科研之友
微信
新浪微博
Facebook
分享链接
摘要
Background: Management of cardiac intensive care unit (ICU) sepsis is complicated by the high incidence of systemic inflammatory response syndrome, which mimics sepsis but without an infective cause. This pilot randomised trial investigated whether or not, in the ICU, 48 hours of broad-spectrum antibiotic treatment was adequate to safely treat suspected sepsis of unknown and unproven origin and also the predictive power of newer biomarkers of sepsis. %26lt;br%26gt;Objective: The main objective of this pilot study was to provide preliminary data on the likely safety and efficacy of a reduced course of antibiotics for the treatment of ICU infections of unknown origin. %26lt;br%26gt;Design: A pilot, single-centre, open-label randomised trial. %26lt;br%26gt;Setting: This study was carried out in the ICU of a tertiary heart and chest hospital. %26lt;br%26gt;Participants: Patients being treated within the ICU were recruited into the trial if the intensivist was planning to commence antibiotics because of evidence of systemic inflammatory response syndrome and a strong suspicion of infection but there was no actual known source for that infection. %26lt;br%26gt;Interventions: Broad-spectrum antibiotic treatment administered for 48 hours (experimental) compared with treatment for 7 days (control). %26lt;br%26gt;Main outcome measures: The primary outcome was a composite outcome of the rate of death or initiation of antibiotic therapy after the completion of the treatment schedule allocated at randomisation. Secondary outcomes included the duration of mechanical ventilation and ICU and hospital stay; the incidence of infection with Clostridium difficile (B. S. Weeks %26 E. Alcamo) Jones %26 Bartlett International Publishers, 2008, or methicillin-resistant Staphylococcus aureus (MRSA) (B. S. Weeks %26 E. Alcamo) Jones %26 Bartlett International Publishers, 2008; resource utilisation and costs associated with each of the two pilot arms; the ratio of patients screened to patients eligible to patients randomised; the incidence of crossover between groups; and the significance of newer biomarkers for sepsis for predicting patients%26apos; need for further antibiotics. %26lt;br%26gt;Results: A total of 46 patients were recruited into the trial, with 23 randomised to each group. There was no significant difference between the two groups in terms of the composite primary outcome measure. The risk difference was 0.12 [95% confidence interval (Cl) 0.11 to 0.13; p=0.3]. In the 2-day group, four patients (17.4%) required further antibiotics compared with three (13%) in the 7-day group. Four patients died within the trial period and the deaths were not trial related. Patients who died during the trial period received no additional antibiotics in excess of their trial allocation. There were no documented incidences of MRSA or C. difficile infection in either group. No significant differences in adverse events were observed between the groups. Key economic findings were mean antibiotic costs per patient of 168.97 pound for the 2-day group and 375.86 pound for the 7-day group. The potential per annum cost saving for the ICU of 2-day treatment was estimated to range from 108,140 pound to 126,060 pound. Patient screening was considered the biggest barrier to recruitment. There was no crossover between the two randomised groups. Data verification ascertained %26gt;98% accuracy in data collection. Baseline procalcitonin was found to be predictive of the composite outcome (death and needing further antibiotics) (odds ratio 1.79, 95% CI 1.20 to 2.67; p=0.005). Analysis of baseline procalcitonin also indicated a trend towards it being a predictor of restarting antibiotics, with an odds ratio of 1.45 (95% CI 1.04 to 2.02; p=0.01). %26lt;br%26gt;Conclusions: Data from this pilot study suggest that there could be significant benefits of reducing broad-spectrum antibiotic use in the ICU without it undermining patient safety, with a potential cost saving in our unit of over 100,000 pound per year. Evidence from this pilot trial is not definitive but warrants further investigation using a large randomised controlled trial.
- 出版日期2012-9
