Immodin in the treatment of immunoparalysis in intensive care patients]

The objective of the study was to evaluate the effect of administration of the immunoregulating preparation Immodin (Sevapharma, CZ) to influence immunoparalysis in intensive care unit patients.A double blind, randomised clinical study was designed for the above purpose. The patients in whom immunoparalysis was detected during monitoring (CD14+ HLA-DR+ < or = 40 %) were randomised for the administration of Immodin (IM) or placebo (PL); the treatment lasted for 5 days. 45 (25% of all monitored) patients - the men/women ratio being 29/16, 60 (54; 65) years of age - were enrolled in the study (of which 25 IM and 20 PL).The patients did not show differences in ICU mortality - 23 IM patients survived, 2 IM patients died; 15 PL patients survived and 5 PL patients died (p = 0.214). The time of ICU hospitalisation did not differ, either - 11.6 days for IM patients (8.2; 14.9), 12.6 days for PL patients (9.1; 16.1) (P = 0.659) - nor did the number of nosocomial infections - 4 out of 25 IM patients and 4 out of 20 PL patients (p = 0.776). No difference was observed between the patient groups during a 5 day intervention period in terms of SOFA score development (p = 0.954), SIRS days (p = 0.614), sepsis or severe sepsis (respectively p = 0.451 and p = 0.250). No difference was recorded in the trends of basic immunologic parameters, either (CD14+ HLA-DR+ - p = 0.460, production of TNFalpha - p = 0.802, IL-6 - p = 0.335 , IL-10 - p = 0.226). The trend of inflammation parameters was also identical (CRP - p = 0.673, PCT - p = 0.711 ).The effect of 5 day administration of Immodin to ICU patients with symptoms of immunoparalysis does not differ from that of placebo.