The use of Landiolol in mitral valve sUrgery: a raNdomized, controlled, double-blind triAl. (LUNA)
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 1,500
- 试验地点
- 29
- 主要终点
- The primary outcome will be the reduction of the occurrence of postoperative low-cardiac output syndrome, defined following a recent JAMA publication (Cholley 2017) as the presence of at least one of the following:
研究概览
简要总结
To assess the effect of administering landiolol as cardioplegia adjuvant to reduce the occurrence of postoperative low-cardiac output syndrome.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Older than 18 years;
- •Undergoing elective mitral valve repair or replacement surgery with planned cardiopulmonary bypass via midline sternotomy or minithoracotomy;
- •Preoperative evidence of left ventricular end-systolic diameter >40 mm and/or left ventricular end-diastolic diameter >60 mm and/or left ventricular ejection fraction<60%;
- •Signed informed consent.
排除标准
- •Need for preoperative dialysis;
- •Patients with hypersensitivity to the active substance or to any of the excipients;
- •Patients with severe bradycardia (less than 50 beats per minute) sick sinus syndrome, severe atrioventricular nodal conductance disorders or 2nd -3rd degree atrioventricular block and without a pacemaker;
- •Patients with cardiogenic shock, severe hypotension (MAP<50 mmHg), decompensated heart failure or severe pulmonary hypertension (PAPs >70 mmHg);
- •Patients with non-treated phaeochromocytoma;
- •Patients with acute asthmatic attack;
- •Patients with severe, uncorrectable metabolic acidosis.
- •Participation in a clinical trial in which an investigational drug was administered within 30 days of screening or within the 5 half-lives of the study drug, whichever is longer.
- •Hepatic dysfunction (defined as Child-Pugh class C);
- •History of previous unusual response to beta-blockers;
- •Urgent or emergency surgery;
- •Patient already in need of mechanical circulatory support before surgery (except for IABP);
- •Pregnancy as documented by a pregnancy test performed in the last 72h before surgery
- •Refusal or inability to sign the informed consent.
- •Patients with preoperative evidence of hypernatremia (serum sodium concentration: > 160 mmol/L);
- •Patients with preoperative evidence of hyperchloremia (serum chloride concentration: >115 mmol/L);
结局指标
主要结局
The primary outcome will be the reduction of the occurrence of postoperative low-cardiac output syndrome, defined following a recent JAMA publication (Cholley 2017) as the presence of at least one of the following:
The primary outcome will be the reduction of the occurrence of postoperative low-cardiac output syndrome, defined following a recent JAMA publication (Cholley 2017) as the presence of at least one of the following:
need of prolonged catecholamine infusion (persisting beyond 48 hours after the initiation of the study drug);
need of prolonged catecholamine infusion (persisting beyond 48 hours after the initiation of the study drug);
need of circulatory mechanical assist devices in the postoperative period (if an intraaortic balloon pump was inserted preventively, the criteria will be met if patients are not weaned from the balloon within 96 hours);
need of circulatory mechanical assist devices in the postoperative period (if an intraaortic balloon pump was inserted preventively, the criteria will be met if patients are not weaned from the balloon within 96 hours);
need for renal replacement therapy at any time during the intensive care unit stay.
need for renal replacement therapy at any time during the intensive care unit stay.
次要结局
- Patients requiring prolonged (>48 h) catecholamine infusion;
- patients with increased postoperative cardiac biomarkers (Troponin I or T);
- patients with a reduction in left ventricular ejection fraction;
- number of patients readmitted to hospital for cardiac reasons;
- EQ-5D-5L questionnaire;
- death.
研究者
Fabrizio Monaco
Scientific
Ospedale San Raffaele S.r.l.