D as follows: Norepinephrine was 4-(Thiophen-2-yl)pyridin-3-amine titr…
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4 ), systemic vascular PubMed ID:https://www.ncbi.nlm.nih.gov/pubmed/12711626 resistance index <1,600 dyne ?sec/cm5 per m2, and cardiac index >3.5 L/minute per m2 at 4 h, as we reported in a previous study [6]. We also recorded blood loss (chest-tube drainage and hemoderivatives) at the above time points and on chest tubes removal. In cases of reintervention due to bleeding, the post-hoc classification of bleeding into "surgical" and "non-surgical" was applied to distinguish between bleeding due to mechanical-surgical causes (where pharmacological measures are not effective) and coagulopathy (which TA was expected to reduce). Surgical risk was calculated by Euroscore and Parsonnet score.In relation to the power of the study, prior experimental information available is as follows: the proportion of IR in patients receiving 30 mg/kg in two doses was 16.6 [6]; however, we had no prior information on the expected incidence rate of IR with 80 mg/kg. In the present study, we hypothesized that the double dose of TA would reduce the inflammatory response. For expected incidences of 16.6 in the TA1 group (40-0 mg/Kg) and 3 in the TA2 group, with 80 power and 5 type one error (one-tailed), 58 patients per group were needed. Assuming 28 dropout, 80 patients were required in each treatment group. For the concurrent validation of the clinical criteria of IR, we used mixed ANOVA with repeated measures of evolutionary levels of IL-6.
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