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Immunoglobulin G treatment of postcardiac surgery patients with score-identified severe systemic inflammatory response syndrome--the ESSICS study
Werdan K, Pilz G, Müller-Werdan U, Maas Enrique M, Schmitt DV, Mohr FW, Neeser G, Schöndube F, Schäfers HJ, Haverich A, et al
Critical Care Medicine. 2008;36((3):):716-23.
Abstract
OBJECTIVE A minority of patients develop severe systemic inflammatory response syndrome (SIRS) with high mortality following cardiopulmonary bypass-assisted cardiac surgery. We assessed whether intravenous immunoglobulin G (ivIgG) improves postoperative short-term (5-day) morbidity and reduces 28-day mortality in these patients. DESIGN Randomized, double-blind, placebo-controlled, multicenter trial. SETTING Intensive care units of 11 cardiothoracic centers. PATIENTS AND INTERVENTIONS Of 6,984 patients screened, we identified 244 with severe SIRS (Acute Physiology and Chronic Health Evaluation II score > or = 28 on the first postoperative day). INTERVENTIONS The 244 patients with severe SIRS were randomly assigned to receive an intravenous infusion of either albumin 0. 1% (placebo group, 6 mL [6 mg]/kg of body weight on day 1 and 3 mL [3 mg]/kg of body weight on day 2) or immunoglobulin G 10% (ivIgG group, 6 mL [600 mg]/kg of body weight on day 1 and 3 mL [300 mg]/kg of body weight on day 2). MEASUREMENTS AND MAIN RESULTS The prospectively defined primary end points were improvement in morbidity on day 5 and death from any cause assessed on day 28. A total of 218 patients received both doses of the study drug (placebo n = 108, ivIgG n = 110). Acute Physiology and Chronic Health Evaluation II scores in the placebo group decreased from 31. 8 +/- 4. 0 (day 1) to 25. 8 +/- 9. 3 (day 5) and in the ivIgG group from 31. 8 +/- 3. 4 (day 1) to 25. 9 +/- 10. 3 (day 5), with no significant difference between the groups (p = . 56). The 28-day mortality rate was not significantly different between the groups (per protocol population, placebo group 31. 5%, ivIgG group 39. 1%; intent-to-treat population, placebo group 37. 2%, ivIgG group: 44. 7%). No effect of ivIgG on plasma levels of interleukin-6, tumor necrosis factor, and tumor necrosis factor receptor I/II was observed. Drug-related adverse events were rare in both groups. CONCLUSIONS Patients undergoing cardiac surgery (involving cardiopulmonary bypass) who develop severe SIRS derive no improvement in short-term morbidity or 28-day mortality from ivIgG.
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2.
IgM-enriched immunoglobulin preparation for immunoprophylaxis in cardiac surgery
Friedrich I, Silber RE, Baumann B, Fischer C, Holzheimer RG
European Journal of Medical Research. 2002;7((12):):544-9.
Abstract
OBJECTIVE Evaluating the effects of prophylactic administration of IgM-enriched immunoglobulins (IVIG) on immunological- and clinical parameters in cardiac surgical patients. PATIENTS AND METHODS 41 patients were randomized to receive either an IgM-enriched immunoglobulin (Pentaglobin(R)) preparation (1,300 ml immunoglobulin, equivalent to 65 g protein) combined with routine antibiotic prophylaxis (Group A; n = 20, 1 drop-out), or routine antibiotic prophylaxis plus placebo (Group B; n = 20). Patients were comparable with respect to their APACHE II score, comorbidity, coronary risk, operating time, clamp, and ischemic time. Endotoxin and endotoxin neutralizing capacity (ENC) were determined by a kinetic turbidimetric Limulus amebocyte lysate (LAL) assay with internal standardization. Serum levels of interleukin-6 (IL-6), tumor necrosis factor-alpha (TNF)-alpha, soluble TNF-Receptor I (sTNF-R1), and interleukin-10 (IL-10) were determined by ELISA. Data analysis was performed by area under the curve (AUC) calculation and ANOVA for endotoxin neutralizing capacity and by ANOVA for all other cases. RESULTS All patients survived. Endotoxin plasma levels were generally but not significantly higher in group A than in controls, while the difference in endotoxin neutralizing capacity (ENC) reached significance. IL-6, TNF-alpha, IL-10 and TNF-R1 were not different between both groups, however. There were significantly less patients with signs of inflammation (fever, leukocytosis, hypotension) in group A (group A n = 2; group B n = 9; p<0.05). This was paralleled by a slightly reduced hospitalization period in group A patients compared to group B patients (A:12.05 +/- 3.66 vs. B:13.45 +/- 3.72 days; n.s.). All data are given as mean +/- standard deviation (SD). CONCLUSION The results of this study support that IgM-enriched IVIG preparation are effective when used prophylactically in patients undergoing procedures with cardiopulmonary bypass. The mechanisms of endotoxin neutralization and the effect of the host immune status on the efficacy of IVIG treatment remain to be elucidated.
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3.
A multicentre randomised placebo-controlled double-blind study on adjuvant treatment of mediastinitis with immunoglobulins (Pentaglobin) after cardiac surgery (ATMI): outline and preliminary study protocol for discussion. The ATMI Study Group
Marggraf G, Neugebauer EA
European Journal of Surgery, Acta Chirurgica, Supplement. 1999;165((S9):):26-32.
Abstract
UNLABELLED We present the second draft of a consensus-assisted protocol on the adjuvant treatment after cardiac surgery with immunoglobulins of mediastinitis. CLINICAL PHASE Phase III. OBJECTIVE OF THE STUDY Placebo-controlled investigation of the clinical efficacy of Pentaglobin (Biotest, Germany) as an added treatment in patients with mediastinitis. MEDICATION Group A, active Pentaglobin; Group B, placebo: 5% glucose solution with 1% human albumin. DOSAGE 5 ml/kg body weight Pentaglobulin or placebo intravenously each day for 5 days. STUDY DESIGN Prospective, placebo-controlled, double blind, randomised, multicentre. SAMPLE SIZE n = 100; 50 patients with Pentaglobin (active), 50 patients with placebo. PRIMARY OUTCOME MEASURE Cumulative therapeutic intervention scoring system (TISS-28) during hospital stay.
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Reduced incidence of postoperative infection after intravenous administration of an immunoglobulin A- and immunoglobulin M-enriched preparation in anergic patients undergoing cardiac surgery
Kress HG, Scheidewig C, Schmidt H, Silber R
Critical Care Medicine. 1999;27((7):):1281-7.
Abstract
OBJECTIVE To evaluate the efficacy of a commercial immunoglobulin (Ig) A- and IgM-enriched immunoglobulin preparation containing high antibody titers against various human pathogens in the prevention of postoperative infections in anergic patients undergoing cardiac surgery. DESIGN A single-center, prospective, double-blind, randomized study comparing the effect of a polyvalent intravenous human immunoglobulin (IVIG) preparation vs. placebo. LOCATION OF THE STUDY Institute of Anesthesiology and Department of Thoracic and Cardiovascular Surgery, University Hospital, Wurzburg, Germany. PATIENTS A total of 515 patients awaiting elective open-heart surgery with the aid of cardiopulmonary bypass were tested for their in vivo immune response to intradermally administered recall antigens. Forty patients who were preoperatively shown to be anergic in this skin test, and therefore at high risk of developing serious postoperative infections, were selected from this group. Twenty patients with normal immune responses, and thus having a normal risk of infection, were randomly selected from the same patient group to serve as an immunoreactive control group. INTERVENTIONS After obtaining approval from the local institutional review board and informed consent from patients, the 40 anergic patients were randomized and assigned either to the IVIG group (n = 19), to receive a commercially available human IgA- and IgM-enriched immunoglobulin preparation (dose, 20 g), or to the placebo group (n = 21), to receive physiologic saline. These treatments were started 4 hrs after surgery as a 400-mL continuous infusion over a period of 53 hrs. Patients were observed for the development of postoperative infection for the next 2 wks. Group comparisons were made using repeated-measures analysis of variance and Fisher's exact test. A p value < .05 was considered statistically significant MEASUREMENTS AND MAIN RESULTS Postoperative infections were detected in nine of 21 patients (43%) in the placebo group but in only one of 19 patients (5%) in the IVIG-treated group (p = .007; Fisher's exact test). Three of the 20 patients (15%) with normal immune response who received standard postoperative treatment developed postoperative infections. CONCLUSIONS A commercially available IgA- and IgM-enriched intravenous immunoglobulin preparation administered immediately after cardiac surgery significantly reduced the incidence of postoperative infections in preoperatively anergic patients.
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5.
Comparison of early IgM-enriched immunoglobulin vs polyvalent IgG administration in score-identified postcardiac surgical patients at high risk for sepsis
Pilz G, Appel R, Kreuzer E, Werdan K
Chest. 1997;111((2):):419-26.
Abstract
STUDY OBJECTIVE To address the relevance of the IgM component in polyvalent immunoglobulins in sepsis treatment by comparison of the clinical course under polyvalent IgG vs IgGMA therapy in postcardiac surgical patients at high risk for sepsis and to reassess the prognostic validity of sequential changes in acute physiology and chronic health evaluation (APACHE II) scores during treatment. DESIGN Prospective, randomized clinical trial. SETTING Cardiac surgical ICU in a university hospital. PATIENTS Among 870 consecutive patients after elective open-heart surgery, 29 (3.3%) met the previously validated high-risk criterion (APACHE II score > or = 24 on the first postoperative day) with a mean APACHE II score-predicted mortality risk of 63%. INTERVENTIONS In addition to standard therapy, 27 of these patients were randomized to receive commercially available IV IgG (Polyglobin N, n = 14, total dosage: 18 mL/kg) or IgGMA (Pentaglobin, n = 13, total dosage: 15 mL/kg). MEASUREMENTS AND RESULTS The two groups were comparable in baseline disease severity and concurrent therapy. The extent of score-quantified improvement in disease severity during treatment was similar in both groups (mean fall in APACHE II scores within 4 days; IgG, -6.9; IgGMA, -5.2), as were score-defined improvement rates (rate of patients with score decrease > or = 7 within 4 days: IgG, 57%; IgGMA, 54%) and in-hospital mortality (IgG, 29%; IgGMA, 31%) (all p = NS). There was a strong association between the decrease over time in APACHE II scores during therapy and prognosis (mortality rates in patients with vs without score-assessed improvement: 0% vs 67%, p = 0.0002). CONCLUSIONS IgG and IgGMA were associated with a comparable improvement in disease severity in score-identified postcardiac surgical patients at high risk for sepsis. Given the design as an efficacy rather than an equivalence study, this hypothesis derived from our results needs independent validation in larger trials. Sequential APACHE II score changes were reconfirmed as a prognostically valid quantitative measure of disease progress during sepsis therapy.
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Prospective randomized trial of efficacy of ganciclovir versus that of anti-cytomegalovirus (CMV) immunoglobulin to prevent CMV disease in CMV-seropositive heart transplant recipients treated with OKT3
Aguado JM, Gomez-Sanchez MA, Lumbreras C, Delgado J, Lizasoain M, Otero JR, Rufilanchas JJ, Noriega AR
Antimicrobial Agents & Chemotherapy. 1995;39((7):):1643-5.
Abstract
We compared the efficacy of ganciclovir versus that of cytomegalovirus (CMV) immunoglobulin for the prevention of CMV disease in 31 CMV-seropositive heart transplant recipients who had received early immunoprophylaxis with OKT3 monoclonal antibodies. The incidence of CMV disease and visceral involvement was much higher in the CMV immunoglobulin group than in the ganciclovir group (40 versus 6%, respectively; P = 0.03). No adverse effects were found in the CMV immunoglobulin group, but 19% of the patients in the ganciclovir group developed mild leukopenia or a mild increase in their serum creatinine levels.
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Prevention of post-transfusion non-A, non-B hepatitis by non-specific immunoglobulin in heart surgery patients
Sanchez-Quijano A, Pineda JA, Lissen E, Leal M, Diaz-Torres MA, Garcia De Pesquera F, Rivera F, Castro R, Munoz J
Lancet. 1988;1((8597):):1245-9.
Abstract
To evaluate the effectiveness of immune serum globulin (ISG) in preventing non-A, non-B hepatitis, 291 heart surgery patients who received blood from voluntary donors were randomly assigned to receive either ISG or no additional protection. ISG was given intramuscularly before and 1 week after transfusion. 98 controls and 100 in the ISG group completed the study. Post-transfusion non-A, non-B hepatitis developed in 11 (11.2%) controls but in only 3 (3.0%) of the ISG group (p = 0.0203). 8 (72.7%) of control group with hepatitis had symptoms, and in 5 (45.4%) the disease became chronic. The disease was self-limiting in all 3 ISG patients affected, and only 1 of them had symptoms. Among those with non-A, non-B hepatitis aminotransferase levels were higher in the controls than in the ISG patients. Incubation periods longer than 8 weeks correlated with a tendency for the disease to become chronic. ISG recipients had shorter as well as more homogeneous incubation periods. ISG could be a safe, low-cost means for preventing post-transfusion non-A, non-B hepatitis which does not call for the discarding of donated blood.
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8.
Prophylaxis of postoperative infections after open-heart surgery by administration of human pepsinated immunoglobulin
Lozano R, Navarro M, Pastor C, Suarez J, Salinas JC, Revilla JM, Sainz M, Roman A, Abos MD
Arzneimittel-Forschung. 1986;36((10):):1535-9.
Abstract
The present controlled study examines the effect of intravenously administered human pepsinated immunoglobulin G (HPIG, Gamma-Venin) on the postoperative incidence of infections in patients undergoing heart surgery supported by extracorporeal circulation. This particular form of surgery normally produces markedly diminished serum IgG levels, but the results of the study showed that these recovered more rapidly after treatment with HPIG. A statistically significant difference in the number of infections between the group treated with HPIG and the control group (p less than 0.05) was found. It may be concluded that, with regard to postoperative infection, patients undergoing open-heart surgery may benefit from the administration of HPIG.
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9.
Passive prophylactic immunisation against post-transfusion hepatitis by immunoglobulin preparations: a prospective clinical study . German
Schumacher K, Maerker-Alzer G, Kleinau T, Hugel W, Dalichau H, Dienst C, Mitrenga D
Deutsche Medizinische Wochenschrift. 1982;107((39):):1459-64.
Abstract
In the course of a randomised prospective study involving 98 patients who had undergone cardiac surgery, 51 patients were given 20 g human immunoglobulin i.v. over four months, 47 received merely blood transfusions, like all other patients, averaging 4.4 units per patient. Antibodies against HBs antigen or Hbc antigen were present in 20% of patients before operation. After operation (plus blood transfusions) antibodies against hepatitis-B virus were demonstrated in 43% of the control group but 94% of those treated with immunoglobulins. These antibodies persisted in the course of further immunoglobulin administrations, while they fell in the control group. Hepatitis-B infections occurred in ten patients of the control group, after 30-90 days; three of them developed acute hepatitis. In the group treated with immunoglobulins there were only two patients with an infection, one of whom developed hepatitis. Antibodies against cytomegalic virus increased in the control group but not in the treatment group. In both groups there was the same incidence of non-A-non-B hepatitis.