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Normal Saline Vrs Balanced i.v. Fluids in Neurosurgery

Sponsor
Clinical Hospital Centre Zagreb (Other)
Overall Status
Unknown status
CT.gov ID
NCT03429127
Collaborator
Sisters of Mercy University Hospital (Other)
120
Enrollment
1
Location
35.1
Anticipated Duration (Months)
3.4
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Other: Normal saline
  • Other: Balanced fluid

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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
120 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Comparison of Normal Saline and Balanced Crystalloid Intravenous Therapy During Neurosurgery
Actual Study Start Date :
Mar 23, 2017
Anticipated Primary Completion Date :
Oct 23, 2019
Anticipated Study Completion Date :
Feb 23, 2020

Arms and Interventions

Arm Intervention/Treatment
Normal saline fluid group

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

Other: Normal saline
Plasma osmolality, acid base status and electrolytes after application up to 2000 ml of normal saline during neurosurgical operation
Other Names:
  • 0,9 % sodium chloride

    		•
    Balanced fluid group

    The patients in this group will receive up to 2000 ml of balanced fluids 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
    Other Names:
  • Plasma-Lyte 148

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Changes in acid base pH status [During operation and immediately after operation]

      Changes in acid base pH status after each 500 ml of normal saline vrs. balanced fluid

    Secondary Outcome Measures

    1. Changes in electrolytes (sodium and chloride) [During operation and immediately after operation]

      Electrolytes changes (sodium and chloride) after each 500 ml of normal saline vrs. balanced fluid

    Other Outcome Measures

    1. Plasma osmolality [Immediately after operation]

      Whether the applied fluids affect plasma osmolality

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 UHC Zgagreb Zagreb Croatia 10000

    Sponsors and Collaborators

    • Clinical Hospital Centre Zagreb
    • Sisters of Mercy University Hospital

    Investigators

    • Principal Investigator: Natasa Kovac, M.D., UHC Zagreb

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Natasa Kovac, Natasa Kovac, M.D., Anesthesiologyst and intensive care medicine subspecialist, Clinical Hospital Centre Zagreb
    ClinicalTrials.gov Identifier:
    NCT03429127
    Other Study ID Numbers:
    • 02/21 AG
    First Posted:
    Feb 12, 2018
    Last Update Posted:
    Apr 18, 2019
    Last Verified:
    Apr 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Natasa Kovac, Natasa Kovac, M.D., Anesthesiologyst and intensive care medicine subspecialist, Clinical Hospital Centre Zagreb
    balanced fluids, neurosurgery, plasma osmolality
    Additional relevant MeSH terms:
    Neoplasms
    Central Nervous System Vascular Malformations
    Vascular Malformations
    Plasma-lyte 148

    Study Results

    No Results Posted as of Apr 18, 2019