Shock : molecular, cellular, and systemic pathobiological aspects and therapeutic approaches : the official journal the Shock Society, the European Shock Society, the Brazilian Shock Society, the International Federation of Shock Societies
-
Randomized Controlled Trial Clinical Trial
Modulating IL-6 and IL-10 levels by pharmacologic strategies and the impact of different extracorporeal circulation parameters during cardiac surgery.
Postoperative morbidity after coronary artery bypass grafting (CABG) using cardiopulmonary bypass (CPB) can be influenced by pro- and anti-inflammatory cytokines like interleukin 6 (IL-6) and IL-10 triggering and balancing the acute phase response. The extent of cytokine release can be modulated by different methods. This prospective randomized study examines the effect of treatment of patients with steroid (group 1, 250 mg of prednisolone)(Solu-Decortin H)), aprotinin (group 2, 6 Mio. ⋯ An inverse relationship was found for IL-10 (IL-6) levels and venous O2 saturation (SvO2), and mean arterial pressure (MAP). Hypothermia (<34 degrees C) reduced IL-10 and IL-6 release, whereas long duration of hypothermia correlated with higher IL-10 and IL-6 release. Cytokine release after extracorporeal circulation (ECC) can be modulated pharmacologically and by distinct perfusion regimen.
-
Randomized Controlled Trial Multicenter Study Clinical Trial
Decreased organ failure in patients with severe SIRS and septic shock treated with the platelet-activating factor antagonist TCV-309: a prospective, multicenter, double-blind, randomized phase II trial. TCV-309 Septic Shock Study Group.
Sepsis and organ failure remain the main cause of death on the ICU. Sepsis is characterized by a severe inflammatory response, in which platelet-activating factor (PAF) is considered to play an important role. This study investigated whether treatment with the PAF-antagonist TCV-309 reduces morbidity and mortality in patients with septic shock. ⋯ Furthermore, the mean APACHE-II score during treatment with TCV-309 was significantly lower and the number of patients recovered from shock after day 14 was significantly higher in the TCV-309 treated patient group (2/32 vs. 9/29, P = 0.01). The number of adverse events was not significantly different between the TCV-309 and placebo treated patients. TCV-309 did not change overall mortality of septic shock, however a substantial reduction in organ dysfunction and morbidity, frequently associated with septic shock was achieved, without significant adverse events.
-
Randomized Controlled Trial Comparative Study Clinical Trial
Health care resources consumed to treat postoperative infections: cost saving by perioperative immunonutrition.
The objectives of the study were to calculate the costs of postoperative complications and to evaluate whether the use of perioperative enteral immunonutrition, may lead to a saving in health care resources consumed. The economic analysis was based on data from a randomized double-blind trial that include 206 cancer patients who received perioperatively either enteral immunonutrition (treatment group, n = 102) or a standard enteral diet (control group, n = 104). Estimates of costs were based on resource use for treatment of complications, which were valued according to the National List of Sanitary Costs of the Italian Ministry of Health and on the medical Diagnosis-Related-Group (DRG) reimbursement rates. ⋯ Effectiveness was 83.3% in the treatment group versus 68.3% in the control group (P = 0.009). Cost effectiveness analysis showed a net saving of 2,386 euros per complication-free patient in favor of the treatment group. In conclusion, the perioperative use of immunonutrition appears cost effective due to a substantial saving of resources used to treat postoperative complications.
-
Randomized Controlled Trial Comparative Study Clinical Trial
Biobrane improves wound healing in burned children without increased risk of infection.
A synthetic bilaminar membrane used as a skin substitute (Biobrane) has been shown to decrease pain and hospitalization in superficial second-degree burns. Despite these benefits, it has not been utilized universally, particularly in young children, due to a perceived increase in related infections. We propose that when this synthetic membrane is applied to superficial scald burns <25% of the total body surface area (TBSA), decreased healing times are expected without increased risk of infection. ⋯ Treatment groups were not different in the use of systemic antibiotics or readmissions for infectious complications. Biobrane was removed in 5.9% of cases for non-adherence. The application of Biobrane within 48 h of superficial burns provides for shorter hospitalizations and faster healing times in children of all ages without increased risk of infection.
-
Randomized Controlled Trial Multicenter Study Clinical Trial
Prospectively validated prediction of organ failure and hypotension in patients with septic shock: the Systemic Mediator Associated Response Test (SMART).
Conventional outcomes research provides only percentage risk categories that are not applicable to individual patients, and it predicts only mortality, utilization of resources and/or broad groupings of multiple organ system dysfunction. The purpose of the present study was to determine whether or not the Systemic Mediator Associated Response Test (SMART) methodology could identify interactions among demographics, physiologic parameters, standard hospital laboratory tests, and circulating cytokine concentrations to predict continuous and dichotomous dependent clinical variables, in advance, in individual patients with septic shock and to integrate these into prospectively validated models. Two hundred forty (240) patients with septic shock who were entered into the placebo arm of a multi-institutional clinical trial were randomly separated into a model building training cohort (n = 154) and a predictive cohort (n = 86), which was used to prospectively validate the prognostic models built upon the training cohort database. ⋯ For hematologic/coagulation models, 37/56 (66%) up to seven days had r > 0.900. Among dichotomous models, ROC AUC > 0.700 was achieved in 30/49 (61%) during the first week. SMART integration of demographics, bedside physiology, hospital laboratory tests, and circulating cytokines predicts organ failure and physiologic function indicators in individual patients with septic shock.