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ISRCTN
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ISRCTN19958964
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ClinicalTrials.gov identifier
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Public title
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An assessment of the effects of altering blood pressure on cerebral and systemic haemodynamics in patients with acute ischaemic stroke
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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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To assess the effects of altering blood pressure on cerebral and systemic haemodynamics in patients with acute ischaemic stroke.
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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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United Kingdom
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Disease/condition/study domain
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Ischaemic Stroke
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Participants - inclusion criteria
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1. Patients of either sex ≥18 years
2. Proven ischaemic stroke on computed tomography (CT)
3. Stroke onset within 96 hours
4. Written informed consent
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Participants - exclusion criteria
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1. Non-ischaemic stroke
2. Unconscious or Scandinavian Neurological Stroke Scale (SNSS) conscious level <4
3. Baseline systolic blood pressure (BP) >180 mmHg or <100 mmHg
4. Baseline diastolic BP >110 mmHg or <60 mmHg
5. Women of childbearing potential/pregnant/lactating
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Anticipated start date
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01/01/2000
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Anticipated end date
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01/01/2007
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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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24
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Interventions
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Patients will be randomised to receive intravenous dobutamine or normal saline alone. Dobutamine will be administered at increasing concentrations at 5 minute intervals. Measurements using transcranial doppler, pulse wave analysis and venous blood samples will be taken at baseline and at each 5 minute dose increment.
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Primary outcome measure(s)
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The ability of dobutamine to reduce systolic, diastolic and mean arterial BP. Safety and tolerability of dobutamine in acute ischaemic stroke.
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Secondary outcome measure(s)
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90 day modified Rankin, Barthel and mortality.
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Sources of funding
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University of Nottingham (UK) - Division of Stroke Medicine
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Trial website
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Publications
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Contact name
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Prof
Philip
Bath
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Address
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Division of Stroke Medicine
Clinical Sciences Building
City Hospital Campus
Hucknall Road
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City/town
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Nottingham
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Zip/Postcode
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NG5 1PB
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Country
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United Kingdom
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Tel
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+44 (0)115 840 4792
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Email
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philip.bath@nottingham.ac.uk
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Sponsor
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University of Nottingham (UK)
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Address
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Clinical Sciences Building
City Hospital Campus
Hucknall Road
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City/town
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Nottingham
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Zip/Postcode
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NG5 1PB
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Country
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United Kingdom
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Tel
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+44 (0)115 840 4791
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Fax
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+44 (0)115 840 4790
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Email
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phillip.bath@nottingham.ac.uk
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Date applied
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25/08/2005
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Last edited
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17/09/2009
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Date ISRCTN assigned
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28/10/2005
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