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

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

Status
Terminated
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00795587
Enrollment
3
Registered
2008-11-21
Start date
2008-10-31
Completion date
2011-08-31
Last updated
2012-11-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intracranial Hypertension, Traumatic Brain Injury

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

Interventions

DRUGvariation 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

Sponsors

University Hospital, Grenoble
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* impeding neurosurgery * hemodynamic or respiratory severe failure

Design outcomes

Primary

MeasureTime frame
intracranial pressure2 hours

Secondary

MeasureTime frame
brain PO22h
MAP2h
Heart Rate2h
transcranial doppler2 h
diuresis2h
fluid requirement2h
biology (blood gases, natremia, hematocrit)2h

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026