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

• Sponsor: University Hospital, Grenoble (Other)
• Overall Status: Terminated
• CT.gov ID: NCT00795587
• Collaborator: (none)
• Enrollment: 3
• Location: 1
• Arms: 2
• Duration (Months): 34
• Patients Per Site Per Month: 0.1

Study Details

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?

Condition or Disease	Intervention/Treatment	Phase
Traumatic Brain Injury; Intracranial Hypertension	Drug: variation of mannitol dose	Phase 4

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 3 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Compared Effects of 2 Doses of Mannitol on Post Traumatic Intracranial Hypertension
• Study Start Date: Oct 1, 2008
• Actual Primary Completion Date: Aug 1, 2011
• Actual Study Completion Date: Aug 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: mannitol high dose 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
Active Comparator: mannitol low dose 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

Outcome Measures

Primary Outcome Measures

1. intracranial pressure [2 hours]

Secondary Outcome Measures

1. transcranial doppler [2 h]

2. brain PO2 [2h]

3. MAP [2h]

4. Heart Rate [2h]

5. biology (blood gases, natremia, hematocrit) [2h]

6. diuresis [2h]

7. fluid requirement [2h]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• adults

• severe traumatic brain injury

• intracranial hypertension requiring mannitol administration

Exclusion Criteria:

• impeding neurosurgery

• hemodynamic or respiratory severe failure

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Universitary Hospital	Grenoble		France	38043

Sponsors and Collaborators

• University Hospital, Grenoble

Investigators

• Principal Investigator: Gilles Francony, MD, University Hospital, Grenoble

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University Hospital, Grenoble
• ClinicalTrials.gov Identifier: NCT00795587
• Other Study ID Numbers: 0816; 2008-004979-21
• First Posted: Nov 21, 2008
• Last Update Posted: Nov 8, 2012
• Last Verified: Nov 1, 2012

• Additional relevant MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Intracranial Hypertension; Hypertension; Mannitol

Study Results

No Results Posted as of Nov 8, 2012