A Comparison of the Effect of 1.5 Versus 3% NaCl on Brain Relaxation and Microcirculation
Primary Purpose
Brain Tumors
Status
Completed
Phase
Not Applicable
Locations
Czechia
Study Type
Interventional
Intervention
1.5% NaCl
3% NaCl
Sponsored by
About this trial
This is an interventional treatment trial for Brain Tumors focused on measuring Brain Tumors, Microcirculation, Osmotherapy, Hypertonic NaCl, Natremia
Eligibility Criteria
Inclusion Criteria:
- peripheral supratentorial brain tumors or metastasis
- indication for osmotherapy
- ASA status I-III
Exclusion Criteria:
- reoperation
- osmotherapy prior to surgery
- preoperative natremia less than 135 mmol/l and more than 140 mmol/l
- GCS less than 14
- obstructive hydrocephalus
Sites / Locations
- University Hospital Hradec Kralove
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
1.5% NaCl
3% NaCl
Arm Description
After standardized induction to general anesthesia group A patients will be given the infusion of hyperosmotic 1.5% NaCl 5 ml/kg/BW during 15 min.
After standardized induction to general anesthesia group B patients will be given the infusion of hyperosmotic 3% NaCl 5 ml/kg/BW during 15 min.
Outcomes
Primary Outcome Measures
Changes in brain microcirculation
measurement by SDF probe MicroVision
Secondary Outcome Measures
Changes in natremia
mmol/l
Changes in natremia
mmol/l
Changes in osmolarity
mosm/l
Changes in osmolarity
mosm/l
Concentration of natrium in cerebrospinal fluid
mmol/l
Full Information
NCT ID
NCT02537106
First Posted
August 27, 2015
Last Updated
September 28, 2019
Sponsor
University Hospital Hradec Kralove
1. Study Identification
Unique Protocol Identification Number
NCT02537106
Brief Title
A Comparison of the Effect of 1.5 Versus 3% NaCl on Brain Relaxation and Microcirculation
Official Title
A Comparison of the Effect of 1.5% Versus 3% NaCl on Brain Relaxation and Microcirculation During the Supratentorial Brain Tumor Surgery, and Natremia and Osmolarity in Postoperative Period
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
September 2015 (undefined)
Primary Completion Date
March 2019 (Actual)
Study Completion Date
May 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital Hradec Kralove
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Hyperosmotic solutions of 1.5% and 3% NaCl are equally effective for brain relaxation and microcirculation during brain surgery. The effect of 1.5% NaCl on postoperative natremia and natriuresis is less pronounced.
Detailed Description
All the patients meeting the study criteria will be randomized into two groups. After standardized induction to general anesthesia all patients will be given the infusion of hyperosmotic NaCl 5 ml/kg/BW during 30 min, group A 1.5% NaCl, group B 3% NaCl. Corticosteroids will be administered as usually. After dura opening the brain relaxation score will be assessed by surgeon (1 = completely relaxed, 2 = satisfactorily relaxed, 3 = firm brain, 4 = bulging brain), and the first measurement of the brain microcirculation provided by use of SDF probe in the area of the healthy brain, and of perifocal oedema. Both sites of investigation will be marked for the second measurement, which will be done after the end of tumor resection. Laboratory examinations: natremia preoperatively, natremia and osmolarity peroperatively 1 hour after NaCl infusion and at the end of surgery. Concentration of natrium will be examined in CSF after dura opening. Anesthesia management will be according to the standardised protocol, the patients will be awaken and extubated after the end of the procedure at the operating theatre.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Tumors
Keywords
Brain Tumors, Microcirculation, Osmotherapy, Hypertonic NaCl, Natremia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1.5% NaCl
Arm Type
Experimental
Arm Description
After standardized induction to general anesthesia group A patients will be given the infusion of hyperosmotic 1.5% NaCl 5 ml/kg/BW during 15 min.
Arm Title
3% NaCl
Arm Type
Experimental
Arm Description
After standardized induction to general anesthesia group B patients will be given the infusion of hyperosmotic 3% NaCl 5 ml/kg/BW during 15 min.
Intervention Type
Procedure
Intervention Name(s)
1.5% NaCl
Intervention Description
After the infusion of 1.5% NaCl and dura opening the microcirculation and the brain relaxation score will be measured in the area of healthy brain and perifocal oedema sites. Microcirculation measurement will be repeated at the same sites after tumor resection.
Intervention Type
Procedure
Intervention Name(s)
3% NaCl
Intervention Description
After the infusion of 3% NaCl and dura opening the microcirculation and the brain relaxation score will be measured in the area of healthy brain and perifocal oedema sites. Microcirculation measurement will be repeated at the same sites after tumor resection.
Primary Outcome Measure Information:
Title
Changes in brain microcirculation
Description
measurement by SDF probe MicroVision
Time Frame
from dura opening till the end of tumor resection
Secondary Outcome Measure Information:
Title
Changes in natremia
Description
mmol/l
Time Frame
1 hour after hypertonic NaCl infusion
Title
Changes in natremia
Description
mmol/l
Time Frame
5 min after the end of surgery
Title
Changes in osmolarity
Description
mosm/l
Time Frame
1 hour after hypertonic NaCl infusion
Title
Changes in osmolarity
Description
mosm/l
Time Frame
5 min after the end of surgery
Title
Concentration of natrium in cerebrospinal fluid
Description
mmol/l
Time Frame
after dura opening
Other Pre-specified Outcome Measures:
Title
Changes in diuresis
Description
ml/hour
Time Frame
at the time of extubation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
peripheral supratentorial brain tumors or metastasis
indication for osmotherapy
ASA status I-III
Exclusion Criteria:
reoperation
osmotherapy prior to surgery
preoperative natremia less than 135 mmol/l and more than 140 mmol/l
GCS less than 14
obstructive hydrocephalus
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vlasta Dostalova, MD.
Organizational Affiliation
University Hospital Hradec Kralove
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Hradec Kralove
City
Hradec Kralove
ZIP/Postal Code
50005
Country
Czechia
12. IPD Sharing Statement
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A Comparison of the Effect of 1.5 Versus 3% NaCl on Brain Relaxation and Microcirculation
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