A clinical trial on the prevention of catheter-related sepsis using a new hub model.

BACKGROUND: Catheter hub contamination is being increasingly recognized as a source of catheter-related sepsis. The authors have investigated the efficacy of a new hub design in preventing endoluminal catheter contamination and catheter-related sepsis arising at the hub. METHODS: Adult surgical and intensive care patients requiring a subclavian catheter for at least 1 week were randomly assigned to receive catheters with standard connectors (control group, n=73) or equipped with a new hub model (new hub group, n=78). Skin, catheter tip, and hub cultures were performed at the time the catheter was withdrawn because therapy was terminated or because of suspicion of sepsis, in which case peripheral blood cultures were taken. RESULTS: Of the 151 patients included, 15 (10%) developed catheter-related sepsis. Catheters were more often withdrawn because suspicion of infection in the control group (42 vs. 19%, p<0.005). Catheter sepsis rate was higher in the control group (16 vs. 4%, p<0.01) because of the low rate of catheter sepsis arising at the hub observed in the new hub group (1 vs. 11%, p<0.01). The prevalence of culture-positive catheter hubs without associated bacteremia (colonization) was higher in the control group (18 vs. 5%, P<0.03). CONCLUSIONS: A new catheter hub has proved to be useful in preventing endoluminal bacterial colonization and catheter-related sepsis in subclavian lines inserted for a mean of 2 weeks.     

A bedside scoring system ("Candida score") for early antifungal treatment in nonneutropenic critically ill patients with Candida colonization

OBJECTIVE: To obtain a score for deciding early antifungal treatment when candidal infection is suspected in nonneutropenic critically ill patients. DESIGN: Analysis of data collected from the database of the EPCAN project, an ongoing prospective, cohort, observational, multicenter surveillance study of fungal infection and colonization in intensive care unit (ICU) patients. SETTING: Seventy-three medical-surgical ICUs of 70 teaching hospitals in Spain. PATIENTS: A total of 1,699 ICU patients aged 18 yrs and older admitted for at least 7 days between May 1998 and January 1999 were studied. INTERVENTIONS: Surveillance cultures of urine, tracheal, and gastric samples were obtained weekly. Patients were grouped as follows: neither colonized nor infected (n=719), unifocal or multifocal Candida colonization (n=883), and proven candidal infection (n=97). The odds ratio (OR) for each risk factor associated with colonization vs. proven candidal infection was estimated. A logistic regression model was performed to adjust for possible confounders. The "Candida score" was obtained according to the logit method. The discriminatory power was evaluated by the area under the receiver operating characteristics curve. MEASUREMENTS AND MAIN RESULTS: In the logit model, surgery (OR=2.71, 95% confidence interval [CI], 1.45-5.06); multifocal colonization (OR=3.04, 95% CI, 1.45-6.39); total parenteral nutrition (OR=2.48, 95% CI, 1.16-5.31); and severe sepsis (OR=7.68, 95% CI, 4.14-14.22) were predictors of proven candidal infection. The "Candida score" for a cut-off value of 2.5 (sensitivity 81%, specificity 74%) was as follows: parenteral nutrition, +0.908; surgery, +0.997; multifocal colonization, +1.112; and severe sepsis, +2.038. Central venous catheters were not a significant risk factor for proven candidal infection (p=.292). CONCLUSIONS: In a large cohort of nonneutropenic critically ill patients in whom Candida colonization was prospectively assessed, a "Candida score">2.5 accurately selected patients who would benefit from early antifungal treatment.     

Cost-effectiveness analysis of the treatment of ventilator-associated pneumonia with linezolid or vancomycin in Spain

The aim of this study was to assess the cost-effectiveness of linezolid (LIN) versus vancomycin (VAN) for the treatment of ventilator-associated pneumonia (VAP) using a decision model analysis from the National Health System perspective. Patients and participants comprising four subgroups were analyzed: all, Gram-positive (GP), Staphylococcus aureus (SA), methicillin-resistant SA (MRSA). The treatments were LIN 600 mg i.v., every 12 hours, 10 days and VAN 1,000 mg i.v., every 12 hours 10 days. The primary outcome was the incremental cost-effectiveness of LIN in terms of cost per added quality-adjusted life year (QALY) gained. The secondary outcome was the marginal cost per year of life saved (LYS) generated by using LIN. Clinical cure and survival rates estimates were derived from a retrospective analysis of two trials comparing LIN with VAN. QALY was based on time-trade off study. Resource use and unit costs (Euros 2003) were obtained from Spanish VAP treatment and health cost databases. The additional QALY and LYS per LIN patients were 0.392; 0.688; 0.606; 1.805 and 0.471; 0.829; 0.729; 2.175 respectively, compared with those of VAN in the patients with VAP (all, GP, SA, and MRSA, respectively). The additional costs for LYS with LIN, as compared to VAN were 1,501.31; 827.63; 955.13 and 289.51 Euros, respectively. The additional cost per QALY with LIN was 1,803.87; 997.25; 1,149.00 and 348.85 Euros, respectively. CONCLUSIONS: LIN was more cost-effective than VAN in the treatment of VAP in Spain, with an additional cost per QALY/LYS gained below the acceptable threshold in Spain of Euros 30,000 for new therapies.     

Clinical use and tolerability of voriconazole in the treatment of fungal infections in critically ill patients

The clinical use and tolerability of voriconazole in daily practice for the treatment of fungal infection in critically ill patients was assessed in an open-label, non-comparative, observational study. All patients admitted to medical-surgical Intensive Care Units (ICUs) of 21 hospitals in Spain between February 2003 and January 2004, who were treated with voriconazole because of known or suspected fungal infection, were included. A total of 130 patients received voriconazole (6.2 cases per ICU). Fungal infections were classified as proven in 50 patients (38.5%) and probable in 38 (29.2%). The etiology was established in 103 patients, with Candida albicans and Aspergillus fumigatus as the most common pathogens. In 98 (75.4%) patients, voriconazole was initially administered intravenously. Fifty-three patients (40.8%) were treated with other antifungal agents prior to the use of voriconazole. In 21 patients (16.2%), voriconazole was administered in combination with other antifungal drugs. Clinical responses were cure and improvement in 65 (50%) patients, failure in 26 (20%), and undetermined in 39 (30%). The crude ICU mortality was 49.2%. According to multivariate analysis, ICU mortality was significantly associated with pneumonia (OR = 3.30, 95% CI 1.07-10.18) and infection caused by Aspergillus spp. (OR = 3.70, 95% Cl 1.12-12.28), whereas eradication of the causative microorganisms was inversely associated (OR = 0.13, 95% CI 0.05-0.34). Adverse events were recorded in 65 patients, probably or possibly related to the study drug in 21. In conclusion, in critically ill patients admitted to the ICU, the use of voriconazole was affective in 50% of cases. The drug was well tolerated and discontinuation of voriconazole treatment due to adverse events was not necessary.     

Candiduria in critically ill patients admitted to intensive care medical units

BACKGROUND: The purpose of this study was to determine the incidence of candiduria in critically ill patients admitted to intensive care medical units (ICUs), to identify risk factors for candiduria and to assess the frequency distribution of different Candidaspp. SUBJECTS AND METHODS: This was a prospective cohort observational and multicenter study. A total of 1,765 patients older than 18 years of age who were admitted for at least 7 days to 73 medical-surgical ICUs of 70 Spanish hospitals were included in the study. Urine cultures were performed once a week. RESULTS. In 389 patients (22%), Candidaspp. in one or more urine samples were isolated. In the multivariate analysis, independent risk factors for candiduria included: age >65 years, female sex, length of hospital stay before ICU admission, diabetes mellitus, total parenteral nutrition, mechanical ventilation and previous use of antimicrobials. Candida albicanswas recovered in 266 cases (68.4%), followed by C. glabrata(32 cases, 8.2%) and C. tropicalis(14 cases, 36%). Previous use of antifungal agents was the only risk factor for the selection of Candidanon-albicans candiduria (OR 2.64, 95% CI 1.35-5.14, P=0.004). In-hospital mortality was 48.8% in patients with candiduria compared to 36.6% in those without candiduria ( P<0.001). Significant differences were also found for ICU mortality (38.% vs. 28.1%, P<0.001). CONCLUSIONS: Twenty-two percent of critically ill patients admitted for more than 7 days in the ICU developed candiduria. C. albicanswas the most frequent causative pathogen. Previous use of antifungals was the only risk factor for the selection of Candidanon-albicans.     

Early antibiotic treatment (prophylaxis) of septic complications in severe acute necrotizing pancreatitis: a prospective, randomized, multicenter study comparing two regimens with imipenem-cilastatin

Objective We compared two imipenem regimens for prevention of septic complications in patients with severe acute necrotizing pancreatitis (ANP).Design and setting Prospective, randomized open clinical trial involving intensive care units of 14 Spanish Hospitals.Participants 92 patients with ANP.Interventions Imipenem/cilastatin was administered at 500 mg four times daily starting at the time of diagnosis of ANP, within the first 96 h from the onset of symptoms. Patients were randomized to receive antibiotic prophylaxis either for 14 days (group 1) or at least for 14 days and as long as major systemic complications of the disease persisted (group 2).Results Antibiotic was maintained in group 2 for 19.7±10.9 days. The incidence of infected pancreatic necrosis, pancreatic abscess, and extrapancreatic infections was 11%, 17%, and 28% in group 1 and 17.4%, 13%, and 35% in group 2 (n.s.). Pancreatic or extrapancreatic infection by Candida albicans occurred in 7% and 22% of patients. Global mortality was 18.5% (10.9% secondary to septic complications), without differences between groups. In patients with persisting systemic complications at day 14 mortality was almost always secondary to septic complications and decreased from 25% (group 1) to 8.8% (group 2) by maintaining antibiotic prophylaxis.Conclusions Compared to a 14-day imipenem prophylaxis, a longer antibiotic administration in patients with ANP is not associated with a reduction in the incidence of septic complications of the disease. However, prolonged imipenem administration in patients with persisting systemic complications tends to reduce mortality in ANP compared to a 14-days regimen.Electronic Supplementary Material Supplementary material is available in the online version of this article at http://dx.doi.org/10.1007/s00134-003-1956-z     

Modification of empiric antibiotic treatment in patients with pneumonia acquired in the intensive care unit

Objective To assess the frequency of and the reasons for changing empiric antibiotics during the treatment of pnnumonia acquired in the intensive care unit (ICU).Design A prospective multicenter study of 1 year's duration.Setting Medical and surgical ICUs in 30 hospitals all over Spain.Patients Of a total of 16872 patients initially enrolled into the study, 530 patients developed 565 episodes of pneumonia after admission to the ICU.Results Empiric antibiotics were administered in 490 (86.7%) of the 565 episodes of pneumonia. The antimicrobials most frequently used were amikacin in 120 case, tobramycin in 110, ceftazidime in 96, and cefotaxime in 96. Monotherapy was indicated in 135 (27.6%) of the 490 episodes, a combination of two antibiotics in 306 episodes (62.4%), and a combination of three antibiotics in 49 episodes (10%). The empiric antibiotic treatment was modified in 214 (43.7%) cases because of isolation of a microorganism not covered by treatment in 133 (62.1%) cases, lack of clinical response in 77 (36%), and development of resistance in 14 (6.6%). Individual factors associated with modification of empiric treatment identified in the multivariate analysis were microorganism not covered (relative risk (RR)) 22.02; 95% confidence interval (CI) 11.54 to 42.60;p<0.0001), administration of more than one antimicrobial (RR 1.29; 95% CI 1.02 to 1.65;p=0.0018) attributable mortability was 16.2%.Supported by a grant from Bristol-Myers-Squibb. The results of this study were presented in part at the 4th Panamerican and Iberic Congress on Intensive Care, Rio de Janeiro, Brazil, 1991     

Management of antimicrobial use in the intensive care unit

Indications for the use of antimicrobials in critically ill patients are similar to those for other hospitalised patients. However, the selection of agents depends on the particular characteristics of patients in the intensive care unit (ICU), the form of presentation of infection, the type of infection and the bacteriological features of the causative pathogens. The use of antimicrobials in patients admitted to medical-surgical ICUs varies between 33 and 53%. The selection of empirical antimicrobials to be included in treatment protocols of the most common infections depends on the strong interrelationship between patient characteristics, predominant pathogens in each focus. and antimicrobials used for treatment. Epidemiological studies carried out in the past have identified the microorganisms most frequently responsible for community-acquired and nosocomial infections in patients admitted to ICUs. Susceptibility to antimicrobial agents may be different between each geographical area, between each hospital and even within the same hospital service. In addition, susceptibility patterns may change temporarily in relation to the use of particular antimicrobials or in association with other unknown factors so that assessment of endemic antimicrobial resistance patterns is very useful in order to tailor the antimicrobial regimens of therapeutic protocols. Antimicrobial use should not be a routine procedure. The clinical course of the patient (an indicator of effectiveness) should be closely monitored as well as the possible appearance of adverse effects and/or multiresistant pathogens. Controls are based on the assessment of plasma drug concentrations and microbiological surveillance to detect the presence of multiresistant strains or new antibacterial-resistant pathogens. Prevention of the development of multiresistant pathogens is the main goal of the ICU antimicrobial policy. Although a series of general strategies to reduce the presence of multiresistant pathogens have been proposed, the implementation of these recommendations in ICUs requires the cooperation of a member of the intensive care team.