Preoperative Sildenafil administration in children undergoing cardiac surgery: a randomized controlled preconditioning study

Autor: Ward Y. Vanagt, Tammo Delhaas, Kiran Viralam, Shreesha Maiya, Stefan Frerich, Egmond S Evers, Bart Spronck, Frits W. Prinzen, Chinnaswamy Reddy, Shekhar Rao, Suresh Pujar, Varsha Walavalkar, Colin John
Přispěvatelé: Biomedische Technologie, Kindergeneeskunde, MUMC+: MA Medische Staf Kindergeneeskunde (9), Promovendi CD, Fysiologie, RS: CARIM - R2.08 - Electro mechanics, RS: CARIM - R2.09 - Cardiovascular system dynamics
Rok vydání: 2015
Předmět:
Zdroj: European Journal of Cardio-Thoracic Surgery, 49(5), 1403-1410. Oxford University Press
ISSN: 1873-734X
1010-7940
DOI: 10.1093/ejcts/ezv353
Popis: OBJECTIVES Sildenafil has strong cardiac preconditioning properties in animal studies and has a safe side-effect profile in children. Therefore, we evaluated the application of Sildenafil preconditioning to reduce myocardial ischaemia/reperfusion injury in children undergoing surgical ventricular septal defect (VSD) closure. METHODS This is a randomized, double-blind study. Children (1-17 years) undergoing VSD closure were randomized into three groups: placebo (Control group), preconditioning with 0.06 mg/kg (Sild-L group) and 0.6 mg/kg Sildenafil (Sild-H group). PRIMARY ENDPOINT troponin release. CK-MB, Troponin I, inflammatory response (IL-6 and TNF-α), bypass and ventilation weaning times, inotropy score and echocardiographic function were assessed. Data expressed as median (range), and a value of P < 0.05 was considered significant. RESULTS Thirty-nine patients were studied (13/group). Aortic cross-clamp time was similar [27 (18-85) and 27 (12-39) min] in the Control and Sild-L groups, respectively, but significantly longer [39 (20-96) min] in the Sild-H group when compared with the Control group. Area under the curve of CK-MB release was 1105 (620-1855) h ng/ml in the Control group, 1672 (564-2767) h ng/ml in the Sild-L group and was significantly higher in the Sild-H group [1695 (1252-3377) h ng/ml] when compared with the Control group. There were no significant differences in inflammatory response markers, cardiopulmonary bypass and ventilation weaning times, inotropy scores and echocardiographic function between the groups. CONCLUSIONS In this small study, Sildenafil failed to reduce myocardial injury in children undergoing cardiac surgery, nor does it alter cardiac function, inotropic needs or postoperative course. A subclinical increase in cardiac enzyme release after Sildenafil preconditioning cannot be excluded. CLINICAL TRIALS REGISTRY CTRI/2014/03/004468.
Databáze: OpenAIRE