Mechanisms of cardio and nephroprotection in patients who are going on cardiac surgery with right ventricular dysfunction, with preoperative treatment of levosimendan compared with placebo. (PRELEVD-Pilot Study)

Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud (FIMABIS)0 个研究点目标入组 20 人开始时间: 2019年1月22日最近更新: 2019年6月30日

试验速览

暂无简介。

•. Patients = 18 years
•Patients with preoperative right ventricular dysfunction (TAPSE <17 mm, RV dilatation> 39 mm, tricuspid annulus dilatation> 40 mm), diagnosed by preoperative transthoracic echocardiography.
•Give informed consent.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 20

•. History of adverse event related to levosimendan.
•Patients in a situation of hemodynamic instability.
•Preoperative renal dysfunction, estimated through the preoperative GFR rate (creatinine clearance <50ml / min).
•Hypersensitivity to levosimendan or to any of the excipients.
•Significant mechanical obstructions affecting ventricular filling or emptying or both.
•History of Torsade de Pointes.
•Cardiogenic shock situation (lactate> 4 mmol / L)
•TAS before the infusion <100 mmHg (recommendation of the Spanish Society of Cardiology)
•Some serious situation at the discretion of the researcher.

发起方

Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud (FIMABIS)