Randomised controlled trial of Levosimendan vs Enoximone in Cardiogenic Shock
| ISRCTN | ISRCTN87369174 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN87369174 |
| Protocol serial number | N0025128433 |
| Sponsor | Department of Health |
| Funder | Aintree Hospitals NHS Trust (UK) |
- Submission date
- 30/09/2004
- Registration date
- 30/09/2004
- Last edited
- 28/02/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
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
| Phone | +44 (0)151 529 5152 |
|---|
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Prospective double blind randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 / device / biological / vaccine name(s) | Levosimendan, Enoximone |
| Primary outcome measure(s) |
Not provided at time of registration |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 25/09/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Not Specified |
| Target sample size at registration | 12 |
| Key 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. |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/05/2004 |
| Date of final enrolment | 25/09/2007 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Critical Care Unit
Liverpool
L9 7AL
United Kingdom
L9 7AL
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
