ASAIO journal : a peer-reviewed journal of the American Society for Artificial Internal Organs
-
Randomized Controlled Trial
Reducing the effects of the systemic inflammatory response to cardiopulmonary bypass: can single dose steroids blunt systemic inflammatory response syndrome?
The use of cardiopulmonary bypass (CPB) is associated with the development of a significant systemic inflammatory response syndrome (SIRS) which can affect patient outcomes. Multiple pathways are involved in initiating and maintaining SIRS. We studied whether a single dose of steroids (dexamethasone) after the induction of anesthesia could blunt the SIRS from CPB. ⋯ A single dose of dexamethasone reduces IL-6 and PNE levels associated with CPB. Despite the significant reductions in IL-6 and PNE, there was no effect on clinical outcomes. Additional studies are needed to demonstrate a clinically significant effect on patient outcomes.
-
Dual missions of the Center for Devices and Radiological Health at the Food and Drug Administration (FDA) are 1) promoting public health by promptly reviewing and taking appropriate, timely action regarding the marketing of regulated medical devices while at the same time, and 2) protecting public health by ensuring a reasonable assurance of the safety and effectiveness of medical devices deemed appropriate for human use. In the past, clinicians have used cardiac assist devices intended for adults to treat pediatric heart failure patients. However, because of the larger size of the approved devices, many pediatric patients are underserved by this approach. ⋯ FDA believes that clinical data used to support such safety and probable benefit may be derived from a small focused clinical trial in this target population, and developers may want to consider this approach for approval of the humanitarian device exemption application. Pediatric device development is challenging and early communication with FDA to develop an appropriate regulatory and scientific pathway for device submission is advised and warranted. This early interaction can facilitate the development of a small but necessary trial for these life-sustaining pediatric cardiac assist devices.
-
Polymyxin B-immobilized fiber (PMX-F) hemoperfusion is reported to be safe and effective in septic shock patients. Because atrial natriuretic peptide (ANP) and brain natriuretic peptide (BNP) may have pathophysiologic significance in the cardiac dysfunction of septic shock patients, we conducted a study to determine whether PMX-F treatment affects plasma ANP and BNP levels in patients with septic shock. Fifty septic shock patients (34 men and 16 women; mean age 60.0 years) and 30 healthy volunteers (18 men and 12 women; mean age 56.0 years) were included in this study. ⋯ After the second PMX-F treatment, plasma levels of endotoxin (p < 0.01), IL-6 (p < 0.01), ANP (p < 0.01), and BNP (p < 0.01) were reduced significantly. Values decreased further the following day. Both plasma ANP and BNP levels are increased in septic shock patients and PMX-F treatment is effective in reducing these natriuretic peptide levels.