Effect Levosimendan Administration on Postoperative NT-proBNP in Cardiac Risk Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

230 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-10

Study Completion Date

2024-12-18

Brief Summary

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This is a prospective randomised trial investigating the effect of a preemptive administration of levosimendan on postoperative cardiac NT-proBNP concentrations.

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Detailed Description

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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 natriuretic peptide (NT-proBNP) increases in over two third of patients undergoing surgery and is a strong predictor for perioperative myocardial complications. Levosimendan is a positive inotropic Ca2+ sensitizer and significantly reduces postoperative BNP concentration in cardiac surgery. The evidence in the non-cardiac surgery setting, however, is weak. Therefore, we will test our primary hypothesis that the perioperative administration of levosimendan significantly will reduce postoperative NT-proBNP concentrations in patients undergoing moderate- to high-risk non-cardiac surgery. We will also test the secondary hypotheses that levosimendan will reduce postoperative maximum troponin T (maxTnT) concentration, the incidence of myocardial injury after noncardiac surgery (MINS), myocardial infarction and death within 30 days and one year after surgery.

Conditions

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Cardiovascular Risk Factor

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Levosimendan

Patients receive a continuous infusion of 12.5mg solved in 50mL Levosimendan for up to 24 hours. Infusion will be started with surgical skin incision.

Group Type ACTIVE_COMPARATOR

Levosimendan

Intervention Type DRUG

Levosimendan 2.5 mg/ml injection contains levosimendan 2.5 mg, povidone 10.0 mg, citric acid, anhydrous 2.0 mg and ethanol, anhydrous to 1.0 mL. Levosimendan injection is a clear, yellow to orange solution. Immediately after skin incision patients allocated to the verum group will receive a dose of 12.5 mg in 500 mL of levosimendan.

Placebo

Patients receive a continuous infusion containing a placebo solved in 50mL for up to 24 hours. Infusion will be started with surgical skin incision.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo 2.5 mg/ml injection contains riboflavine sodium phosphate 0.4 mg, dehydrated alcohol 100 mg and water for injection to 1 mL.

Immediately after skin incision patients allocated to the placebo group will receive 500 mL of 5% Glucose.

Interventions

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Levosimendan

Levosimendan 2.5 mg/ml injection contains levosimendan 2.5 mg, povidone 10.0 mg, citric acid, anhydrous 2.0 mg and ethanol, anhydrous to 1.0 mL. Levosimendan injection is a clear, yellow to orange solution. Immediately after skin incision patients allocated to the verum group will receive a dose of 12.5 mg in 500 mL of levosimendan.

Intervention Type DRUG

Placebo

Placebo 2.5 mg/ml injection contains riboflavine sodium phosphate 0.4 mg, dehydrated alcohol 100 mg and water for injection to 1 mL.

Immediately after skin incision patients allocated to the placebo group will receive 500 mL of 5% Glucose.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

All patients need to meet all of the following criteria for inclusion (1-4):

1. Undergoing major surgery planned for more than 2 hours
2. ≥ 65 years of age and ≤ 85 years of age
3. Provide written informed consent AND
4. 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 Criteria

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

Minimum Eligible Age

65 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No