Not provided
Not provided
Not provided
Not provided
Not finding patients for including
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Orion Corporation, Orion Pharma | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to investigate the safety and efficacy of Levosimendan given preoperative to patients with heart failure undergoing noncardiac surgery.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Levosimendan | Active Comparator |
| |
| Povidon, waterfree etanol, glucosis 5% | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Levosimendan | Drug | At least 2 hours before surgery: Infusion of Levosimendan (0,1 microgram/kg/min.). 24 hours of infusion without a bolus. |
|
| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Espen Lindholm, MD | Vestfold Hospital trust, Norway | Study Director |
| Knut A Kirkebøen, PhD | Oslo University Hospital - Ullevål, Norway | Principal Investigator |
| Mathias Kotyra, Md | Mölndal hospital, Sweden | Principal Investigator |
| Anders Nydahl, Phd | University Hospital Örebro, Sweden | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oslo University Hospital - Ullevål | Oslo | Norway | ||||
| Vestfold Hospital Trust |
Not provided
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D006620 | Hip Fractures |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D005264 | Femoral Fractures |
| D050723 | Fractures, Bone |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077464 | Simendan |
| ID | Term |
|---|---|
| D006835 | Hydrazones |
| D006834 | Hydrazines |
| D009930 | Organic Chemicals |
| D011724 | Pyridazines |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Placebo | Drug | ml/kg/hours - same infusion rate as active comparator |
|
| Mortality | Visits or patients record | 30 days |
| Ischemia | Continous ECG first 24 hours an ECG every second day | 7 days postoperative |
| Myocardial necrosis | Troponin taken every day postoperative | 7 days postoperative |
| Tønsberg |
| 3103 |
| Norway |
| Mölndal Hospital | Gothenburg | Sweden |
| Universitety Hospital Örebro | Hudiksvall | Sweden |
| D014947 |
| Wounds and Injuries |
| D025981 | Hip Injuries |
| D007869 | Leg Injuries |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |