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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


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
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