A double-blind randomised controlled clinical trial of levosimendan vs dopexamine in septic shock
| ISRCTN | ISRCTN46862968 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN46862968 |
| Secondary identifying numbers | N0025154509 |
- Submission date
- 29/09/2006
- Registration date
- 29/09/2006
- Last edited
- 16/10/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Signs and Symptoms
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
Contact information
Dr Gerard Dempsey
Scientific
Scientific
Critical Care Unit
Anaesthesia Department
University Hospital Aintree
Longmoor Lane
Liverpool
L9 7AL
United Kingdom
Study information
| Study design | Randomised controlled trial (pilot study) with randomisation into two groups, double blinded |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Levosimendan, dopexamine |
| Primary outcome measure | Not provided at time of registration |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/12/2004 |
| Completion date | 20/09/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | 20 patients, 10 in each group, following admission to Critical Care at Aintree Trust |
| 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 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Critical Care Unit
Liverpool
L9 7AL
United Kingdom
L9 7AL
United Kingdom
Sponsor information
Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Government
Government
The Department of Health, Richmond House, 79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| dhmail@doh.gsi.org.uk | |
| Website | http://www.dh.gov.uk/Home/fs/en |
Funders
Funder type
Government
Aintree Hospitals NHS Trust (UK)
No information available
NHS R&D Support Funding (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
