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ISRCTN
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ISRCTN62699180
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ClinicalTrials.gov identifier
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Public title
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Efficiency of 7.2% hypertonic saline hydroxyethyl starch 200/0.5 versus mannitol 15% in the treatment of increased intracranial pressure in neurosurgical patients
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Scientific title
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Acronym
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N/A
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Serial number at source
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N/A
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Study hypothesis
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Severe brain injury can lead to a brain edema with increased intracranial pressure. This fact leads to a reduced cerebral blood flow and cerebral oxygenation. These situations can extend the brain edema with a possible poor patient outcome.
7.2% hypertonic saline hydroxyethyl starch 200/0.5 is more effective compared to mannitol 15% in the treatment of increased intracranial pressure in neurosurgical patients.
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Lay summary
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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Germany
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Disease/condition/study domain
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Increased intracranial pressure
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Participants - inclusion criteria
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1. Neurosurgical patients >18 years with severe neuronal damage being at risk of increased intracranial pressure (ICP)
2. Cerebral edema - visualized by computed tomography (CT) scan, continuous monitoring of ICP
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Participants - exclusion criteria
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Exclusion criteria were elevated ICP due to space occupying lesions with indication for neurosurgical intervention, severe renal failure, metabolic disorders, initial serum sodium >150 mmol/l and initial serum osmolarity >320 mosm/kg
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Anticipated start date
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01/02/2003
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Anticipated end date
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31/08/2004
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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40
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Interventions
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Cerebral perfusion pressure (CPP) directed therapy with CPP >70 mmHg, sedation, normoventilation.
If ICP >20 mmHg patients receive either 7.2% hydroxyethyl starch 200/0.5 or mannitol 15%.
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Primary outcome measure(s)
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ICP <15 mmHg
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Secondary outcome measure(s)
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Survival, discharge status
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Sources of funding
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Self-funded trial, Department of Anesthesia and Critical Care, Martin-Luther University Halle (Germany)
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Trial website
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Publications
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Results: http://www.ncbi.nlm.nih.gov/pubmed/16277715
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Contact name
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Dr
Jens
Soukup
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Address
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Martin-Luther-University Halle
Department of Anaesthesia and Critical Care
Klinikum Kröllwitz
Ernst-Grube-Str. 40
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City/town
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Halle
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Zip/Postcode
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06097
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Country
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Germany
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Tel
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+49 345 5575992
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Fax
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+49 345 5574636
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Email
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jens.soukup@medizin.uni-halle.de
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Sponsor
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Martin-Luther-University Halle - Department of Anesthesia and Critical Care (Germany)
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Address
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Klinikum Kröllwitz
Ernst-Grube-Str. 40
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City/town
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Halle
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Zip/Postcode
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06097
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Country
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Germany
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Tel
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+49 345 5575992
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Fax
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+49 345 5574636
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Email
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jens.soukup@medizin.uni-halle.de
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Sponsor website:
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http://www.experimentelle-anaesthesie.de
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Date applied
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23/06/2005
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Last edited
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15/04/2008
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Date ISRCTN assigned
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24/06/2005
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