LEVOsimendan before Heart-Lung-Machine in coronary artery bypass graft operations

ISRCTN	ISRCTN85175364
DOI	https://doi.org/10.1186/ISRCTN85175364
Protocol serial number	N/A
Sponsor	Charité - University Medicine Berlin (Charité - Universitätsmedizin Berlin) (Germany)
Funder	Charité - University Medicine Berlin (Charité - Universitätsmedizin Berlin) (Germany)

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 of protocol

Not provided at time of registration

Contact information

Prof Claudia Spies
Scientific

Charitéplatz 1
Berlin
10117
Germany

Email	claudia.spies@charite.de

Study information

Primary study design	Interventional
Study design	Prospective randomised placebo-controlled double-blinded two-arm single-centre trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title
Study acronym	LEVOHLM
Study objectives	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.
Health condition(s) or problem(s) studied	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
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Levosimendan
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).
Key secondary outcome measure(s)	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
Completion date	31/03/2012

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	100
Key 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)
Key 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
Date of first enrolment	05/02/2008
Date of final enrolment	31/03/2012

Locations

Countries of recruitment

Germany

Study participating centre

Charitéplatz 1

Berlin
10117
Germany

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	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
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes