LEVOsimendan before Heart-Lung-Machine in coronary artery bypass graft operations
| ISRCTN | ISRCTN85175364 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN85175364 |
| Secondary identifying numbers | N/A |
- Submission date
- 04/02/2008
- Registration date
- 11/04/2008
- Last edited
- 20/05/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English Summary
Not provided at time of registration
Contact information
Prof Claudia Spies
Scientific
Scientific
Charitéplatz 1
Berlin
10117
Germany
| claudia.spies@charite.de |
Study information
| Study design | Prospective randomised placebo-controlled double-blinded two-arm single-centre trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | |
| Study acronym | LEVOHLM |
| Study hypothesis | The goal of the study is to confirm the improvement of the Sepsis-related Organ Failure Assessment Scores (SOFA Score) with infusion of levosimendan compared with placebo in high risk patients undergoing coronary artery bypass graft-operations. The following hypothesis will be tested: H0 (null hypothesis): SOFA (levosimendan) equal to SOFA (placebo) HA (alternative hypothesis - two-sided): SOFA (levosimendan) not equal to SOFA (placebo) As of 08/05/2009 this record was updated to include amended participant criteria - for full details go to the relevant fields. At this time, the anticipated end date of this trial was also extended; the initial anticipated end date at the time of registration was 01/02/2010. |
| Ethics approval(s) | Ethics Committee of Berlin (Landesamt für Gesundheit und Soziales Geschäftsstelle der Ethik-Kommission des Landes Berlin), 28/12/2007. |
| Condition | Coronary artery disease/coronary artery bypass graft operations |
| Intervention | Levosimendan (Simdax®) group: continuous application of levosimendan at 0.1 µg/kg body weight/min (concentration of the applied solution: 250 µg/ml levosimendan, 5% glucose), cumulative dose: 72 µg/kg body weight Placebo group: 5% glucose and Soluvit® (multivitamin solution for colouring the medication) |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Levosimendan |
| Primary outcome measure | The Sepsis-related Organ Failure Assessment (SOFA) score to describe organ dysfunction/failure. The SOFA score will be measured daily during the patient's stay in the Intensive Care Unit (ICU). |
| Secondary outcome measures | 1. Haemodynamic values throughout surgery and during patient's stay in the ICU 2. Doses and duration of therapy with catecholamines 3. Echocardiographic parameter during surgery 4. Delta-creatinine clearance before and after surgery 5. Horowitz (oxygenation) index, measured every 12 hours during patient's stay in the ICU 6. Serum lactate values during surgery and patient's stay in the ICU 7. Survival after 30 days and after 6 months 8. Incidence and frequencies of haemodialysis during patient's stay in the ICU 9. Incidence and frequencies of hemodialysis after fulfilling ICU discharge criteria up to hospital discharge 10. Quality of life 6 months after surgery |
| Overall study start date | 05/02/2008 |
| Overall study end date | 31/03/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 100 |
| Participant inclusion criteria | Amended as of 08/05/2009: Point seven below is no longer an inclusion criteria and should be disregarded. Initial information at time of registration: 1. Offered patient information and obtained informed consent 2. Aged over 18 years old 3. Negative pregnancy test or anamnestically more than two years post-menopausal 4. No participation in another drug study according to the pharmaceutical law 5. Patients undergoing elective coronary artery bypass graft-surgery because of ischaemic cardiomyopathy with or without heart valve repair 6. Left ventricular ejection fraction less than or equal to 30% 7. Compensated renal insufficiency (creatinine greater than 1.14 mg/dl) |
| Participant exclusion criteria | Amended as of 08/05/2009: The following point has been amended: 10. Therapy with oral antidiabetics discontinued at least 36 hours before surgery Initial information at time of registration: 1. Age under 18 years old 2. Pregnancy or lactation 3. Lacking willingness to save and hand out pseudonymised data within the study 4. A patient is admittted to an institution because of an official or medical order (according to German Medicines Act [AMG] Sectoin 40 (1) 4) 5. Liver disease (Child B or C cirrhosis, acute disease, End-Stage Liver Disease [MELD] score greater than 17) 6. Recent oesophageal or upper airway surgery 7. Severe oesophageal disease 8. Severe disease of the upper airways 9. Neurological/psychiatric disease 10. Therapy with oral antidiabetics 11. Infection with human immunodeficiency virus (HIV) 12. Active hepatitis B or C 13. Unclear history of alcohol related disorder |
| Recruitment start date | 05/02/2008 |
| Recruitment end date | 31/03/2012 |
Locations
Countries of recruitment
- Germany
Study participating centre
Charitéplatz 1
Berlin
10117
Germany
10117
Germany
Sponsor information
Charité - University Medicine Berlin (Charité - Universitätsmedizin Berlin) (Germany)
University/education
University/education
Charitéplatz 1
Berlin
10117
Germany
| anaesth@charite.de | |
| Website | http://www.charite.de/ |
"ROR" |
https://ror.org/001w7jn25 |
Funders
Funder type
University/education
Charité - University Medicine Berlin (Charité - Universitätsmedizin Berlin) (Germany)
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/06/2014 | Yes | No |
