Pertti K Suominen1, Juho Keski-Nisula2, Tiina Ojala3, Paula Rautiainen2, Timo Jahnukainen3, Johanna Hästbacka2, Pertti J Neuvonen4, Olli Pitkänen3, Jussi Niemelä3, Anu Kaskinen3, Jukka Salminen5, Risto Lapatto3. 1. Department of Anesthesia and Intensive Care, Children's Hospital, Helsinki University Hospital and University of Helsinki, Helsinki, Finland. Electronic address: pertti.suominen@hus.fi. 2. Department of Anesthesia and Intensive Care, Children's Hospital, Helsinki University Hospital and University of Helsinki, Helsinki, Finland. 3. Department of Pediatrics, Children's Hospital, Helsinki University Hospital and University of Helsinki, Helsinki, Finland. 4. Department of Clinical Pharmacology, University of Helsinki and HUSLAB, Helsinki University Hospital, Helsinki, Finland. 5. Department of Pediatric Surgery, Children's Hospital, Helsinki University Hospital and University of Helsinki, Helsinki, Finland.
Abstract
BACKGROUND: Corticosteroids can improve the hemodynamic status of neonates with postoperative low cardiac output syndrome after cardiac operations. This study compared a prophylactically administered stress-dose corticosteroid (SDC) regimen against placebo on inflammation, adrenocortical function, and hemodynamic outcome. METHODS:Forty neonates undergoing elective open heart operations were randomized into two groups. The SDC group received perioperatively 2 mg/kg methylprednisolone, and 6 hours after the operation, a hydrocortisone infusion (0.2 mg/kg/h) was started with tapering doses for 5 days. Placebo was administered in a similar fashion. An adrenocorticotropic hormone stimulation test was performed after the therapy. The primary endpoint of the study was plasma concentration of interleukin (IL-6). Secondary clinical outcomes included plasma cortisol, IL-10, C-reactive protein, echocardiographic systemic ventricle contractility evaluated by the Velocity Vector Imaging program, the inotropic score, and time of delayed sternal closure. RESULTS: The IL-6 values of the SDC group were significantly lower postoperatively than in the placebo group. Significantly lower inotropic scores (p < 0.05), earlier sternal closure (p = 0.03), and less deterioration in the systemic ventricle mean delta strain values between the preoperative and the first postoperative assessment (p = 0.01) were detected for the SDC group. The SDC therapy did not suppress the hypothalamic-pituitary-adrenal axis more than placebo. The mean plasma cortisol level did not decline in the placebo group after the operation. CONCLUSIONS: The SDC regimen for 5 days postoperatively in neonates was safe and did not cause suppression of the hypothalamic-pituitary-adrenal axis. Furthermore, the open heart operation per se did not lead to adrenal insufficiency in neonates.
RCT Entities:
BACKGROUND: Corticosteroids can improve the hemodynamic status of neonates with postoperative low cardiac output syndrome after cardiac operations. This study compared a prophylactically administered stress-dose corticosteroid (SDC) regimen against placebo on inflammation, adrenocortical function, and hemodynamic outcome. METHODS: Forty neonates undergoing elective open heart operations were randomized into two groups. The SDC group received perioperatively 2 mg/kg methylprednisolone, and 6 hours after the operation, a hydrocortisone infusion (0.2 mg/kg/h) was started with tapering doses for 5 days. Placebo was administered in a similar fashion. An adrenocorticotropic hormone stimulation test was performed after the therapy. The primary endpoint of the study was plasma concentration of interleukin (IL-6). Secondary clinical outcomes included plasma cortisol, IL-10, C-reactive protein, echocardiographic systemic ventricle contractility evaluated by the Velocity Vector Imaging program, the inotropic score, and time of delayed sternal closure. RESULTS: The IL-6 values of the SDC group were significantly lower postoperatively than in the placebo group. Significantly lower inotropic scores (p < 0.05), earlier sternal closure (p = 0.03), and less deterioration in the systemic ventricle mean delta strain values between the preoperative and the first postoperative assessment (p = 0.01) were detected for the SDC group. The SDC therapy did not suppress the hypothalamic-pituitary-adrenal axis more than placebo. The mean plasma cortisol level did not decline in the placebo group after the operation. CONCLUSIONS: The SDC regimen for 5 days postoperatively in neonates was safe and did not cause suppression of the hypothalamic-pituitary-adrenal axis. Furthermore, the open heart operation per se did not lead to adrenal insufficiency in neonates.
Authors: Timo Jahnukainen; Paula Rautiainen; Juuso Tainio; Tommi Pätilä; Jukka T Salminen; Juho Keski-Nisula Journal: Ann Card Anaesth Date: 2021 Oct-Dec
Authors: Ben Gibbison; José Carlos Villalobos Lizardi; Karla Isis Avilés Martínez; Daniel P Fudulu; Miguel Angel Medina Andrade; Giordano Pérez-Gaxiola; Alvin Wl Schadenberg; Serban C Stoica; Stafford L Lightman; Gianni D Angelini; Barnaby C Reeves Journal: Cochrane Database Syst Rev Date: 2020-10-12