Normal Saline Vrs Balanced i.v. Fluids in Neurosurgery

Comparison of Normal Saline and Balanced Crystalloid Intravenous Therapy During Neurosurgery

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.

Study Overview

• Status: Unknown
• Conditions: Benign Neoplasms; Vascular Malformations, Brain
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Anticipated): 120

Contacts and Locations

• Study Contact: Name: Natasa Kovac, M.D.; Phone Number: +38598296686; Email: natasakovac787@gmail.com
• Study Contact Backup: Name: Inga Mladic Batinica, M.D.; Phone Number: +385917811015; Email: ingamblue@gmail.com

Study Locations

• Croatia
  • Zagreb, Croatia, 10000
    • Recruiting
    • UHC Zgagreb
    • Contact: Natasa Kovac, M.D.; Phone Number: +38598296686; Email: natasakovac787@gmail.com
    • Contact: Inga Mladic Batinica, M.D.; Phone Number: +385917811015; Email: ingamblue@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plasma osmolality	Whether the applied fluids affect plasma osmolality	Immediately after operation

Collaborators and Investigators

• Sponsor: Clinical Hospital Centre Zagreb
• Collaborators: Sisters of Mercy University Hospital
• Investigators: Principal Investigator: Natasa Kovac, M.D., UHC Zagreb

Study record dates

Study Major Dates

• Study Start (Actual): March 23, 2017
• Primary Completion (Anticipated): October 23, 2019
• Study Completion (Anticipated): February 23, 2020

Study Registration Dates

• First Submitted: February 3, 2018
• First Submitted That Met QC Criteria: February 8, 2018
• First Posted (Actual): February 12, 2018

Study Record Updates

• Last Update Posted (Actual): April 18, 2019
• Last Update Submitted That Met QC Criteria: April 16, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: balanced fluids, neurosurgery, plasma osmolality
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Nervous System Diseases; Congenital Abnormalities; Cardiovascular Abnormalities; Nervous System Malformations; Neoplasms; Vascular Malformations; Central Nervous System Vascular Malformations; Pharmaceutical Solutions; Ophthalmic Solutions; Plasma-lyte 148
• Other Study ID Numbers: 02/21 AG

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No