Condition category
Signs and Symptoms
Date applied
29/09/2006
Date assigned
29/09/2006
Last edited
16/10/2014
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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0025154509

Study information

Scientific title

Acronym

Study hypothesis

To assess the role of levosimendan in preserving blood flow to the splanchnic circulation in septic shock as compared with dopexamine, with a secondary objective of whether there is improvement in cardiac performance.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial (pilot study) with randomisation into two groups, double blinded

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Signs and Symptoms: Sepsis

Intervention

Randomised controlled trial (pilot study) with randomisation into two groups, double blinded to minimise researcher bias, patients randomised to levosimendan or dopexamine, the randomisation code to be held by a non-participating intensive care pharmacist who will track any adverse effects. Those recruited will be administered an infusion of trial or control drug based on their body weight and following a set standardised protocol. Following 24 hours infusion of the study/control drug, all patients will be converted to an infusion of dopexamine at 1 mg if use of drug is still considered necessary.

Intervention type

Drug

Phase

Not Applicable

Drug names

Levosimendan, dopexamine

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/12/2004

Overall trial end date

20/09/2007

Reason abandoned

Eligibility

Participant inclusion criteria

Not provided at time of registration

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

20 patients, 10 in each group, following admission to Critical Care at Aintree Trust

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/12/2004

Recruitment end date

20/09/2007

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Critical Care Unit
Liverpool
L9 7AL
United Kingdom

Sponsor information

Organisation

Record Provided by the NHSTCT Register - 2006 Update - Department of Health

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

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

Funder name

NHS R&D Support Funding (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