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Hypertonic Saline 75% vs Mannitol 20%

Primary Purpose

Brain Tumor, Tumor, Brain, Brain Neoplasm

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Administration of Hypertonic Solution 7.5% vs Mannitol 20%
Sponsored by
Lawson Health Research Institute
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brain Tumor focused on measuring Brain Tumor, Intracranial Pressure, Osmolarity, Seric, Hypertonic Solution

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: ASA physical status I - 3. Age >18 years. Scheduled for elective craniotomies for supratentorial brain tumour resection. Written informed consent. Exclusion Criteria: Within the past six months, a history of unstable angina pectoris and/or having a myocardial infarction. Electrocardiogram abnormalities indicating severe ischemia. Congestive heart failure. Glasgow coma sore < 9 Refusal to participate or refusal to agree to randomization. Known renal failure Known poorly controlled diabetes.

Sites / Locations

  • University Hospital LHSC

Outcomes

Primary Outcome Measures

Surgeon's assessment of brain bulk.
ICP reduction

Secondary Outcome Measures

Changes in intracranial pressure
Changes in serum and urine levels of sodium, potassium and osmolarity.

Full Information

First Posted
September 13, 2005
Last Updated
November 2, 2018
Sponsor
Lawson Health Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT00199511
Brief Title
Hypertonic Saline 75% vs Mannitol 20%
Official Title
Comparison of Equiosmolar Doses of Mannitol 20% Versus Hypertonic Saline 7.5% Infusion in the Reduction of Brain Bulk During Elective Craniotomies for Supratentorial Brain Tumor Resection
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
January 2005 (Actual)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lawson Health Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to evaluate the effect of Hypertonic Saline 7.5% vs Mannitol 20% on brain bulk (using a 4 point scale), intracranial pressure (subdural catheter)and the changes on serum and urinary Na, K and Osmolarity during elective craniotomy for brain tumor resection.
Detailed Description
Raised intracranial pressure occurs following an expansion of an intracranial mass e.g. hematoma or brain tumor and if left untreated, can lead to brain ischemia, stroke and death. Strategies for reducing raised intracranial pressure include hyperventilation, use of a hyperosmolar agent and the evacuation of the intracranial mass. The two hypertonic solutions most commonly used are Mannitol 20% and Hypertonic Saline 7.5%. During elective neurosurgical removal of a brain tumour, the anesthesiologist needs to reduce intracranial pressure and provide good operating brain conditions to avoid brain ischemia. Currently, Mannitol 20% is routinely used intra-operatively in these patients to reduce brain bulk and intracranial pressure and to improve brain operating conditions. However, Mannitol itself can cause secondary effects that can be deleterious to the neurological patient. Mannitol causes a diuresis which may lead to systemic hypovolemia and hypotension, and adverse changes in serum and urinary sodium, potassium and osmolarity. Experience with Hypertonic saline 7.5%, has been mainly in brain injured patients either in the Emergency Dept or in the Intensive care setting. There is growing evidence that Hypertonic saline 7.5% is just as effective as Mannitol 20% in reducing raised intracranial pressure, especially in traumatic brain injury and it has become a widely accepted form of treatment. One of the advantages of Hypertonic saline is that it does not cause a diuresis and therefore less likely to cause hypotension and hypovolemia. While transient hypernatremia has been observed after the administration of hypertonic saline, there have been no clinical consequences. Unfortunately there have been only two studies which compared the effectiveness of Hypertonic saline and Mannitol during elective brain surgery. One of them, Gemma et al, failed to demonstrate any difference in the reduction of brain bulk between Mannitol and Hypertonic saline. However the 2 solutions used had different osmolarities and this may have had a confounding effect on the results. In the other study (published in Polish), the authors found a 20% reduction in brain bulk in favour of hypertonic saline. In view of these two opposing findings, we feel that another investigation is warranted.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Tumor, Tumor, Brain, Brain Neoplasm, Neoplasm, Supratentorial, Tumor, Supratentorial
Keywords
Brain Tumor, Intracranial Pressure, Osmolarity, Seric, Hypertonic Solution

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
162 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Administration of Hypertonic Solution 7.5% vs Mannitol 20%
Primary Outcome Measure Information:
Title
Surgeon's assessment of brain bulk.
Title
ICP reduction
Secondary Outcome Measure Information:
Title
Changes in intracranial pressure
Title
Changes in serum and urine levels of sodium, potassium and osmolarity.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ASA physical status I - 3. Age >18 years. Scheduled for elective craniotomies for supratentorial brain tumour resection. Written informed consent. Exclusion Criteria: Within the past six months, a history of unstable angina pectoris and/or having a myocardial infarction. Electrocardiogram abnormalities indicating severe ischemia. Congestive heart failure. Glasgow coma sore < 9 Refusal to participate or refusal to agree to randomization. Known renal failure Known poorly controlled diabetes.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rosemary A Craen, MD
Organizational Affiliation
Associate Proffesor UWO
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital LHSC
City
London
State/Province
Ontario
ZIP/Postal Code
N6A5A5
Country
Canada

12. IPD Sharing Statement

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Hypertonic Saline 75% vs Mannitol 20%

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