***TASK*** the task is to summarize an input biomedical literature in six sentences 
    ***INPUT*** the input is a biomedical literature 
    ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences 
    ***DOCUMENTATION*** 
    ***EXAMPLES*** 
    Input: Introduction In this prospect i ve , r and omized controlled study , we aim ed to evaluate the effect of IgM-enriched immunoglobulin treatment on progression of organ failure and septic shock in patients with severe sepsis . Material s and methods Forty-two patients with severe sepsis were enrolled in the study . Patients in the study group ( n = 21 ) received an intravenous immunoglobulin preparation ( Pentaglobin ® ) in addition to st and ard therapy . Pentaglobin ® therapy was commenced on the day of diagnosis of severe sepsis : 5 ml/kg per day Pentaglobin ® ( 38 g/l IgG , 6 g/l IgM , and 6 g/l IgA ) was infused over 6 hours and repeated for 3 consecutive days . Patients in the control group ( n = 18 ) received st and ard sepsis therapy , but no immunoglobulin administration . Blood sample s for procalcitonin ( PCT ) measurements were taken daily for 8 days . Severity of critical illness and development of organ failure were assessed by obtaining daily acute physiological and chronic health evaluation ( APACHE ) II and sequential organ failure assessment ( SOFA ) scores . Results and discussion Procalcitonin levels showed a statistically significant decrease in the Pentaglobin ® group ( P < 0.001 ) ; however , an improvement in SOFA scores could not be demonstrated . Procalcitonin levels and SOFA scores did not change significantly in the control group . Septic shock incidence ( 38 % versus 57 % ) and 28-day mortality rate ( 23.8 % versus 33.3 % ) were found to be similar between the Pentaglobin ® and control groups . The evaluation of serial APACHE II scores did not demonstrate a difference between Pentaglobin ® and control groups either . Conclusion Present data could not demonstrate any beneficial effects of polyclonal immunoglobulin preparation Pentaglobin ® on organ morbidity , septic shock incidence and mortality rate in patients with severe sepsis Objective : Intravenous immunoglobulin as an adjunctive treatment in sepsis was regarded as promising by a Cochrane meta‐ analysis of smaller trials . In this phase III multicenter trial , we assessed whether intravenous immunoglobulin G ( ivIgG ) reduced 28‐day mortality and improved morbidity in patients with score‐defined severe sepsis . Design : R and omized , double‐blind , placebo‐controlled , multicenter trial . Setting : Twenty‐three medical and surgical intensive care units in university centers and large teaching hospitals . Patients : Patients ( n = 653 ) with score‐defined sepsis ( sepsis score 12–27 ) and score‐defined sepsis‐induced severity of disease ( Acute Physiology and Chronic Health Evaluation II score 20–35 ) . Interventions : Patients were assigned to receive either placebo or ivIgG ( day 0 , 0.6 g/kg body weight ; day 1 , 0.3 g/kg body weight ) . Measurements and Main Results : The prospect ively defined primary end point was death from any cause after 28 days . Prospect ively defined secondary end points were 7‐day all‐cause mortality , short‐term change in morbidity , and pulmonary function at day 4 . Six hundred fifty‐three patients from 23 active centers formed the intention‐to‐treat group , 624 patients the per‐ protocol group  ( placebo group , n = 303 ; ivIgG group , n = 321 ) . The 28‐day mortality rate was 37.3 % in the placebo group and 39.3 % in the ivIgG group and thus not significantly different ( p = .6695 ) . Seven‐day mortality was not reduced , and 4‐day pulmonary function was not improved . Drug‐related adverse events were rare in both groups . Exploratory findings revealed a 3‐day shortening of mechanical ventilation in the surviving patients and no effect of ivIgG on plasma levels of interleukin‐6 and tumor necrosis factor receptors I and II . Conclusions : In patients with score‐defined severe sepsis , ivIgG with a total dose of 0.9 g/kg body weight does not reduce mortality Objective : To evaluate the effect of intravenous IgMA-enriched immunoglobulin ( ivIGMA ) therapy on mortality in neutropenic patients with hematologic malignancies and sepsis syndrome or septic shock . Design : Multiple-center , prospect i ve r and omized , controlled study . Setting : Six university hospitals in Germany . Patients : Patients were 211 neutropenic patients with sepsis syndrome or septic shock after chemotherapy for severe hematologic disorders between 1992 and 1999 . Interventions : Patients received 1300 mL of ivIGMA ( 7.8 g IgM , 7.8 g IgA , and 49.4 g IgG ) infused intravenously within a period of 72 hrs or human albumin according to the same schedule as ivIGMA . Measurements and Main Results : All-cause mortality at 28 days , sepsis-related mortality at 28 days , all-cause mortality at 60 days , mortality from septic shock , and mortality from microbiologically proven Gram-negative sepsis and septic shock were recorded . Immunoglobulin had no benefit over human albumin . The 28-day mortality rate was 26.2 % and 28.2 % in the ivIGMA and control patients , respectively ( difference , 2.0 % [ 95 % confidence interval , −10.2 to 14.2 percentage points ] ) . Likewise , the 60-day mortality rate did not differ between both arms ( 29.6 % vs. 34.7 % in the ivIGMA and control patients , respectively ) . Mortality rates in patients with sepsis syndrome ( 17.1 % vs. 16.7 % ) and septic shock ( 51.9 % vs. 54.8 % ) were also found to be similar between both groups . Conclusions : Intravenous ivIGMA had no beneficial effects in neutropenic patients with hematologic malignancies and sepsis syndrome and septic shock Thrombocytopenia frequently complicates systemic infection and results from multiple possible mechanisms . We and others have demonstrated that platelet-associated IgG ( PAIgG ) levels are elevated in the majority of patients with septic thrombocytopenia .  Corticosteroids may be undesirable as a treatment for thrombocytopenia for patients with severe infection because of their potential for suppressing the immune response . We hypothesized that septic thrombocytopenia is , in most cases , an immune disorder analogous to idiopathic thrombocytopenic purpura ( ITP ) which might respond to intravenous gamma-globulin as a treatment for increasing the platelet count in this disorder . Intravenous immune globulin ( IVIG ) , 400 mg/kg daily for 3 days , was administered in a r and omized double-blind placebo-controlled trial . Twenty-nine patients who developed thrombocytopenia during a documented , septic episode were studied . Patients with disseminated intravascular coagulation ( DIC ) , hypersplenism , or drugs known to cause thrombocytopenia were excluded . Elevated PAIgG levels were documented in 52 % of evaluable patients . Mean platelet counts in the IVIG group rose from 43 K at study entry to 178 K ( 411 % rise ) by Day 9 . In the placebo group platelets rose from 51 K to 125 K ( 261 % rise;P = 0.02 ) . Seventy-seven percent of the IVIG group had a minimum peak rise of 35 K , vs 56 % of the placebo group . Three patients in the placebo group had a serious bleeding episode , vs one in the IVIG group . The use of IVIG to treat septic thrombocytopenia not associated with DIC leads to a more rapid , more sustained , and greater increase in platelet count than placebo . Its use is recommended in the septic patient who is bleeding or is likely to need invasive or surgical procedures 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 prospect i ve , r and omized , 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 r and omized . 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 Introduction Severe sepsis is associated with high levels of morbidity and mortality , placing a high burden on healthcare re sources . We aim ed to study outcomes in the five years after severe sepsis . Methods This was a cohort study using data from a  prospect i ve audit in 26 adult ICUs in Scotl and .  Mortality was measured using clinical data bases and quality of life using Short Form 36 ( SF-36 ) at 3.5 and 5 years after severe sepsis . Results A total of 439 patients were recruited with a 58 % mortality at 3.5 years and 61 % mortality at 5 years . A total of 85 and 67 patients responded at 3.5 and 5 years follow-up , respectively . SF-36 physical component score ( PCS ) was low compared to population controls at 3.5 years ( mean 41.8 ( SD 11.8 ) ) and at 5 years ( mean 44.8 ( SD 12.7 ) ) . SF-36 mental component score ( MCS ) was slightly lower than population controls at 3.5 years ( mean 47.7 ( SD 14.6 ) ) and at 5 years after severe sepsis ( mean 48.8 ( SD 12.6 ) ) . The majority of patients were satisfied with their current quality of life ( QOL ) ( 80 % ) and all patients would be willing to be treated in an ICU again if they become critically ill despite many having unpleasant memories ( 19 % ) and recall ( 29 % ) of ICU events . Conclusions Patients with severe sepsis have a high ongoing mortality after severe sepsis . They also have a significantly lower physical QOL compared to population norms but mental QOL scores were only slightly below population norms up to five years after severe sepsis . All survivors would be willing to be treated in an ICU again if critically ill . Mortality and QOL outcomes were broadly similar to other critically ill cohorts throughout the five years of follow-up Whilst significant advances have been made in persuading clinical research ers of the value of conducting economic evaluation alongside clinical trials , a number of problems remain . The most fundamental is the fact that economic principles are almost entirely ignored in the traditional approach to trial design . For example , in the selection of an optimal sample size no consideration is given to the marginal costs or benefits of sample information . In the traditional approach this can lead to either unbounded or arbitrary sample sizes . This paper presents a decision-analytic approach to trial design which takes explicit account of the costs of sampling , the benefits of sample information and the decision rules of cost-effectiveness analysis . It also provides a consistent framework for setting priorities in research funding and establishes a set of screens ( or hurdles ) to evaluate the potential cost-effectiveness of research proposals . The framework permits research priority setting based explicitly on the budget constraint faced by clinical practitioners and on the information available prior to prospect i ve research . It demonstrates the link between the value of clinical research and the budgetary restrictions on service provision , and it provides practical tools to establish the optimal allocation of re sources between areas of clinical research or between service provision and research The therapeutic use of iv immunoglobulins of the G class in association with antibiotics in patients with severe sepsis is reported . As compared to the r and omized control group of patients treated with  antibiotics alone , patient survival was only slightly improved ( from 25 % to 42 % ; NS ) ; however , the defervescence time was significantly shorter ( 10 vs. 16 days ) , and a greater percentage of microbiologically positive cultures became negative ( 40 % vs. 8 % ; p less than .01 ) . The percentage of 
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Results We found a large degree of statistical heterogeneity in the clinical evidence on treatment effect , and the source of such heterogeneity was unclear .
The incremental cost-effectiveness ratio  of IVIG is within the borderline region of estimates considered to represent value for money , but results appear highly sensitive to the choice of model used for clinical effectiveness .
Conclusions Our analyses suggest that there is a need for a further RCT .
Results on the value of conducting such research , however , were sensitive to the clinical effectiveness model used , reflecting the high level of heterogeneity in the evidence base