title: [Immodin in the treatment of immunoparalysis in intensive care patients].
abstract: OBJECTIVE
  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.
  
  
  METHODS
  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).
  
  
  RESULTS
  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 ).
  
  
  CONCLUSIONS
  The effect of 5 day administration of Immodin to ICU patients with symptoms of immunoparalysis does not differ from that of placebo.
authors.affiliation: Anesteziologicko-resuscitacní klinika Lékarské fakulty MU a FN u sv. Anny Brno. vladimir.sramek@fnusa.cz
authors.forename: V
authors.initials: V
authors.lastname: Srámek
authors.forename: L
authors.initials: L
authors.lastname: Dadák
authors.forename: M
authors.initials: M
authors.lastname: Stouracová
authors.forename: P
authors.initials: P
authors.lastname: Stetka
authors.forename: L
authors.initials: L
authors.lastname: Komolíková
authors.forename: P
authors.initials: P
authors.lastname: Kuklínek
mesh_terms: D000276:Adjuvants, Immunologic / Q000627:therapeutic use*; D000368:Aged; D003422:Critical Care; D016638:Critical Illness; D004311:Double-Blind Method; D005260:Female; D006684:HLA-DR Antigens / Q000097:blood; D006801:Humans; D007108:Immune Tolerance / Q000187:drug effects*; D016753:Interleukin-10 / Q000097:blood; D015850:Interleukin-6 / Q000097:blood; D018950:Lipopolysaccharide Receptors / Q000097:blood; D008297:Male; D008875:Middle Aged; D018746:Systemic Inflammatory Response Syndrome / Q000276:immunology / Q000517:prevention & control; D014409:Tumor Necrosis Factor-alpha / Q000097:blood
chemical_list: D000276:Adjuvants, Immunologic; D006684:HLA-DR Antigens; D015850:Interleukin-6; D018950:Lipopolysaccharide Receptors; D014409:Tumor Necrosis Factor-alpha; D016753:Interleukin-10