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Comparison of 2 Doses of Mannitol on Post Traumatic Intracranial Hypertension and Cerebral Monitoring

Primary Purpose

Traumatic Brain Injury, Intracranial Hypertension

Status
Terminated
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
variation of mannitol dose
Sponsored by
University Hospital, Grenoble
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Traumatic Brain Injury

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • adults
  • severe traumatic brain injury
  • intracranial hypertension requiring mannitol administration

Exclusion Criteria:

  • impeding neurosurgery
  • hemodynamic or respiratory severe failure

Sites / Locations

  • Universitary Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

mannitol high dose

mannitol low dose

Arm Description

mannitol 20% 0,8 g/ kg on minutes

mannitol 20% 0,4 g/ kg on minutes

Outcomes

Primary Outcome Measures

intracranial pressure

Secondary Outcome Measures

transcranial doppler
brain PO2
MAP
Heart Rate
biology (blood gases, natremia, hematocrit)
diuresis
fluid requirement

Full Information

First Posted
November 20, 2008
Last Updated
November 7, 2012
Sponsor
University Hospital, Grenoble
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1. Study Identification

Unique Protocol Identification Number
NCT00795587
Brief Title
Comparison of 2 Doses of Mannitol on Post Traumatic Intracranial Hypertension and Cerebral Monitoring
Official Title
Compared Effects of 2 Doses of Mannitol on Post Traumatic Intracranial Hypertension
Study Type
Interventional

2. Study Status

Record Verification Date
November 2012
Overall Recruitment Status
Terminated
Why Stopped
evolution of patient's care allows no more recruitment
Study Start Date
October 2008 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
August 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Grenoble

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Will an increase of the dose of mannitol improve the effects on neuromonitoring in patients suffering intracranial hypertension following traumatic brain injury?
Detailed Description
traumatic brain injury intracranial hypertension 0,4 g/ kg vs 0,8 g/ kg (randomized) on 20 minutes monitoring: ICP, transcranial doppler, brain pO2, MAP, HR, diuresis, biology duration: 2 hours

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Brain Injury, Intracranial Hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Arm Title
mannitol high dose
Arm Type
Active Comparator
Arm Description
mannitol 20% 0,8 g/ kg on minutes
Arm Title
mannitol low dose
Arm Type
Active Comparator
Arm Description
mannitol 20% 0,4 g/ kg on minutes
Intervention Type
Drug
Intervention Name(s)
variation of mannitol dose
Intervention Description
in case of intracranial hypertension up to 20 mmHg lasting more than 10 minutes and without nociceptive stimulation or systemic instability: injection of either 0.4 g/ kg or 0.8 g/ kg of mannitol 20% (randomized) on 20 minutes, with monitoring of neurologic, systemic and biologic datas during 120 minutes
Primary Outcome Measure Information:
Title
intracranial pressure
Time Frame
2 hours
Secondary Outcome Measure Information:
Title
transcranial doppler
Time Frame
2 h
Title
brain PO2
Time Frame
2h
Title
MAP
Time Frame
2h
Title
Heart Rate
Time Frame
2h
Title
biology (blood gases, natremia, hematocrit)
Time Frame
2h
Title
diuresis
Time Frame
2h
Title
fluid requirement
Time Frame
2h

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: adults severe traumatic brain injury intracranial hypertension requiring mannitol administration Exclusion Criteria: impeding neurosurgery hemodynamic or respiratory severe failure
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gilles Francony, MD
Organizational Affiliation
University Hospital, Grenoble
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universitary Hospital
City
Grenoble
ZIP/Postal Code
38043
Country
France

12. IPD Sharing Statement

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Comparison of 2 Doses of Mannitol on Post Traumatic Intracranial Hypertension and Cerebral Monitoring

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