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.
Conditions
Interventions
Trade Name: SIMDAX
Product Name: levosimendan
Product Code: C01CX.
Pharmaceutical Form: Concentrate for solution for infusion
Pharmaceutical form of the placebo: Solution for infusion
Route of adminis
Sponsors
FUNDACION PARA LA INVESTIGACIÓN BIOSANITARIA DE ANDALUCIA ORIENTAL_ FPA
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: 1. To evaluate the effect of levosimendan on cardiac function. 2. Estimating the changes in the neurohormonal profile and promotes enzymatic levosimendan. 3. Evaluate serious adverse events that may appear in both groups. 4. Evaluate all-cause mortality. 5. Conduct an analysis of economic impact of using levosimendan.;Timepoint(s) of evaluation of this end point: at 0 hours, 12 and 24 hour after arraiving from surgery room;Primary end point(s): Hemodynamic: 12. Heart rate (HR) (bpm). 13. Mean arterial pressure (MAP) (mmHg) 14. Central venous pressure (CVP) (cmH20) (measured by placement of a central venous catheter in the right atrium) 15. Thermal gradient (measured in centigrade) 16. Capillary refill time (seconds) 17. Diuresis (ml / kg / hr) 18. Total dose of inotropic score VIS expressed as: (dose dopamine and dobutamine) + (milrinone × 10) + (adrenaline and noradrenaline x 1000) + (vasopresinax10) 19. Adrenaline, noradrenaline, dopamine, dobutamine and milrinone (mcg / kg / min) b) Analytical: 20. Cardiac Profile: atrial natriuretic peptide (BNP) (pg / dL), Troponin-I (TP-I) (ng / ml) and myoglobin (Mb) (ng / ml). 21. Metabolic profile: lactate: mmol / l, central venous oxygen saturation (Sav02) (%), oxygen transport (ml/min/m2).;Main Objective: To evaluate the efficacy and safety of levosimendan on myocardial preischemic conditioning in pediatric cardiac surgery child | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): days in PICU, days of mechanical ventilation, development C complications or serious adverse events (arrhythmias, hypotension requiring suspension, kidney or liver failure, death), survival at 30 days.;Timepoint(s) of evaluation of this end point: at 30 day after surgery | — |
Countries
Spain
Contacts
Public ContactHVN
Hospital Virgen de Las Nieves
Outcome results
None listed