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ISRCTN
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ISRCTN82121210
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ClinicalTrials.gov identifier
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Public title
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A Pilot Study of the Effect of a Hypertonic Saline/Dextran (HSD) Solution Compared to Mannitol in the Management of Raised Intracranial Pressure (ICP)
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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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N0185139336
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Study hypothesis
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Whether hypertonic saline/dextran produces greater lowering of raised intracranial pressure and for a longer duration that an equiosmolar dose of mannitol.
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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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United Kingdom
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Disease/condition/study domain
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Injury, Occupational Diseases, Poisoning: Brain
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Participants - inclusion criteria
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Not provided at time of registration
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Participants - exclusion criteria
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Not provided at time of registration
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Anticipated start date
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01/11/2001
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Anticipated end date
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31/12/2004
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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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Not provided at time of registration
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Interventions
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Patients on the intensive care unit with brain injury and an intracranial monitor fitted will be eligible for entry into the study. Those with persistently elevated ICP despite usual management will be randomised to receive either mannitol 0.25 g/kg (the standard treatment at this point) or an equiosmolar dose of HSD. ICP will be recorded each minute using the standard ICU monitors. Patients will be eligible to receive up to three doses of the drug (Mannitol or HSD) if their clinical condition warrants it and there are no contra-indications. ICP will be monitored, for the purposes of the study, until eight hours since the last dose of HSD/mannitol.
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Primary outcome measure(s)
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Not provided at time of registration
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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Plymouth Hospitals NHS Trust
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Trial website
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Publications
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Contact name
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Dr
P D
Macnaughton
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Address
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Intensive Care Unit,
Level 04
Derriford Hospital
Derriford
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City/town
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Plymouth
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Zip/Postcode
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PL6 8DH
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Country
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United Kingdom
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Tel
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+44 (0)1752 792555
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Fax
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+44 (0)1752 763287
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Email
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peter.macnaughton@phnt.swest.nhs.uk
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Sponsor
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Record Provided by the NHSTCT Register - 2004 Update - Department of Health (UK)
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Address
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The Department of Health, Richmond House, 79 Whitehall
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City/town
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London
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Zip/Postcode
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SW1A 2NL
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Country
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United Kingdom
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Tel
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+44 (0)20 7307 2622
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Email
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dhmail@doh.gsi.org.uk
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Sponsor website:
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http://www.dh.gov.uk/Home/fs/en
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Date applied
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30/09/2004
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Last edited
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03/01/2006
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Date ISRCTN assigned
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30/09/2004
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