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Prevention of infection in multiple trauma patients by high-dose intravenous immunoglobulins
Douzinas EE, Pitaridis MT, Louris G, Andrianakis I, Katsouyanni K, Karmpaliotis D, Economidou J, Syfras D, Roussos C
Critical Care Medicine. 2000;28((1):):8-15.
Abstract
OBJECTIVE To investigate the activity of intravenous immunoglobulin (IVIG) as a prophylactic agent against infection in trauma victims. DESIGN Prospective, randomized, double-blind, placebo-controlled study. SETTING A 20-bed university intensive care unit. PATIENTS Thirty-nine trauma patients with injury severity scores (ISSs) of 16-50. INTERVENTIONS Penicillin was given at the time of admission and continued at least until day 4. Twenty-one patients received IVIG and 18 patients received human albumin at 1 g/kg in four divided doses (days 1, 2, 3, and 6). The two groups had similarities in age, gender, Acute Physiology and Chronic Health Evaluation II score, risk of death, and Glasgow Coma Scale score, but differing ISSs (p = .02), at the time of admission. Blood was collected on days 1, 4, and 7. MEASUREMENTS AND MAIN RESULTS Clinical variables related to infection were recorded. The complement components C3c, C4 and CH50, IgG, and the fractions of IgG were measured. The serum bactericidal activity (SBA) was assessed at 37 degrees C (98.6 degrees F) and 40 degrees C (104.0 degrees F) at the time of admission and during the course of IVIG administration. Controlling for ISS, IVIG-treated patients had fewer pneumonias (p = .003) and total non-catheter-related infections (p = .04). Catheter-related infections (p = .76), length of stay in the intensive care unit, antibiotic days, and infection-related mortality did not differ between the two groups. A significantly increased trend in IgG and its subclasses was shown on days 4 and 7 in the IVIG group but not in the control group (p<.000001). No important differences were noted in complement fractions. The SBA of the groups was similar on day 1, but significantly higher on days 4 and 7 (p<.000001) in the IVIG group, remaining so controlling for complement and ISS. SBA was higher at 40 degrees C (104.0 degrees F) compared with 37 degrees C (98.6 degrees F) (p<.0001) under all three conditions. In both groups, low SBA (on days 1, 4, and 7) was associated with increased risk of pneumonia (p<.01) and non-catheter-related infections (p = .06 for day 1; p<.01 for days 4 and 7). CONCLUSIONS Trauma patients receiving high doses of IVIG exhibit a reduction of septic complications and an improvement of SBA. Early SBA measurement may represent an index of susceptibility to infection.
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2.
Safety and efficacy of intravenous immunoglobulin prophylaxis in pediatric head trauma patients: a double-blind controlled trial
Gooding AM, Bastian JF, Peterson BM, Wilson NW
Journal of Critical Care. 1993;8((4):):212-6.
Abstract
Infection is one of the major complications of severe head trauma in children. To assess whether intravenous immunoglobulin (IVIg) decreases the incidence of secondary infection after head injury in children, a randomized, double-blind trial was performed. Thirty-three children (mean age, 6.67 years; mean injury severity score, 32.8; mean Glasgow coma score, 6.1) with severe head injuries were enrolled; 1 child was excluded, 18 received IVIg, and 14 received the placebo preparation. Four hundred milligrams per kilogram of IVIg or albumin placebo was administered within 48 hours of admission. IgG levels were obtained before the infusion and then 1 week later. Patients were monitored for evidence of infection for the next 21 days. There was a 66% increase in mean IgG levels in the treatment group compared with 45% in the control group (P = .057). One death occurred in the IVIg group and two in the placebo group. No significant differences in the incidence of pneumonia, sepsis, presumed sepsis, or any other type of infection was noted. There was no difference in the number of days on mechanical ventilation or in number of hospital days. There were no side effects. It is concluded that prophylactic administration of commercial IVIg at a dose of 400 mg/kg, although safe, had no effect on the incidence of secondary infections in children with severe head injuries.
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Prevention with pseudomonas immune globulin in burn injury patients with inhalation trauma: does it have an effect on lung function and outcome? German
Stuttmann R, Hebebrand D, Hartert M, Spilker G, Doehn M
Klinische Wochenschrift. 1991;69(Suppl 26):168-77
Abstract
In an evaluation of the effect of prophylactic application of Pseudomonas immunoglobulin on the immunoglobulin serum concentration, infection rate, lung function and mortality in major burn-trauma patients, a clinical, prospective, controlled and randomized trial along with an extensive literature review was carried out in the intensive care unit (ICU) of a major burn-trauma center at a major municipal hospital in the Federal Republic of Germany. A total of 60 patients suffering from major burn trauma were studied. Some of them exhibited inhalation injury as a secondary trauma. Inclusion criteria comprised an age of 15-60 years, burns covering 30%-70% of the body surface area, and second and third degree skin burns. In a randomized fashion, the consecutively admitted patients were assigned to either the study or the control group, each comprising 30 subjects. Study-group patients (PIG-GRP) received 250 mg/kg Pseudomonas immunoglobulin (Psomaglobin; Tropon-Cutter, Cologne, FRG) intravenously on days 3, 5, 7, 10 and 13 following the trauma, whereas controls (CON-GRP) received no prophylaxis. The immunoglobulin concentration was measured in serum on days 1, 3, 5, 7, 10, 13, 16, 19 and 28. From day 3 to day 13, significant higher values were found in study-group patients; however, this held true only for that subgroup of subjects in each group who displayed additional inhalation injury (PIG-SUBGRP = 23; CON-SUBGRP = 16). Immunoglobulin serum levels showed an earlier return to normal in the PIG-SUBGRP (day 7) than in the CON-SUBGRP (day 13). Blood cultures were taken on suspicion of septicaemia. In the above-described subgroups, the number of positive blood cultures was significantly reduced in the study patients (PIG-SUBGRP, 27 bacteremic subjects among a total of 70; CON-SUBGRP, 22 among a total of 36; P = 0.0045). In all, 21 subjects in the PIG-SUBGRP and 13 patients in the CON-SUBGRP were mechanically ventilated according to an adaptive scheme. The target value of pulmonary function was the O2 quotient (P(ALV)O2-P(ART)O2/P(ALV)O2), which was significantly closer to the normal value in the PIG-SUBGRP. Mortality was lower in the PIG-SUBGRP (34.8%, 8 patients) than in the CON-SUBGRP (50%, 8 subjects). In conclusion, prophylaxis with Pseudomonas immunoglobulin does not appear to be beneficial to burn trauma patients in general; however, it was shown to be effective in burn-trauma patients exhibiting inhalation injury.
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Polyvalent immunoglobulins for prophylaxis of bacterial infections in patients following multiple trauma. A randomized, placebo-controlled study
Glinz W, Grob PJ, Nydegger UE, Ricklin T, Stamm F, Stoffel D, Lasance A
Intensive Care Medicine. 1985;11((6):):288-94.
Abstract
One hundred and fifty severely injured patients requiring long-term artificial ventilation were evaluated in a prospective, randomized, double blind study comparing the prophylactic effect of an intravenous immunoglobulin (Sandoglobulin; IGIV) against nosocomial infections with a placebo preparation. The groups were comparable in age, sex, injury pattern, and severity of the trauma. Seventy-six patients received 12 g of Sandoglobulin as a 3% solution on day 0, day 5 and day 12, i.e. a total of 36 g. Sandoglobulin significantly reduced the incidence of pneumonia (28 cases in the IGIV group, 43 cases in the placebo group, p = 0.0111). This resulted in a reduced therapeutic use of antibiotics. For the occurrence of sepsis (IGIV: 14 cases; placebo 19 cases) and other infections (IGIV: 11 cases; placebo: 10 cases) no significant differences were found. No side effects of the administration of IGIV were observed. IGIV prophylaxis neither reduced the overall death rate nor those deaths caused by infection. On day 5 after administration of the first 12 g of IGIV, the IgG serum concentrations were significantly higher in the Sandoglobulin group (8.41 +/- 1.96 mg/ml and 7.42 +/- 2.25 mg/ml respectively, p less than 0.001) whereas later serum samples showed no significant differences.
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5.
Immunoglobulin changes after varied resuscitation regimens
Faillace DF, Ledgerwood AM, Lucas CE, Kithier K, Higgins RF
Journal of Trauma-Injury Infection & Critical Care. 1982;22((1):):1-5.
Abstract
Prior studies showed that albumin supplementation of the resuscitation for hypovolemic shock caused an increase in serum albumin but a fall in serum globulins; immunoglobulins were not measured. Using frozen sera, immunoglobulins (IgG, IgM, IgA, IgD) were measured in 184 severely injured patients including 40 patients prospectively randomized for supplemental steroid therapy and 46 patients prospectively randomized for supplemental albumin therapy. The remaining patients served as the control patients. Compared to normal, the control patients had a significant reduction in IgG, IgM, and IgA. This reduction was associated with a fall in total serum proteins and serum albumin concentrations. Supplemental albumin resulted in an increase in the serum albumin concentration but a reciprocal fall in the serum globulin fraction and in IgG, IgM, and IgA. The serum proteins and immunoglobulins in the steroid patients were significantly below normal but similar to that seen in the control patients. The reduction in serum proteins and immunoglobulins in the control and steroid patients paralleled the shock time (systolic pressure below 80 mm Hg) and the amount of plasma given during resuscitation. These correlations were not significant in the albumin- supplemented patients. These data indicate that albumin supplementation alters the normal immunoglobulin response to shock. These changes in the postinjury recovery period need further study.