Evaluating the effect of new remedy IMOD (Imunomodulating Drug)in the treatment of adult patients with sever sepsis

Sepsis is one of the greatest medical problems in over the worlds. Unfortunately nowadays despite all technical and therapeutic progresses (mechanical ventilation, nutritional support, antimicrobial therapies, hemodialysis, vasopressor support, surgical ways,...) mortality due to sepsis is not changed. IMOD(Imunomodulating Drug) is a new remedy drug which increases(count differentiation) CD4 significantly in patients with AIDS(Acquired immunodefiency syndrome).IMOD has strong anti inflammatory effects and induces immune system without any significant side effect. So we decided to evaluate the effect of this drug in improvement of patients with severe sepsis. In this study 30 patients with severe sepsis(Acute Physiologic And Chronic Health Evaluation score>20) were randomized to two 15 patients group, which receive standard treatment of sepsis including early goal directed resuscitation, appropriate diagnostic study, early broad spectrum antibiotics, narrowing antibiotic based on microbial and clinical data, stress dose steroid for septic shock, target Hemoglubin value of 7-9 gram/dlit in absence of CAD(coronary Artey Disease) or acute hemorrhage, Lung protective ventilation for ALI(Acute Lung Injury), avoidance of neuromuscular blockade, blood glucose<140,DVT(Deep Vein Thrombosis)/Stress ulcer prophylaxis. Routine lab exams and monitoring was performed for all patients daily till 14 days. Demographic data were noted. IMOD group received IMOD with the dosage of 10mililitre/day(infusion during one hour) via Central venous line in addition to standard treatment for 14 days. Biomarker levels were measured on the 1st, 2nd, 3rd, 5th and 14th days. These biomarkers are TNF(Tumor necrosis Fator), IL-1(Interleukin-1),IL-6(Interleukin-6),nitrite and nitrate, PAI-I(Plasminogen Activator Inhibitor), Total neutrophil count, Total antioxidant power, D dimer. In the IMOD group mean time between initiation of the signs of sepsis and initiation of IMOD was noted (with 6 hours interval) in order to see whether early infusion of drug decrease mortality or not. patients observed for 28 days(672 hours after initiation of IMOD)or till death. Mortality due to any causes after 28 days and also mortality during 90 days were determined. We determined morbidity of patient during study with using following scoring system: TISS score(Therapeutic Intervention Scoring System) for evaluating the intensity of ICU9Intensive Care Unit) care, SOFA score(Sequential Organ Failure Assessment) for determining organ dysfunction, ADL score(Activity of Daily Living) for determining activities of daily living. These scoring system were performed on the recovered patients in each group.