A double-blind randomised controlled clinical trial of levosimendan vs dopexamine in septic shock

ISRCTN	ISRCTN46862968
DOI	https://doi.org/10.1186/ISRCTN46862968
Protocol serial number	N0025154509
Sponsor	Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Funders	Aintree Hospitals NHS Trust (UK), NHS R&D Support Funding (UK)

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

Dr Gerard Dempsey
Scientific

Critical Care Unit
Anaesthesia Department
University Hospital Aintree
Longmoor Lane
Liverpool
L9 7AL
United Kingdom

Primary study design	Interventional
Study design	Randomised controlled trial (pilot study) with randomisation into two groups, double blinded
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	Levosimendan, dopexamine
Primary outcome measure(s)	Not provided at time of registration
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	20/09/2007

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target sample size at registration	20
Key inclusion criteria	Not provided at time of registration
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/12/2004
Date of final enrolment	20/09/2007

Critical Care Unit

Liverpool
L9 7AL
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan