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

Traumatic Brain Injury Clinical Trial

Official title:

Compared Effects of 2 Doses of Mannitol on Post Traumatic Intracranial Hypertension

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00795587
• Other study ID #: 0816
• Secondary ID: 2008-004979-21
• Status: Terminated
• Phase: Phase 4
• First received: November 20, 2008
• Last updated: November 7, 2012
• Start date: October 2008
• Est. completion date: August 2011

Study information

• Verified date: November 2012
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• adults

• severe traumatic brain injury

• intracranial hypertension requiring mannitol administration

Exclusion Criteria:

• impeding neurosurgery

• hemodynamic or respiratory severe failure

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension
• Intracranial Hypertension
• Traumatic Brain Injury

Intervention

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

Locations

Country	Name	City	State
France	Universitary Hospital	Grenoble

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	intracranial pressure		2 hours	Yes
Secondary	transcranial doppler		2 h	Yes
Secondary	brain PO2		2h	Yes
Secondary	MAP		2h	Yes
Secondary	Heart Rate		2h	Yes
Secondary	biology (blood gases, natremia, hematocrit)		2h	No
Secondary	diuresis		2h	Yes
Secondary	fluid requirement		2h	Yes