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
| Type | Name | Description |
|---|---|---|
| OTHER | Normal saline | Plasma osmolality, acid base status and electrolytes after application up to 2000 ml of normal saline during neurosurgical operation |
| OTHER | Balanced fluid | Plasma 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.