Heart Failure, Hip Fracture
Conditions
Brief summary
The purpose of this study is to investigate the safety and efficacy of Levosimendan given preoperative to patients with heart failure undergoing noncardiac surgery.
Interventions
DRUGLevosimendan
At least 2 hours before surgery: Infusion of Levosimendan (0,1 microgram/kg/min.). 24 hours of infusion without a bolus.
DRUGPlacebo
ml/kg/hours - same infusion rate as active comparator
Sponsors
Orion Corporation, Orion Pharma
Sykehuset i Vestfold HF
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Acute surgery. Hip Fracture * Patient with cardiac failure (EF \< 35%) or known coronary disease * At least 2 of 11 comorbidities * Patient has to use at least one heart failure medication * Symptoms of heart failure * NT-proBNP \> 2000pg/ml
Exclusion criteria
* \< 18 years old * Participants in other pharmacological study * Abuse of medicaments or alcohol * Pregnant or breastfeeding women * AMI at admission * HOCM * Serious aortic stenosis (\< 1 cm2) * Sustained ventricular tachycardia * Earlier episodes of torsades de pointes * Sustained heartbeat \> 120/minute * Systolic BP \< 90 mmHg * Surgery planned not before 2 hours of study medication can be infused preoperative * Cardiac surgery * Dementia * S-K \< 3 mmol/l * Allergy levosimendan * Serious liver failure (Known Class C Child-Pugh score) * Serious kidney failure (GFR \< 30 ml/min.) * Prolonged QTc-interval (male QTc \> 0,43 s, female QTc \> 0,45 s)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Heartfailure - Highest NT-proBNP-value the first 7 days after surgery | NT-proBNP 6 hours postoperative, 24 hours postoperative, 48 h postoperative, 72 h postoperative, 96 h postoperative, 120 h postoperative, 144 h postoperative and 168 h postoperative |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Days of hospitalization | Hospital stay - number of days patients are hospitalized | — |
| Use of inotropes (dopamine, Norepinephrine)during postoperative unit stay. Mg/microgram | After 16-18 hours, after 48 hours and every 24 hours if still in the PO-Unit | — |
| Mortality | 30 days | Visits or patients record |
| Ischemia | 7 days postoperative | Continous ECG first 24 hours an ECG every second day |
| Myocardial necrosis | 7 days postoperative | Troponin taken every day postoperative |
Countries
Norway, Sweden
Outcome results
None listed