Condition category
Circulatory System
Date applied
25/08/2005
Date assigned
28/10/2005
Last edited
03/03/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

academic

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

Results - basic reporting

Publication summary

Publication citations

Additional files

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.