The drug Levosimendan / Simdax (R) will be investigated in patients undergoing coronary artery bypass graft operations. The study population will be patients with impaired myocardial function as stated with an ejection fraction equal or lower than 30 %. The study medication will be applied after establishing completed hemodynamic monitoring and maintained throughout the operation for twelve hours.
Conditions
Interventions
Trade Name: Simdax (R)
Product Name: Simdax
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Levosimendan
Concentration unit: mg/ml milligram(s)/millilitre
Concentration
Sponsors
Charité - Universitätsmedizin Berlin
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Written informed consent by the patient to participate in the study (according to AMG §40 (1) 3b) • Age older than 18 years • Negative pregnancy testing or being postmenopausal for more than two years • No participation in another clinical AMG trial • Patients undergoing elective CABG-surgery with/without valve correction procedures • Left ventricular ejection fraction equal or smaller than 30 % Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • A patient is commited to an institution because of an official or medical order (according to AMG §40 (1) 4) • No informed written consent by the patient • Participation in another clinical study • ASA > III • Severe oesophageal or upper airway disease • Recent oesophageal or upper airway surgery • Liver disease (Child B or C cirrhosis, akute disease, MILD Score > 17) • Age < 18 ys. • Unclear history of alcohol use disorder • Neurological or psychiatric diseases • Treatment with oral antidiabetics • Presence of of an infection with HIV and symptoms of AIDS • Clinical or anamnestic signs for the presence of an active Hepatitis B / C infection
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The aim of the study is to reduce the MODS meassured by the SOFA score by application of Levosimendan in patients undergoing coronary artery bypass graft-operations. The study population will be patients with impaired myocardial function preoperatively. ;Secondary Objective: The secondary objective of the trial is to elucidate the effects of Levosimedan in cardiac surgery on the incidence of renal hemodialysis and infections, the need for catecholamines perioperatively and the length of stay and quality of life.;Primary end point(s): Daily SOFA scores | — |
Countries
Germany
Outcome results
None listed