title: Effects of high-dose of intravenous immunoglobulin and antibiotics on survival for severe sepsis undergoing surgery.
abstract: The objective of this study was to assess the impact on outcome of adjuvant therapy (high-dose of immunoglobulin [Ig] M-enriched intravenous Ig, IVIG) in intensive care unit (ICU) patients who underwent surgery by abdominal sepsis. This was a prospective, randomized, double-blind, controlled study set in the medical/surgical ICUs of seven teaching hospitals. Patients with severe sepsis and septic shock of intra-abdominal origin admitted to the ICU within 24 h after the onset of symptoms were included in the study. Polyvalent IgM-enriched Ig (Pentaglobin; IVIG group) at a dosage of 7 mL/kg/day for 5 days or an equal amount of 5% human albumin (control group) was randomized. Fifty-six patients were enrolled. The overall mortality rate was 37.5.%. Twenty patients had shock and 36 had severe sepsis (the mortality rate was 55.0% and 25.0%, respectively). In the intent-to-treat analysis, the mortality rate was reduced from 48.1% in patients treated with antibiotic (ATB) plus albumin to 27.5% (P = 0.06) for patients with ATB plus IVIG. The organ failure score (1.0 +/- 0.6 vs. 1.2 +/- 0.9), organ dysfunction score (1.7 +/- 1.1 vs. 1.8 +/- 1.0), and reoperation rate (17.2% vs. 29.6%) were not different between IVIG and control groups, respectively. Eight patients (14.3%) received inappropriate ATB initial therapy (IAT), and seven died (87.5%). IAT was the only variable independently associated with death (odds ratio, 19.4) in a logistic regression model. We conclude that IVIG administration, when used in combination with adequate antibiotics, improved the survival of surgical ICU patients with intra-abdominal sepsis. The initial choice of antibiotic has a dramatic impact on outcome.
authors.affiliation: Intensive Care Department of Joan XXIII University Hospital/University Rovira and Virgili and Institut Pere Virgili, Tarragona, Spain. ahr1161@hotmail.com
authors.forename: Alejandro
authors.initials: A
authors.lastname: Rodríguez
authors.forename: Jordi
authors.initials: J
authors.lastname: Rello
authors.forename: Jorge
authors.initials: J
authors.lastname: Neira
authors.forename: Bernardo
authors.initials: B
authors.lastname: Maskin
authors.forename: Daniel
authors.initials: D
authors.lastname: Ceraso
authors.forename: Leonardo
authors.initials: L
authors.lastname: Vasta
authors.forename: Fernando
authors.initials: F
authors.lastname: Palizas
mesh_terms: D018806:APACHE; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000418:Albumins / Q000378:metabolism; D000900:Anti-Bacterial Agents / Q000008:administration & dosage / Q000494:pharmacology*; D003422:Critical Care; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007075:Immunoglobulin M / Q000737:chemistry / Q000627:therapeutic use; D016756:Immunoglobulins, Intravenous / Q000008:administration & dosage / Q000494:pharmacology*; D007249:Inflammation; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D009102:Multiple Organ Failure / Q000188:drug therapy; D011446:Prospective Studies; D011897:Random Allocation; D018805:Sepsis / Q000188:drug therapy* / Q000401:mortality* / Q000601:surgery; D013997:Time Factors
chemical_list: D000418:Albumins; D000900:Anti-Bacterial Agents; D007075:Immunoglobulin M; D016756:Immunoglobulins, Intravenous