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
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