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17 May 2008
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| [ Print-friendly version ] |
| LEVOsimendan before Heart-Lung-Machine in coronary artery bypass graft operations |
| ISRCTN | ISRCTN85175364 |
| ClinicalTrials.gov identifier | |
| Public title | LEVOsimendan before Heart-Lung-Machine in coronary artery bypass graft operations |
| Scientific title | |
| Acronym | LEVOHLM |
| Serial number at source | N/A |
| 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) |
| Ethics approval | Ethics Committee of Berlin (Landesamt für Gesundheit und Soziales Geschäftsstelle der Ethik-Kommission des Landes Berlin), approved on 28th December 2007. |
| Study design | Prospective, randomised, placebo-controlled, double-blinded, two-arm, single-center trial. |
| Countries of recruitment | Germany |
| Disease/condition/study domain | Coronary artery disease/ coronary artery bypass graft operations |
| Participants - inclusion criteria |
1. Offered patient information and obtained informed consent
2. Age 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 ischemic cardiomyopathy with or without heart valve repair 6. Left ventricular ejection fraction under 30% 7. Compensated renal insufficiency (creatinine >1,14 mg/dl) |
| Participants - exclusion criteria |
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 >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 HIV 12. Active hepatitis B or C 13. Unclear history of alcohol related disorder |
| Anticipated start date | 05/02/2008 |
| Anticipated end date | 01/02/2010 |
| Status of trial | Ongoing |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Target number of participants | 100 |
| Interventions |
Levosimendan (Simdax [R]) 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 (R) (multivitamin solution for colouring the medication) |
| Primary outcome measure(s) | 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 measure(s) |
1. Hemodynamic 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 hemodialysis 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 |
| Sources of funding | Charité - University Medicine Berlin (Charité - Universitätsmedizin Berlin) (Germany) |
| Trial website | |
| Publications | |
| Contact name | Prof Claudia Spies |
| Address | Charitéplatz 1 |
| City/town | Berlin |
| Zip/Postcode | 10117 |
| Country | Germany |
| claudia.spies@charite.de | |
| Sponsor | Charité - University Medicine Berlin (Charité - Universitätsmedizin Berlin) (Germany) |
| Address | Charitéplatz 1 |
| City/town | Berlin |
| Zip/Postcode | 10117 |
| Country | Germany |
| anaesth@charite.de | |
| Date applied | 04/02/2008 |
| Last edited | 11/04/2008 |
| Date ISRCTN assigned | 11/04/2008 |
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