Hypertonic Saline 75% vs Mannitol 20%

This study has been completed.
Sponsor:
Information provided by:
Lawson Health Research Institute
ClinicalTrials.gov Identifier:
NCT00199511
First received: September 13, 2005
Last updated: June 21, 2007
Last verified: June 2007
  Purpose

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 Intervention
Brain Tumor
Tumor, Brain
Brain Neoplasm
Neoplasm, Supratentorial
Tumor, Supratentorial
Drug: Administration of Hypertonic Solution 7.5% vs Mannitol 20%

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:


Further study details as provided by Lawson Health Research Institute:

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.

Estimated Enrollment: 162
Study Start Date: January 2005
Study Completion Date: April 2007
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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00199511

Locations
Canada, Ontario
University Hospital LHSC
London, Ontario, Canada, N6A5A5
Sponsors and Collaborators
Lawson Health Research Institute
Investigators
Principal Investigator: Rosemary A Craen, MD Associate Proffesor UWO
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00199511     History of Changes
Other Study ID Numbers: R-05-154
Study First Received: September 13, 2005
Last Updated: June 21, 2007
Health Authority: Canada: Health Canada

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

Additional relevant MeSH terms:
Brain Neoplasms
Neoplasms
Supratentorial Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Mannitol
Pharmaceutical Solutions
Diuretics, Osmotic
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 01, 2014