Randomized trial of the Terumo Capiox FX05 oxygenator with integral arterial filter versus Terumo Capiox Baby RX05 and Terumo Capiox AF02 arterial filter in infants undergoing cardiopulmonary bypass.

UNLABELLED: The purpose of this clinical trial was to evaluate the effect of the Terumo Capiox FX05 oxygenator with integrated arterial filter during cardiopulmonary bypass (CPB) compared with the Terumo Capiox RX05 Baby RX and arterial filter on inflammatory mediators and blood product utilization. Forty patients weighing less than 10 kg who underwent congenital heart surgery utilizing cardiopulmonary bypass were randomized into either oxygenator group. The endpoints included measuring inflammatory markers at six different time points (preoperative baseline, CPB circuit being primed, 15 minutes after CPB initiation, status post protamine administration, prior to transport to intensive care unit, and within 12 to 24 hours post surgery), blood product utilization, extubation time, and days until discharge. The inflammatory mediators showed no significant differences between oxygenators at any time points. However, looking at the inflammatory mediators of both the FX and RX groups combined, a statistically significant difference was seen in interleukin (IL)-6 at 12/24 hour post surgery (p < .001) versus baseline and all other time points. IL-8 at status post protamine (p < .001) and 12/24 hours post surgery (p < .001) demonstrated significant differences versus all other time points, and IL-10 at status post protamine (p < .001) and prior to leaving the operating room (p < .001) were statistically different compared to all other time points. Cardiopulmonary bypass stimulates the systemic inflammatory response through various components of the extracorporeal system. This investigation did not find significant differences in cytokines interferon-gamma, IL-1beta, IL-2, IL-4, IL-5, IL-6, IL-8, IL-10, IL-12 p70, tumor necrosis factor (TNF)-alpha, and TNF-beta when comparing these two oxygenators. It is well known that various mechanisms contribute to the levels of cytokines circulating in a patient's blood volume and many manipulations throughout cardiac surgery have the ability to demonstrate anti-inflammatory interventions. Further investigation is needed as to how modification of the extracorporeal circuit may minimize increases in inflammatory mediators. KEYWORDS: infant, bypass, cytokines, blood, infant perfusion strategy.

RCT Entities:   Population Interventions Outcomes