Condition category
Circulatory System
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
28/02/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Gerard Dempsey

ORCID ID

Contact details

Critical Care Unit
Anaesthesia Department
University Hospital Aintree
Longmoor Lane
Liverpool
L9 7AL
United Kingdom
+44 (0)151 529 5152

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0025128433

Study information

Scientific title

Acronym

Study hypothesis

Does the use of Levosimendan (a calcium sensitiser) when compared with Enoximone improve measured cardiovascular parameters whilst reducing both the incidence of dysrhythmias and the use of additional inotropic support?

Ethics approval

Not provided at time of registration

Study design

Prospective double blind randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Cardiovascular: Cardiogenic shock

Intervention

Following assessment by the duty Consultant Intensivist invasive monitoring will be placed as part of the current standard clinical practice. All those satisfying both the inclusion and exclusion criteria will be randomised to receive either Levosimendan or Enoximone infusions, subject to obtaining their consent. The rate of loading dose and subsequent 24 hour infusion will be based on a standardised protocol. Cardiovascular parameters will be taken immediately before commencement of infusions to establish baseline readings. This data will be collected at 10 minutes, 1, 4, 6, 12 and 24 hours after starting the infusions. All members of staff will be blinded to the type of infusion given. Standard demographic and biochemical data will be collected from each patient. This will be collected on a standardised proforma by the investigators.

Intervention type

Drug

Phase

Not Specified

Drug names

Levosimendan, Enoximone

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/05/2004

Overall trial end date

25/09/2007

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients over 18 years of age.
2. All patients that are suspected of having cardiogenic shock during their admission to the Critical Care Unit will be identified.

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

12 adult patients - 6 in each arm

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/05/2004

Recruitment end date

25/09/2007

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Critical Care Unit
Liverpool
L9 7AL
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Funder name

Aintree Hospitals NHS Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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