Patients with serious cardiac failure scheduled for non-cardiac surgery MedDRA version: 14.1 Level: LLT Classification code 10006387 Term: Broken hip System Organ Class: 10022117 - Injury, poisoning and procedural complications MedDRA version: 14.1 Level: PT Classification code 10007559 Term: Cardiac failure congestive System Organ Class: 10007541 - Cardiac disorders MedDRA version: 14.1 Level: PT Classification code 10007554 Term: Cardiac failure System Organ Class: 10007541 - Cardiac disord
Conditions
Interventions
Trade Name: Simdax
Product Name: Simdax
Pharmaceutical Form:
INN or Proposed INN: LEVOSIMENDAN
CAS Number: 141505-33-1
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Conc
Sponsors
Sykehuset i Vestfold HF
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion Criteria 1. Patients scheduled for acute or elective surgery (there must be time for at least 2 hours of infusion of the study medication prior to the start of surgery) 2. The planned duration of the surgical procedure must be at least one (1) hour 3. The acute surgery has to be either implantation of hemi- or total hip prosthesis 4. The elective surgical procedure must be Abdominal aortic surgery Pheripheral surgery on arteries Carotide surgery (trombenartectomy) Intraabdominal and intrathoracal surgery Ortopedic surgery on spine. Implantation of hemi- or total prothesis - knee or hip. Radical prostatectomy, transurethral excluded. Cystectomy Hysterectomy Nephrectomy 5. A) Preoperative echovariable test performed within last 12 months prior to inclusion: EF = 35%. If an Acute myocardial infarction (AMI) last 12 months,the echocardiographic test must have been done > 1 months after an AMI or B) Known cardiac failure. 6. NT-proBNP > 2000 pg/ml or 4000 pg/ml if renal failure (GFR=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Exclusion Criteria 1. Patients under the age of 18 2. Patients participating in another pharmaceutical study 3. Known abuse of opioids, benzodiazepines, anti-epileptic drugs, a2-agonists or alcohol 4. Pregnant or breastfeeding women. Women of childbearing age must have a negative pregnancy test. 5. Acute myocardial infarction last month before admission 6. Cardiac failure as a result of hypertrophic cardiomyopathy 7. Verified severe aortic stenosis (aortic valve area 120/minute 11. Systolic BP 3 mmol/l is not an exclusion) 13. Inability to give consent due to, e.g. dementia 14. Hypersensitivity to levosimendan or its excipients 15. Severe liver failure (known liver cirrhosis - Child-Pugh grade C) 16. Severe renal failure (GFR 200 mmol/l). Treated prerenal failure with GFR >30 ml/minute or creatinine 0.43 s, women QTc > 0.45 s) 18. Patient not expected to fullfill the study period according to anesthesiologist estimation 19. Use of sulfonurea medication last 24 hours before inclusion 20. Planned use of ketamine.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To find differences between the 2 groups on cardiac outcomes. Does levosimendan given prophylactic perioperative, protect or enhance cardiac function compared to placebo? The primary endpoint is maximum change from baseline to postoperative NT-proBNP value. In addition, mean NT-proBNP response will be estimated over the time for each of the treament groups. ;Secondary Objective: We will also compare infusion with levosimendan vs. placebo for these parameters: Troponin T, hemodynamic parametres (CI, CO, SV, SVI) cardiovascular complications, use of inotrope/vasopressors, hospital- and ICU-stay, mortality after 30 days.;Primary end point(s): NT-proBNP will be measured preoperatively, thereafter 6, 24, 48, 72, 96, 120, 144, 168 hours after last stitch postoperatively (or only until the patient is discharged from hospital), up to a maximum of 168 hours postoperatively. The primary endpoint is maximum change from baseline to postoperative NT-proBNP value. In addition, mean NT-proBNP response will be estimated over the time for each of the treament groups. ;Timepoint(s) of evaluation of this end point: 6, 24, 48, 72, 96, 120, 144, 168 hours after last stitch postoperatively. Blood samples only if attendance at the hospital | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Troponin T - myocardial necrosis Ischemia (ECG) hemodynamic parametres (CI, CO, SV, SVI) cardiovascular complications use of inotrope/vasopressors hospital- and ICU-stay mortality after 30 days;Timepoint(s) of evaluation of this end point: Troponin T - Daily during admission Ischemia (ECG) - continuous first 24 hours, after that 3rd, 5th and 7th day postoperatively hemodynamic parametres (CI, CO, SV, SVI) first 24 hours postoperatively cardiovascular complications - during admission + 30 day follow-up use of inotrope/vasopressors first 24 hours postoperatively hospital- and ICU-stay during admission mortality after 30 days - 30 days follow-up | — |
Countries
Sweden
Outcome results
None listed