Contact information
Type
Scientific
Primary contact
Prof Philip Bath
ORCID ID
Contact details
Division of Stroke Medicine
Clinical Sciences Building
City Hospital Campus
Hucknall Road
Nottingham
NG5 1PB
United Kingdom
+44 (0)115 840 4792
philip.bath@nottingham.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
An assessment of the effects of altering blood pressure on cerebral and systemic haemodynamics in patients with acute ischaemic stroke
Acronym
Study hypothesis
To assess the effects of altering blood pressure on cerebral and systemic haemodynamics in patients with acute ischaemic stroke.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Ischaemic Stroke
Intervention
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.
Intervention type
Drug
Phase
Not Specified
Drug names
Dobutamine
Primary outcome measure
1. The ability of dobutamine to reduce systolic, diastolic and mean arterial BP
2. Safety and tolerability of dobutamine in acute ischaemic stroke.
Secondary outcome measures
90 day modified Rankin, Barthel and mortality.
Overall trial start date
01/01/2000
Overall trial end date
01/01/2007
Reason abandoned (if study stopped)
Participant recruitment issue
Eligibility
Participant inclusion criteria
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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
24
Participant exclusion criteria
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
Recruitment start date
01/01/2000
Recruitment end date
01/01/2007
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Division of Stroke Medicine
Nottingham
NG5 1PB
United Kingdom
Sponsor information
Organisation
University of Nottingham
Sponsor details
Clinical Sciences Building
City Hospital Campus
Hucknall Road
Nottingham
NG5 1PB
United Kingdom
+44 (0)115 840 4791
phillip.bath@nottingham.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
University of Nottingham
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
Universities (academic only)
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list