Normal Saline Vrs Balanced i.v. Fluids in Neurosurgery
Comparison of Normal Saline and Balanced Crystalloid Intravenous Therapy During Neurosurgery
1 other identifier
observational
120
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Mar 2017
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 23, 2017
CompletedFirst Submitted
Initial submission to the registry
February 3, 2018
CompletedFirst Posted
Study publicly available on registry
February 12, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 23, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
February 23, 2020
CompletedApril 18, 2019
April 1, 2019
2.6 years
February 3, 2018
April 16, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
Changes in electrolytes (sodium and chloride)
During operation and immediately after operation
Other Outcomes (1)
Plasma osmolality
Immediately after operation
Study Arms (2)
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.
Interventions
Plasma osmolality, acid base status and electrolytes after application up to 2000 ml of normal saline during neurosurgical operation
Plasma osmolality, acid base status and electrolytes after application of up to 2000 ml balanced fluids during neurosurgical operation
Eligibility Criteria
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.
You may qualify if:
- Patients with brain tumor, meningeomas and vascular malformation.
You may not qualify if:
- Patients with signs of elevated intracranial pressure; History of kidney disease, History of heart disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UHC Zgagreb
Zagreb, 10000, Croatia
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Natasa Kovac, M.D.
UHC Zagreb
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Natasa Kovac, M.D., Anesthesiologyst and intensive care medicine subspecialist
Study Record Dates
First Submitted
February 3, 2018
First Posted
February 12, 2018
Study Start
March 23, 2017
Primary Completion
October 23, 2019
Study Completion
February 23, 2020
Last Updated
April 18, 2019
Record last verified: 2019-04
Data Sharing
- IPD Sharing
- Will not share