Mannitol Versus Hypertonic Saline Solution in the Treatment of Elevated Intracranial Pressure
Primary Purpose
Intracranial Hypertension
Status
Completed
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
20% mannitol
7.45% hypertonic saline solution
Sponsored by
About this trial
This is an interventional treatment trial for Intracranial Hypertension focused on measuring intracranial pressure, mannitol, hypertonic saline solution, brain injury, traumatic brain injury, Adult patients, With elevation of intracranial pressure (ICP > 20 mmHg)
Eligibility Criteria
Inclusion Criteria:
- age 18 or older
- sustained elevated intracranial pressure to more than 20 mmHg for more than 10 min
- mechanically ventilated in stable conditions for more than 2 hours prior to the study
- serum osmolality ranged between 280 and 320 mOsm/kg
Exclusion Criteria:
- imminent cranial or extracranial surgery
- leakage or drainage of cerebral spinal fluid
- unstable respiratory and hemodynamic conditions
- oliguric renal failure
- anemia
- use of mannitol or HSS in the previous 6 hours
- concomitant use of thiopentone
Sites / Locations
- Hopital Michallon
Outcomes
Primary Outcome Measures
Magnitude of ICP and of cerebral perfusion pressure (CPP) changes following osmotherapy during a study period of 120 min.
Secondary Outcome Measures
Effects of treatment on blood flow velocities (FV) of middle cerebral artery using continuous transcranial doppler.
Effects of treatment on brain oxygenation using brain tissue oxygen tension (PbrO2) probe.
Effects of treatment on biochemical data (serum sodium and osmolality, urine output).
Full Information
NCT ID
NCT00447018
First Posted
March 12, 2007
Last Updated
March 12, 2007
Sponsor
University Hospital, Grenoble
1. Study Identification
Unique Protocol Identification Number
NCT00447018
Brief Title
Mannitol Versus Hypertonic Saline Solution in the Treatment of Elevated Intracranial Pressure
Official Title
Equimolar Doses of Mannitol and Hypertonic Saline in the Treatment of Elevated Intracranial Pressure
Study Type
Interventional
2. Study Status
Record Verification Date
March 2007
Overall Recruitment Status
Completed
Study Start Date
October 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2005 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
University Hospital, Grenoble
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to determine whether mannitol is as effective as hypertonic saline solution in the treatment of elevated intracranial pressure in patients with brain injury.
Detailed Description
Elevation of intracranial pressure (ICP) to more than 20 mmHg plays a major role in the worsening of the neurological status through the impairment of brain perfusion. In an effort to reduce the intensity and the time spent with increased ICP, infusion of mannitol has been the recommended first-line agent for years. The growing interest in the use of hypertonic saline solutions (HSS) in this clinical setting has, however, challenged the use of mannitol. Because mannitol and HSS may differ regarding their clinically relevant mechanisms of action, there is a need to determine which osmotic compound could be the most appropriate in patients with elevated ICP. We conduct thus a parallel, randomized controlled trial comparing the effects of an equimolar infusion of 20% mannitol or 7.45% HSS without colloid in patients with elevated ICP. The primary end point of this trial is the magnitude of ICP and of cerebral perfusion pressure (CPP) changes following treatment during a study period of 120 min.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intracranial Hypertension
Keywords
intracranial pressure, mannitol, hypertonic saline solution, brain injury, traumatic brain injury, Adult patients, With elevation of intracranial pressure (ICP > 20 mmHg)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
20% mannitol
Intervention Type
Drug
Intervention Name(s)
7.45% hypertonic saline solution
Primary Outcome Measure Information:
Title
Magnitude of ICP and of cerebral perfusion pressure (CPP) changes following osmotherapy during a study period of 120 min.
Secondary Outcome Measure Information:
Title
Effects of treatment on blood flow velocities (FV) of middle cerebral artery using continuous transcranial doppler.
Title
Effects of treatment on brain oxygenation using brain tissue oxygen tension (PbrO2) probe.
Title
Effects of treatment on biochemical data (serum sodium and osmolality, urine output).
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
age 18 or older
sustained elevated intracranial pressure to more than 20 mmHg for more than 10 min
mechanically ventilated in stable conditions for more than 2 hours prior to the study
serum osmolality ranged between 280 and 320 mOsm/kg
Exclusion Criteria:
imminent cranial or extracranial surgery
leakage or drainage of cerebral spinal fluid
unstable respiratory and hemodynamic conditions
oliguric renal failure
anemia
use of mannitol or HSS in the previous 6 hours
concomitant use of thiopentone
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Francois Payen, MD, PhD
Organizational Affiliation
University Hospital, Grenoble
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hopital Michallon
City
Grenoble
ZIP/Postal Code
38043
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
15644669
Citation
Battison C, Andrews PJ, Graham C, Petty T. Randomized, controlled trial on the effect of a 20% mannitol solution and a 7.5% saline/6% dextran solution on increased intracranial pressure after brain injury. Crit Care Med. 2005 Jan;33(1):196-202; discussion 257-8. doi: 10.1097/01.ccm.0000150269.65485.a6.
Results Reference
result
PubMed Identifier
12794404
Citation
Vialet R, Albanese J, Thomachot L, Antonini F, Bourgouin A, Alliez B, Martin C. Isovolume hypertonic solutes (sodium chloride or mannitol) in the treatment of refractory posttraumatic intracranial hypertension: 2 mL/kg 7.5% saline is more effective than 2 mL/kg 20% mannitol. Crit Care Med. 2003 Jun;31(6):1683-7. doi: 10.1097/01.CCM.0000063268.91710.DF.
Results Reference
result
Learn more about this trial
Mannitol Versus Hypertonic Saline Solution in the Treatment of Elevated Intracranial Pressure
We'll reach out to this number within 24 hrs