Double-blind randomized clinical trial to evaluate the efficacy and safety of levosimendan as preischemic myocardial conditioner in pediatric cardiac surgery

FUNDACION PARA LA INVESTIGACIÓN BIOSANITARIA DE ANDALUCIA ORIENTAL_ FPA0 个研究点开始时间: 2013年2月4日最近更新: 2013年7月15日

适应症

试验速览

暂无简介。

•(existing mandatory general criteria: the existence of an informed consent of father / mother / guardian): patients at high risk of developing postoperative acute heart failure, for which require at least two of the following factors: age less than 6 months or less to 7kg weight at the time of surgery, patients in heart failure situation before surgery, bypass time estimated by the complexity of the surgery than 100 minutes, preoperative patients with pulmonary hypertension or increased risk of hypertension postoperative lung.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 36
•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) no
•F.1.3.1 Number of subjects for this age range

•Negative states of parents or guardians to participate in the study or refusal to sign the informed consent of the father / mother / guardian.
•-Not meet at least two of the factors include or found before surgery in low cardiac output state set.
•- Allergy or hypersensitivity to other components Levosimendan Simdax ®.
•-Patients who can not prescribe medication be contraindicated as study sheet: mechanical obstructions affecting ventricular filling or discharge or both, severe renal impairment (CrCl <30 ml / min), severe hepatic impairment, hypotension refractory malignant arrhythmias (Torsades de Pointes).
•-History of autoimmune disease.

发起方

FUNDACION PARA LA INVESTIGACIÓN BIOSANITARIA DE ANDALUCIA ORIENTAL_ FPA