Comparison of 2 Doses of Mannitol on Post Traumatic Intracranial Hypertension and Cerebral Monitoring - Full Text View

Sponsored by:	University Hospital, Grenoble
Information provided by:	University Hospital, Grenoble
ClinicalTrials.gov Identifier:	NCT00795587

Purpose

Will an increase of the dose of mannitol improve the effects on neuromonitoring in patients suffering intracranial hypertension following traumatic brain injury?

Condition	Intervention	Phase
Traumatic Brain Injury Intracranial Hypertension	Drug: variation of mannitol dose	Phase IV

MedlinePlus related topics: High Blood Pressure Traumatic Brain Injury

Drug Information available for: Mannitol

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Compared Effects of 2 Doses of Mannitol on Post Traumatic Intracranial Hypertension

Further study details as provided by University Hospital, Grenoble:

Primary Outcome Measures:

intracranial pressure [ Time Frame: 2 hours ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

transcranial doppler [ Time Frame: 2 h ] [ Designated as safety issue: Yes ]
brain PO2 [ Time Frame: 2h ] [ Designated as safety issue: Yes ]
MAP [ Time Frame: 2h ] [ Designated as safety issue: Yes ]
Heart Rate [ Time Frame: 2h ] [ Designated as safety issue: Yes ]
biology (blood gases, natremia, hematocrit) [ Time Frame: 2h ] [ Designated as safety issue: No ]
diuresis [ Time Frame: 2h ] [ Designated as safety issue: Yes ]
fluid requirement [ Time Frame: 2h ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	24
Study Start Date:	October 2008
Estimated Study Completion Date:	October 2010
Estimated Primary Completion Date:	October 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
mannitol high dose: Active Comparator mannitol 20% 0,8 g/ kg on minutes	Drug: variation of mannitol dose 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
mannitol low dose: Active Comparator mannitol 20% 0,4 g/ kg on minutes	Drug: variation of mannitol dose 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

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

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

adults
severe traumatic brain injury
intracranial hypertension requiring mannitol administration

Exclusion Criteria:

impeding neurosurgery
hemodynamic or respiratory severe failure

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00795587

Contacts

Contact: Gilles FRANCONY, MD

04 76 76 72 83 ext 00 33

GFrancony@chu-grenoble.fr

Locations

France
Universitary Hospital	Recruiting
Grenoble, France, 38043
Contact: Gilles FRANCONY, MD 04 76 76 72 83 ext 00 33 GFrancony@chu-grenoble.fr
Principal Investigator: Gilles FRANCONY, MD
Sub-Investigator: Jean François PAYEN, MD PhD
Sub-Investigator: Samuel GAY, resident

Sponsors and Collaborators

University Hospital, Grenoble

Investigators

Principal Investigator:

Gilles Francony, MD

University Hospital, Grenoble

More Information

Responsible Party:	Grenoble University Hospital ( Dr Gilles FRANCONY )
Study ID Numbers:	0816, 2008--004979-21
Study First Received:	November 20, 2008
Last Updated:	November 20, 2008
ClinicalTrials.gov Identifier:	NCT00795587
Health Authority:	France: Afssaps - French Health Products Safety Agency

Study placed in the following topic categories:

Craniocerebral Trauma
Pseudotumor Cerebri
Vascular Diseases
Wounds and Injuries
Central Nervous System Diseases
Disorders of Environmental Origin
Trauma, Nervous System

Brain Diseases
Intracranial Hypertension
Pseudotumor cerebri
Mannitol
Brain Injuries
Hypertension

Additional relevant MeSH terms:

Natriuretic Agents
Therapeutic Uses
Diuretics, Osmotic
Physiological Effects of Drugs
Diuretics

Nervous System Diseases
Cardiovascular Diseases
Cardiovascular Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009