Hypertonic Saline 75% vs Mannitol 20%

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00199511
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : June 25, 2007
Information provided by:
Lawson Health Research Institute

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.

Condition or disease Intervention/treatment Phase
Brain Tumor Tumor, Brain Brain Neoplasm Neoplasm, Supratentorial Tumor, Supratentorial Drug: Administration of Hypertonic Solution 7.5% vs Mannitol 20% Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Enrollment : 162 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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 Start Date : January 2005
Actual Study Completion Date : April 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Brain Tumors
Drug Information available for: Mannitol
U.S. FDA Resources

Primary Outcome Measures :
  1. Surgeon’s assessment of brain bulk.
  2. ICP reduction

Secondary Outcome Measures :
  1. Changes in intracranial pressure
  2. Changes in serum and urine levels of sodium, potassium and osmolarity.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00199511

Canada, Ontario
University Hospital LHSC
London, Ontario, Canada, N6A5A5
Sponsors and Collaborators
Lawson Health Research Institute
Principal Investigator: Rosemary A Craen, MD Associate Proffesor UWO Identifier: NCT00199511     History of Changes
Other Study ID Numbers: R-05-154
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: June 25, 2007
Last Verified: June 2007

Keywords provided by Lawson Health Research Institute:
Brain Tumor
Intracranial Pressure
Hypertonic Solution

Additional relevant MeSH terms:
Brain Neoplasms
Supratentorial Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Diuretics, Osmotic
Natriuretic Agents
Physiological Effects of Drugs