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| Name | Class |
|---|---|
| Sisters of Mercy University Hospital | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Normal saline fluid group | The patients in this group will receive 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Normal saline | Other | Plasma osmolality, acid base status and electrolytes after application up to 2000 ml of normal saline during neurosurgical operation |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma osmolality | Whether the applied fluids affect plasma osmolality | Immediately after operation |
Inclusion Criteria:
Exclusion Criteria:
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Patients who underwent neurosurgical procedure because of brain tumor, meningeoma and vascular malformation. And without signs of elevated intracranial pressure and any history of kidney or heart disease.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Natasa Kovac, M.D. | Contact | +38598296686 | natasakovac787@gmail.com | |
| Inga Mladic Batinica, M.D. | Contact | +385917811015 | ingamblue@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Natasa Kovac, M.D. | UHC Zagreb | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UHC Zgagreb | Recruiting | Zagreb | 10000 | Croatia |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D020785 | Central Nervous System Vascular Malformations |
| ID | Term |
|---|---|
| D009421 | Nervous System Malformations |
| D009422 | Nervous System Diseases |
| D054079 | Vascular Malformations |
| D018376 | Cardiovascular Abnormalities |
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| ID | Term |
|---|---|
| D000077330 | Saline Solution |
| C012499 | Plasma-lyte 148 |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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|
| Balanced fluid | Other | Plasma osmolality, acid base status and electrolytes after application of up to 2000 ml balanced fluids during neurosurgical operation |
|
|
| D002318 | Cardiovascular Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |