PERIOPERATIVE LEVOSIMENDAN INFUSION IN PATIENTS WITH HEART FAILURE UNDERGOING NON-CARDIAC SURGERY: A PROSPECTIVE, RANDOMISED, PLACEBO-CONTROLLED, DOUBLE-BLIND, MULTICENTER STUDY - SIMPLE

Sykehuset i Vestfold HF0 个研究点目标入组 70 人开始时间: 2010年11月25日最近更新: 2013年4月1日

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•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.
•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 AMIor
•B)Known cardiac failure.
•6.NT-proBNP > 2000 pg/ml or 4000 pg/ml if renal failure (GFR<50)
•7.The patient has to use at least one of these medicaments:
•a.ACE- inhibitors
•bAngiotensin receptor blockers
•c.Diuretics
•d.Digoxin/Digitoxin
•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
•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 < 1 cm2) or/and 50 mmHg (mean gradient)
•8.Persistent ventricular tachycardia
•9.History of torsades des pointes
•10.Persistent heart rate > 120/minute
•11.Systolic BP < 90 mmHg (non-invasive)
•12.S-potassium < 3 mmol/l (treated low s-pottasium to > 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 < 30 ml/minute or creatinine > 200 mmol/l). Treated prerenal failure with GFR >30 ml/minute or creatinine < 200 mmol/l is not an exclusion.
•17.Prolonged QTc interval (men QTc > 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.

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