NCT00199511

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
162

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2005

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2007

Completed
Last Updated

November 6, 2018

Status Verified

November 1, 2018

First QC Date

September 13, 2005

Last Update Submit

November 2, 2018

Conditions

Brain TumorTumor, BrainBrain NeoplasmNeoplasm, SupratentorialTumor, Supratentorial

Keywords

Brain TumorIntracranial PressureOsmolaritySericHypertonic Solution

Outcome Measures

Primary Outcomes (2)

  • Surgeon's assessment of brain bulk.

  • ICP reduction

Secondary Outcomes (2)

  • Changes in intracranial pressure

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

Interventions

Administration of Hypertonic Solution 7.5% vs Mannitol 20%DRUG

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ASA physical status I - 3.
  • Age \>18 years.
  • Scheduled for elective craniotomies for supratentorial brain tumour resection.
  • Written informed consent.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital LHSC

London, Ontario, N6A5A5, Canada

Location

MeSH Terms

Conditions

Brain NeoplasmsSupratentorial Neoplasms

Condition Hierarchy (Ancestors)

Central Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Rosemary A Craen, MD

    Associate Proffesor UWO

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 20, 2005

Study Start

January 1, 2005

Study Completion

April 1, 2007

Last Updated

November 6, 2018

Record last verified: 2018-11

Locations

CA(1)