Status:
COMPLETED
Effect Levosimendan Administration on Postoperative NT-proBNP in Cardiac Risk Patients
Lead Sponsor:
Medical University of Vienna
Conditions:
Cardiovascular Risk Factor
Eligibility:
All Genders
65-85 years
Phase:
PHASE3
Brief Summary
This is a prospective randomised trial investigating the effect of a preemptive administration of levosimendan on postoperative cardiac NT-proBNP concentrations.
Detailed Description
Major cardiovascular complications occur in about 3 % of all patients undergoing noncardiac surgery and are even higher in patients with increased preoperative risk factors. N-terminal pro brain natri...
Eligibility Criteria
Inclusion
- All patients need to meet all of the following criteria for inclusion (1-4):
- Undergoing major surgery planned for more than 2 hours
- ≥ 65 years of age and ≤ 85 years of age
- Provide written informed consent AND
- Fulfill ≥ 2 of the following criteria (A-E)
- A) NT-proBNP ≥ 200 ng/L
- B) History of coronary artery disease defined as 1 of the following 7 criteria (I to VII):
- I) History of angina
- II) History of myocardial infarction or acute coronary syndrome
- III) History of a segmental cardiac wall motion abnormality on echocardiography/radionuclide imaging
- IV) History of positive myocardial stress test (echocardiographic or radionuclide)
- V) History of a coronary artery stenosis \> 50%
- VI) ECG with pathological Q waves in any two contiguous leads
- VII) History of previous artery revascularizations
- C) History of permanent/paroxysmal atrial fibrillation diagnosed by physician/specialist
- D) History of peripheral arterial disease as defined by a physician/specialist diagnosis of a current, or prior history of any 1 of the following 5criteria (I-V)
- I) Intermittent claudication
- II) Stenosis ≥ 70 % detected by angiography or doppler
- III) Stenosis ≤ 70% detected by angiography or doppler AND requiring medical treatment e.g. ASA or other platelet inhibitor
- IV) History of stroke or TIA - diagnosed by physician or CT/MRI
- V) Diagnosed cerebral arteriovascular disease (cAVK) diagnosed by a physician/specialist
- E) Any 3 of 10 of the following risk criteria (i - x).
- i. History of congestive heart failure defined as a physician diagnosis of a current or prior episode of congestive heart failure OR prior radiographic evidence of vascular redistribution, interstitial pulmonary edema, or frank alveolar pulmonary edema;
- ii. History of a transient ischemic attack;
- iii. Diabetes and currently taking an oral hypoglycemic agent or insulin;
- iv. History of hypertension;
- v. Hyperlipidemia and currently taking a lipid lowering agent;
- vi. Documented chronic kidney disease diagnosed by physician/specialist and creatinine clearance \> 30 ml/min
- vii. History of smoking within 2 years of surgery
- viii. Diastolic dysfunction (≥ grade 1) documented by echocardiography
- ix. Age ≥ 70 years
- x. Preoperative Troponin T (5th generation) ≥ 25ng/dL
Exclusion
- A) Previous adverse response and/or allergy to levosimendan B) ICU Patients undergoing surgery C) Preoperative Sepsis/SIRS needing ICU treatment D) Preoperative hemodynamically instable patients, who requirevasopressor or inotropic support E) Renal or liver transplantation F) History of severe heart failure (e.g. LVEF \< 30%) G) Patients undergoing surgery for pheochromocytoma H) Liver cirrhosis I) Pulmonary hypertension (mPAP \> 25 mmHg) J) Severe Renal Failure defines as creatinine clearance ≤ 30ml/min
Key Trial Info
Start Date :
October 10 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 18 2024
Estimated Enrollment :
230 Patients enrolled
Trial Details
Trial ID
NCT04329624
Start Date
October 10 2020
End Date
December 18 2024
Last Update
May 8 2025
Active Locations (1)
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1
Medical University of Vienna
Vienna, Vienna, Austria, 1100