2.3. Treatment
All patients were assigned to either the study group or the control group according to a number extracted at the beginning of the study from a table of random numbers generated by the Statistical Package for the Social Sciences (SPSS) version 17.0 (SPSS Inc., Chicago, IL, USA). This was done only once, and there was no subsequent modification of number assignment during the trial. The study group assignments were placed in sealed, opaque, randomly assorted envelopes. The envelope was not opened until the patient was enrolled in the trial. Patients and statisticians were both blinded to the use of safflower yellow.
Patients in the two groups received 3-hour and 6-hour bundles of conventional therapy according to the international guidelines for management of severe sepsis and septic shock 2012 [9]. Patients in the study group received intravenous injection of safflower yellow at a dose of 100 mg [19] every 12 hours for 72 hours in addition to therapy.
According to Surviving Sepsis Campaign (SSC) international guidelines for management of severe sepsis and septic shock 2012, we collected samples for the culture isolation of the pathogen in each case within 1 hour after patient’s arrival in the ICU, or within 3 hours after arrival in the emergency department.