randomized clinical trial which included patients aged 1 month to 14 years who are to undergo cardiac surgery with high risk factors of postoperative acute heart failure to evaluate the efficacy and safety of levosimenda

Conditions: Children aged 1 month to 14 years in the health area of the province of Granada who will be undergoing heart surgery with a clinical high risk of developing acute heart failure after surgery, treated at the Unit Pediatric Intensive Care, University Hospital Virgen de las Nieves.
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]

Registration Number: EUCTR2012-005310-19-ES

Lead Sponsor: FUNDACION PARA LA INVESTIGACIÓN BIOSANITARIA DE ANDALUCIA ORIENTAL_ FPA

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

(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

Exclusion Criteria

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.