WNEU/Holyoke Medical Center Clinical Pharmacy Rotation Journal Club Presentation Robert Ferrante Chlorhexidine Bathing and Health Care–Associated Infections A Randomized Clinical Trial 1. INTRODUCTION a. What is the generally accepted current practice in this area? i. CDC calculated HAI prevalence in 2007 and adjusted patient costs of HAI by site of infection. Of importance would be the over 1.7 million HAIs as well as the range of cost per infection ranging from $800 for a CAUTI to $25,000 for a CLABSI.1 ii. CDC considers daily skin cleaning Class II recommendation 2011 Prevention of intravascular Catheter related infection 2 iii. 2009 Climo et. al. did a similar study that found significant decrease in MRSA vanco resistant enterococci, CLABSIs, and healthcare related infections 7700 patients 3 b. What question does this paper try to answer? i. The intent was to replicate previous findings by Climo et al to reduce future HAI’s ii. Official objective to determine if daily bathing with CHG wipes decreases HAI in critically ill patients c. Is this a question that you think is worth answering? i. In the event that this study confirms previous findings, then there is great potential to positively affect patient care, improve healthcare spending, and reduce HAI in the hospital ii. Also increase in cost + unneccesary exposure may result in resistant organisms. d. Who funded the study? i. The study was funded through grants from the NIH and Vanderbilt Institue for Clinical and Translational Research. Chlorhexidine and nonantimicrobial clothes were purchased from Sage Products 2. METHODS a. What is the study design? i. The study in a pragmatic cluster randomized, crossover study of 9340 patients admitted to 5 adult ICU units of a tertiary medical center in Nashville, Tennessee, from July 2012 – July 2013 b. What is the study population? i. All patients admitted to cardiovascular, medical, neurological, surgical, and trauma ICUs during the study period c. Is this similar to ours (external validity)? i. The patient population of Vanderbilt Medical Center is comparable to national levels d. What were the inclusion/exclusion criteria? i. Inclusion 1. All patients admitted to cardiovascular, medical, neurological, surgical, and trauma ICUs during the study period ii. Exclusion 1. Allergy to chlorhexidine 2. Admitted with burns, toxic epidermal necrolysis, or SJS 3. Treating physician thought bathing would be unsafe 4. Patients admitted to the hospital during the washout period e. What is the intervention? i. . The 5 ICUs were individually randomly assigned to either start using chlorhexidine wipes or non-antimicrobial wipes for a 10 week study period and then undergo a 2 week washout period before switching to the other arms of the study. This process would be repeated a second time for a total of 4 study periods f. Is the control comparison considered current standard of care? i. Both practices Are common g. When was the study conducted? i. Over the course of a year July 2012-2013 h. What outcome measurements do the authors use? i. Primary: Composite of central line-associated bloodstream infections (CLABSIs), Catherter-associated urinary tract infections (CAUTIs), ventilator-associated pneumonia (VAP), and C. diff infections. ii. Secondary: included rates of clinical cultures that tested positive for multidrug-resistant organisms, blood culture contamination, health care associated blood stream infections, and rates of primary outcome by ICU i. Could you replicate the study with the information given? i. Yes 3. BIAS a. Is there evidence of selection bias? i. No b. Is there bias in classifications of disease or measurements? i. No, infection control personnel responsible for diagnosing infections were blinded c. Are there any other forms of bias present? i. Smell of wipes makesit obvious which treatment patient is getting. Patient and nurse both know 4. RESULTS a. Are the outcomes clinically relevant? i. Yes, the results are clinically relevant because they do not recommend washing critically ill patients with chlorhexidine. b. What are the results and how are they presented? i. Intention to treat and as treated analysis ii. Primary outcome: 55 CHF infections, 60 NABX 1. Intention to treat 2. 2.86/1000 pt days vs 2.90 pt days 95% (CI -1.10-1.01) P = .95 3. As treated 4. 2.84 vs 2.98 pt days 95% (CI -0.92 to 1.20) P = .79 iii. Secondary outcomes: After adjusting for baseline variables, no difference was detected in any of the secondary outcomes 1. Interesting In-hospital mortality 449 vs 367 9.25% vs 8.18 p = 0.07 2. P-value difference in intention to treat vs in as treated a. Table 2 b. Length of stay 0.12 vs 0.004 c. In hospital mortality 0.07 vs 0.046 d. Table 3 e. CV Unit blood culture contamination P = 0.003 c. Can you identify other results that you might want to see that are not presented? i. Adjusted for baseline d. To what extent does the study establish a causal relationship between two variables (internal validity)? i. Strong, but could be stronger, would like more information e. Was a power analysis performed? i. The study was conducted over 1 year. The approximately 10 000 patients expected to be admitted to the participating ICUs based on the previous year’s admissions would provide at least 95%power to detect a change in the primary outcome of 0.1 infections per 1000 patient-days 5. DISCUSSION a. Are limitations addressed? i. Included patients under primary arm if went through two study arms ii. Active surveillance for MDR colonization was not done iii. Effectiveness study vs efficacy study; therefore, not done by study personnel iv. 10 weeks versus 24 weeks b. Have confounding variables been discussed? i. Adjusted analysis was performed for confounding variables such as differences in comorbidities and expected mortality differences 6. CONCLUSION a. Do the results of the study support the conclusion? i. Yes, no statistical or clinical significance can be found in b. Will this change your clinical practice? i. It has changed my perspective on daily washing protocols c. If you were going to do research in this area, what would be your next study? i. Similar study but over a longer period 1.) Scott R. The Direct Medical Costs of Healthcare –Associated Infections in U.S. Hospitals and the Benefits of Prevention. Division of Healthcare Quality Promotion National Center for Preparedness, Detection, and Control of Infectious Disease Coordinating Center for Infectious Disease Centers for Disease Control and Prevention. [Internet]. Sited 2015 Feb 25. Available from: http://www.cdc.gov/HAI/pdfs/hai/Scott_CostPaper.pdf 2.) O’Grady N, Alexander M, Burns L, et al. Guidelines for the Prevention of Intravascular Catheter-Rerlated Infections (2011.) Am J Infect Control 2011:39(4), S1-S34 3.) Calfee DP, Salgado CD,Milstone AM, et al. Strategies to prevent methicillin-resistant Staphylococcus aureus transmission and infection in acute care hospitals: 2014 update. Infect Control Hosp Epidemiol. 2014;35(7):772-796.