An assessment of the effects of altering blood pressure on cerebral and systemic haemodynamics in patients with acute ischaemic stroke

ISRCTN	ISRCTN19958964
DOI	https://doi.org/10.1186/ISRCTN19958964
Secondary identifying numbers	N/A

Submission date: 25/08/2005
Registration date: 28/10/2005
Last edited: 03/03/2016

Recruitment status: Stopped
Overall study status: Stopped
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Philip Bath
Scientific

Division of Stroke Medicine
Clinical Sciences Building
City Hospital Campus
Hucknall Road
Nottingham
NG5 1PB
United Kingdom

Phone	+44 (0)115 840 4792
Email	philip.bath@nottingham.ac.uk

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Scientific title	An assessment of the effects of altering blood pressure on cerebral and systemic haemodynamics in patients with acute ischaemic stroke
Study objectives	To assess the effects of altering blood pressure on cerebral and systemic haemodynamics in patients with acute ischaemic stroke.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	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 study start date	01/01/2000
Completion date	01/01/2007
Reason abandoned (if study stopped)	Participant recruitment issue

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	24
Key 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
Key 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
Date of first enrolment	01/01/2000
Date of final enrolment	01/01/2007

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Division of Stroke Medicine

Nottingham
NG5 1PB
United Kingdom

Sponsor information

University of Nottingham
University/education

Clinical Sciences Building
City Hospital Campus
Hucknall Road
Nottingham
NG5 1PB
England
United Kingdom

Phone	+44 (0)115 840 4791
Email	phillip.bath@nottingham.ac.uk
"ROR"	https://ror.org/01ee9ar58

Funders

Funder type

University/education

University of Nottingham
Private sector organisation / Universities (academic only)

Location: United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Editorial Notes

03/03/2016: This study was abandoned on 07/01/2005 due to low recruitment rate.
01/03/2016: No publications found, verifying study status with principal investigator.