Soluble human complement receptor 1 limits ischemic damage in cardiac surgery patients at high risk requiring cardiopulmonary bypass.

BACKGROUND: This study was undertaken to determine whether soluble human complement receptor type 1 (TP10), a potent inhibitor of complement activation, would reduce morbidity and mortality in high-risk patients undergoing cardiac surgery on cardiopulmonary bypass (CPB). METHODS: This was a randomized multicenter, prospective, placebo-controlled, double-blind study in which 564 high-risk patients undergoing cardiac surgery on CPB received an intravenous bolus of TP10 (1, 3, 5, 10 mg/kg) or placebo immediately before CPB. The primary endpoint was the composite events of death, myocardial infarction (MI), prolonged (> or =24 hours) intra-aortic balloon pump support (IABP), and prolonged intubation. RESULTS: TP10 significantly inhibited complement activity after 10 to 15 minutes of CPB and this inhibition persisted for 3 days postoperatively. However, there was no difference in the primary endpoint between the 2 groups (33.7% placebo versus 31.4% TP10; P=0.31). The primary composite endpoint was, however, reduced in all male TP10 patients by 30% (P=0.025). TP10 reduced the incidence of death or MI in males by 36% (P=0.026), the incidence of death or MI in CABG males by 43% (P=0.043) and the need for prolonged IABP support in male CABG and valve patients by 100% (P=0.019). There was, however, no improvement seen in female TP10 patients. There were no significant differences in adverse events between the groups. CONCLUSIONS: TP10 effectively inhibits complement activation during CPB; however, this was not associated with an improvement in the primary endpoint of the study. Nevertheless, TP10 did significantly decrease the incidence of mortality and MI in male patients.

Comparative Study of a Colorimetric DNA Hybridization Method and Conventional Culture Procedures for the Detection of Listeria spp. in Foods.

A colorimetric DNA hybridization-based assay has been evaluated against two conventional culture methods (FDA and USDA) for detection of Listeria spp. in dairy, Meat, and seafood products. A total of 1,300 samples representing 15 food types were analyzed in parallel by both the DNA hybridization (DNAH) and culture methods (FDA for dairy products and seafoods, USDA for meats). Samples included inoculated and naturally contaminated products and uninoculated controls. Fifteen strains representing five species of Listeria were used as inocula. Of 660 dairy and seafood samples tested, the FDA culture method detected 354 positives and the DNAH method detected 393 positives, 391 of which were confirmed. The DNAH method was statistically equivalent to the FDA method for eight of the nine products tested. In some trials, the DNAH method detected more positives than the FDA method for cheddar cheese and in some cases these differences were statistically significant. Of 540 meat samples tested, the USDA culture method detected 261 positives and the DNAH method detected 378 positives, all of which were confirmed. The DNAH method was statistically equivalent to the culture method for three of the six products tested. In some trials, the DNAH method detected more positives than the USDA method for roast beef, hot dogs, and fermented sausage. In some cases, these differences were statistically significant. Of 100 naturally contaminated products tested, the DNAH method detected 86 positives and the culture methods detected 84 positives. The DNAH method was statistically equivalent to the culture methods for these samples. The DNAH method gives a negative result 48 h after the start of sample enrichment, whereas the FDA and USDA methods require 3 to 4 days or longer. It is concluded that the DNAH assay is a rapid, accurate, and objective alternative to the culture procedures for the detection of Listeria spp. in foods.