Effect of new remedy IMOD [Immunomodulating drug ] on the mortality of patients with severe sepsis. A phase III multicenter study

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Patients in IMOD group received IMOD in addition to standard treatment. They received 5 IMOD in 100cc DW 5% which is infused over 1 hour on the first day. All hemodynamic data were noted during the time of infusion in order to stop the infusion in the case of any negative hemodynamic deterioration, dermal rash, urticaria and anaphylactic reaction. Then 10cc IMOD in 100cc DW 5% was infused everyday until day 14 of the treatment protocol. the time gap between the beginning of treatment with IMOD and the diagnosis of sepsis was also noted to evaluate possible impact of the onset time of IMOD on mortality . The control group have received the standard treatment for sepsis including:.Early goal – directed resuscitation, appropriate diagnostic studies prior to antibiotics, early broad – spectrum antibiotics ,narrowing antibiotic therapy based on microbial therapy and clinical data source control ,stress dose steroids for septic shock, target Hb values of 7-9 gr/dlit in absence of coronary artery disease or acute hemorrhage, lung protective ventilation for Acute Lung Injury/Acute Respiratory Distress Syndrome, avoidance of Neuromuscular blockade, maintenance of blood glucose < 150mg/dl and Deep Vein Thrombosis/stress ulcer prophylaxis. Inflammatory biomarkers including IL1, IL2, IL6, Tumor Necrosis Factor a ,Plasminogen Activator Inhibitor, Nitric Oxide, Total antioxidant power that were assessed on days 0, 1, 2, 3, 7, 10, 14 throughout the study.

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