Inga Mladic Batinica, M.D.

Role: backup

[email protected]
+385917811015

Other Identifiers

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02/21 AG

Identifier Type: -

Identifier Source: org_study_id

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