Increasing inspired oxygen to decrease surgical site infection: time to shift the quality improvement research paradigm.
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Administration, Inhalation↗
Biomedical subjects
E Patchen Dellinger
Publications and source records attributed to E Patchen Dellinger.
Early mortality among Medicare beneficiaries undergoing bariatric surgical procedures.
CONTEXT: Case series demonstrate that bariatric surgery can be performed with a low rate of perioperative mortality (0.5%), but the rate among high-risk patients and the community at large is unknown. OBJECTIVES: To evaluate the risk of early mortality among Medicare beneficiaries and to determine the relative risk of death among older patients. DESIGN: Retrospective cohort study. SETTING AND PATIENTS: All fee-for-service Medicare beneficiaries, 1997-2002. MAIN OUTCOME MEASURES: Thirty-day, 90-day, and 1-year postsurgical all-cause mortality among patients undergoing bariatric procedures. RESULTS: A total of 16 155 patients underwent bariatric procedures (mean age, 47.7 years [SD, 11.3 years]; 75.8% women). The rates of 30-day, 90-day, and 1-year mortality were 2.0%, 2.8%, and 4.6%, respectively. Men had higher rates of early death than women (3.7% vs 1.5%, 4.8% vs 2.1%, and 7.5% vs 3.7% at 30 days, 90 days, and 1 year, respectively; P<.001). Mortality rates were greater for those aged 65 years or older compared with younger patients (4.8% vs 1.7% at 30 days, 6.9% vs 2.3% at 90 days, and 11.1% vs 3.9% at 1 year; P<.001). After adjustment for sex and comorbidity index, the odds of death within 90 days were 5-fold greater for older Medicare beneficiaries (aged > or =75 years; n = 136) than for those aged 65 to 74 years (n = 1381; odds ratio, 5.0; 95% confidence interval, 3.1-8.0). The odds of death at 90 days were 1.6 times higher (95% confidence interval, 1.3-2.0) for patients of surgeons with less than the median surgical volume of bariatric procedures (among Medicare beneficiaries during the study period) after adjusting for age, sex, and comorbidity index. CONCLUSIONS: Among Medicare beneficiaries, the risk of early death after bariatric surgery is considerably higher than previously suggested and associated with advancing age, male sex, and lower surgeon volume of bariatric procedures. Patients aged 65 years or older had a substantially higher risk of death within the early postoperative period than younger patients.
Adult↗
Effect of a second-generation venous catheter impregnated with chlorhexidine and silver sulfadiazine on central catheter-related infections: a randomized, controlled trial.
BACKGROUND: Central venous catheter-related infections are a significant medical problem. Improved preventive measures are needed. OBJECTIVE: To ascertain 1) effectiveness of a second-generation antiseptic-coated catheter in the prevention of microbial colonization and infection; 2) safety and tolerability of this device; 3) microbiology of infected catheters; and 4) propensity for the development of antiseptic resistance. DESIGN: Multicenter, randomized, double-blind, controlled trial. SETTING: 9 university-affiliated medical centers. PATIENTS: 780 patients in intensive care units who required central venous catheterization. INTERVENTION: Patients received either a standard catheter or a catheter coated with chlorhexidine and silver sulfadiazine. MEASUREMENTS: The authors assessed catheter colonization and catheter-related infection, characterized microbes by molecular typing, and determined their susceptibility to antiseptics. Patient tolerance of the catheter was monitored. RESULTS: Patients with the 2 types of catheters had similar demographic features, clinical interventions, laboratory values, and risk factors for infection. Antiseptic catheters were less likely to be colonized at the time of removal compared with control catheters (13.3 vs. 24.1 colonized catheters per 1000 catheter-days; P < 0.01). The center-stratified Cox regression hazard ratio for colonization controlling for sampling design and potentially confounding variables was 0.45 (95% CI, 0.25 to 0.78). The rate of definitive catheter-related bloodstream infection was 1.24 per 1000 catheter-days (CI, 0.26 to 3.62 per 1000 catheter-days) for the control group versus 0.42 per 1000 catheter-days (CI, 0.01 to 2.34 per 1000 catheter-days) for the antiseptic catheter group (P = 0.6). Coagulase-negative staphylococci and other gram-positive organisms were the most frequent microbes to colonize catheters. Noninfectious adverse events were similar in both groups. Antiseptic susceptibility was similar for microbes recovered from either group. LIMITATIONS: The antiseptic catheter was not compared with an antibiotic-coated catheter, and no conclusion can be made regarding its effect on bloodstream infection. CONCLUSIONS: The second-generation chlorhexidine-silver sulfadiazine catheter is well tolerated. Antiseptic coating appears to reduce microbial colonization of the catheter compared with an uncoated catheter.
Aged↗
Should we measure body temperature for patients who have recently undergone surgery?
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Bacterial Infections↗
Use of antimicrobial prophylaxis for major surgery: baseline results from the National Surgical Infection Prevention Project.
HYPOTHESIS: Surgical site infections (SSIs) are a major contributor to patient injury, mortality, and health care costs. Despite evidence of effectiveness of antimicrobials to prevent SSIs, previous studies have demonstrated inappropriate timing, selection, and excess duration of administration of antimicrobial prophylaxis. We herein describe the use of antimicrobial prophylaxis for Medicare patients undergoing major surgery. DESIGN: National retrospective cohort study with medical record review. SETTING: Two thousand nine hundred sixty-five acute-care US hospitals. PATIENTS: A systematic random sample of 34,133 Medicare inpatients undergoing coronary artery bypass grafting; other open-chest cardiac surgery (excluding transplantation); vascular surgery, including aneurysm repair, thromboendarterectomy, and vein bypass operations; general abdominal colorectal surgery; hip and knee total joint arthroplasty (excluding revision surgery); and abdominal and vaginal hysterectomy from January 1 through November 30, 2001. MAIN OUTCOME MEASURES: The proportion of patients who had parenteral antimicrobial prophylaxis initiated within 1 hour before the surgical incision; the proportion of patients who were given a prophylactic antimicrobial agent that was consistent with currently published guidelines; and the proportion of patients whose antimicrobial prophylaxis was discontinued within 24 hours after surgery. RESULTS: An antimicrobial dose was administered to 55.7% (95% confidence interval [CI], 54.8%-56.6%) of patients within 1 hour before incision. Antimicrobial agents consistent with published guidelines were administered to 92.6% (95% CI, 92.3%-92.8%) of the patients. Antimicrobial prophylaxis was discontinued within 24 hours of surgery end time for only 40.7% (95% CI, 40.2%-41.2%) of patients. CONCLUSION: Substantial opportunities exist to improve the use of prophylactic antimicrobials for patients undergoing major surgery.
Aged↗
Hospitals collaborate to decrease surgical site infections.
BACKGROUND: Despite a large body of evidence describing care processes known to reduce the incidence of surgical site infections, many are underutilized in practice. METHODS: Fifty-six hospitals volunteered to redesign their systems as part of the National Surgical Infection Prevention Collaborative, a 1-year demonstration project sponsored by the Centers for Medicare & Medicaid Services. Each facility selected quality improvement objectives for a select group of surgical procedures and reported monthly clinical process measure data. RESULTS: Forty-four hospitals reported data on 35,543 surgical cases. Hospitals improved in measures related to appropriate antimicrobial agent selection, timing, and duration; normothermia; oxygenation; euglycemia; and appropriate hair removal. The infection rate decreased 27%, from 2.3% to 1.7% in the first versus last 3 months. CONCLUSIONS: The Collaborative demonstrated improvement in processes known to be associated with reduced risk of surgical site infections. Quality improvement organizations can be effective resources for quality improvement in the surgical arena.
Cooperative Behavior↗
Current treatment of intraabdominal infections.
Although peritonitis has been recognized as a common and complex disease entity since ancient times, the true understanding and pathophysiology, as well as treatment of peritonitis, continue to plague surgeons and physicians. The clinical course and outcome of peritonitis is dependent upon the struggle between the quantity and virulence of the pathogen and host's physiologic reserve, including the ensuing inflammatory response. The current multimodality treatment of intraabdominal infections is based upon the fundamental principles established by Polk in 1979: surgical source control, fluid resuscitation, adequate nutrition, support of failing organ systems, and antibiotics. Although dramatic advances have been made in the pharmacological treatment of intraabdominal infections, mortality for complicated cases remains high. Consequently, future directions in management of peritonitis may require agents that target specific endotoxin receptors, inflammatory signaling molecules, or immunomodulatory moieties.
Anti-Bacterial Agents↗
The importance of bactericidal drugs: future directions in infectious disease.
BACKGROUND: Although a considerable amount of research has gone into the study of the role of bactericidal versus bacteriostatic antimicrobial agents in the treatment of different infectious diseases, there is no accepted standard of practice. METHODS: A panel of infectious diseases specialists reviewed the available literature to try to define specific recommendations for clinical practice. RESULTS: In infections of the central nervous system, the rapidity with which the organism is killed may be an important determinant, because of the serious damage that may occur during these clinical situations. The failure of bacteriostatic antibiotics to adequately treat endocarditis is well documented, both in human studies and in animal models. CONCLUSION: The bulk of the evidence supports the concept that, in treating endocarditis and meningitis, it is important to use antibacterial agents with in vitro bactericidal activity. This conclusion is based on both human and animal data. The data to support bactericidal drugs' superiority to bacteriostatic drugs do not exist for most other clinical situations, and animal models do not support this concept in some situations. Clinicians should be aware that drugs that are bacteriostatic for one organism may in fact be bactericidal for another organism or another strain of the same organism.
Animals↗
Infectious and immunologic consequences of blood transfusion.
Blood transfusions remain common practice in the critical care and surgical settings. Transfusions carry significant risks, including risks for transmission of infectious agents and immune suppression. Transmission of bacterial infections, although rare, is the most common adverse event with transfusion. The risk for transmission of viral infections has decreased over time, clearly because tests are becoming more sensitive in detecting certain viral infections such as hepatitis B, hepatitis C, and HIV. Several immunomodulatory effects are thought to be related to transfusions, and these can result in cancer recurrence, mortality, and postoperative infections. Numerous studies have been performed to examine the role of leukoreduction in decreasing these transfusion-related complications but results remain contradictory. We review the infectious risks associated with blood transfusion and the most recent data on its immunologic effects, specifically on cancer recurrence, mortality, and postoperative infections in surgical patients. We also review the use of leukoreduction in blood transfusion and its role in preventing transfusion-transmitted infections and immunomodulatory complications.
Blood Transfusion↗
A consensus statement on empiric therapy for suspected gram-positive infections in surgical patients.
BACKGROUND: Multidrug resistance among gram-positive pathogens in tertiary and other care centers is common. A systematic decision pathway to help select empiric antibiotic therapy for suspected gram-positive postsurgical infections is presented. DATA SOURCES: A Medline search with regard to empiric antibiotic therapy was performed and assessed by the 15-member expert panel. Two separate panel meetings were convened and followed by a writing, editorial, and review process. CONCLUSIONS: The main goal of empiric treatment in postsurgical patients with suspected gram-positive infections is to improve clinical status. Empiric therapy should be initiated at the earliest sign of infection in all critically ill patients. The choice of therapy should flow from beta-lactams to vancomycin to parenteral linezolid or quinupristin-dalfopristin. In patients likely to be discharged, oral linezolid is an option. Antibiotic resistance is an important issue, and in developing treatment algorithms for reduction of resistance, the utility of these new antibiotics may be extended and reduce morbidity and mortality.
Anti-Bacterial Agents↗
Impact of gastric bypass operation on survival: a population-based analysis.
BACKGROUND: Bariatric procedures are increasingly performed but their impact on survival is unknown. STUDY DESIGN: We evaluated short- and longterm mortality rates of patients undergoing gastric bypass on a population level compared with a nonoperated cohort of patients with morbid obesity in a retrospective study, using the Washington State Comprehensive Hospital Abstract Reporting System database and the Vital Statistics database. The study included all patients (age 18 to 65 years) from 1987 to 2001 who underwent gastric bypass with ICD-9 diagnostic codes for obesity. The comparator group included patients of similar age with a diagnosis of obesity or morbid obesity who did not have a bariatric procedure. Survival analysis was used to determine the association of surgeon experience on 30-day mortality and of the procedure on survival while controlling for age, gender, and comorbidity index. RESULTS: Of the 66,109 obese patients we evaluated, 3,328 had a bariatric procedure. Incidence of the procedure increased from 0.7 to 10.6 per 100,000 from 1987 to 2001, with a 2.5-fold increase in incidence rate of the procedure in the years after 1996 (incidence rate ratio, 2.5; 95% CI, 2.4 to 2.7). Thirty-day mortality was 1.9% and was associated with surgical inexperience. Within the surgeon's first 19 procedures the odds of death within 30 days were 4.7 times higher (95% CI, 1.2 to 18.2) than at later points in a surgeon's case order. At 15 years followup, 16.3% of nonoperated patients had died as compared with 11.8% of patients who had the bariatric procedure. When survival was compared beginning 1 year after the procedure, the adjusted hazard for death was 33% lower than that of nonoperated patients (hazard ratio 0.67; 95% CI, 0.54 to 0.85). CONCLUSIONS: Thirty-day mortality after gastric bypass is higher than previously reported and closely linked to surgeon inexperience. A modest overall survival benefit was associated with the procedure but a marked survival advantage was noted for patients who survive to the first postoperative year.
Adult↗
The cost-effectiveness of cefepime plus metronidazole versus imipenem/cilastatin in the treatment of complicated intra-abdominal infection.
BACKGROUND: Our objective was to compare the economic benefits of cefepime plus metronidazole with those of imipenem/cilastatin in the treatment of complicated intra-abdominal infections. METHODS: We used a retrospective analysis of clinical outcomes and health resource utilization data collected during a randomized, double-blind, multi-center clinical trial. Seventeen university-affiliated hospitals in the United States and Canada participated, as did 323 patients with complicated intra-abdominal infections. Decision analysis was conducted using a decision node of cefepime vs. imipenem, and chance nodes that included an Acute Physiology and Chronic Health Evaluation (APACHE) II score of #15 versus .15; a need for posttreatment surgical procedures; and clinical outcomes. Effectiveness of treatment was measured by differences in the length and cost of hospital stays, the number and cost of surgical procedures after treatment, cure rates, and the cost of antibiotics. Also evalulated were the incremental costs of cure (i.e., the costs of additional cures). RESULTS: Comparing cefepime plus metronidazole with imipenem/cilastatin, the expected cost of patient care was $8,218 versus $10,414, respectively, and the cost-effectiveness ratio per cure was $10,058 versus $13,685. For severely ill patients (APACHE II score .15), the expected cost was $12,962 versus $23,153, and the cost-effectiveness ratio per cure was $15,321 versus $64,313. CONCLUSIONS: Cefepime plus metronidazole was more cost-effective than imipenem/cilastatin in the treatment of complicated intra-abdominal infections, primarily because of fewer post-treatment surgical procedures and shorter hospital stays. The primary advantage accrued to severely ill patients who had an APACHE II score .15.
APACHE↗
Source control in the management of severe sepsis and septic shock: an evidence-based review.
OBJECTIVE: In 2003, critical care and infectious disease experts representing 11 international organizations developed management guidelines for source control in the management of severe sepsis and septic shock that would be of practical use for the bedside clinician, under the auspices of the Surviving Sepsis Campaign, an international effort to increase awareness and to improve outcome in severe sepsis. DESIGN: The process included a modified Delphi method, a consensus conference, several subsequent smaller meetings of subgroups and key individuals, teleconferences, and electronic-based discussion among subgroups and among the entire committee. METHODS: The modified Delphi methodology used for grading recommendations built on a 2001 publication sponsored by the International Sepsis Forum. We undertook a systematic review of the literature graded along five levels to create recommendation grades from A to E, with A being the highest grade. Pediatric considerations to contrast adult and pediatric management are in the article by Parker et al. on p. S591. CONCLUSION: Source control represents a key component of success in therapy of sepsis. It includes drainage of infected fluids, debridement of infected soft tissues, removal of infected devices or foreign bodies, and finally, definite measures to correct anatomic derangement resulting in ongoing microbial contamination and to restore optimal function. Although highly logical, since source control is the best way to reduce quickly the bacterial inoculum, most recommendations are, however, graded as D or E due to the difficulty to perform appropriate randomized clinical trials in this respect. Appropriate source control should be part of the systematic checklist we have to keep in mind in setting up the therapeutic strategy in sepsis.
Abdomen↗
Bile duct injury during cholecystectomy and survival in medicare beneficiaries.
CONTEXT: Common bile duct (CBD) injury during cholecystectomy is a significant source of patient morbidity, but its impact on survival is unclear. OBJECTIVE: To demonstrate the relation between CBD injury and survival and to identify the factors associated with improved survival among Medicare beneficiaries. DESIGN, SETTING, AND PATIENTS: Retrospective study using Medicare National Claims History Part B data (January 1, 1992, through December 31, 1999) linked to death records and to the American Medical Association's (AMA's) Physician Masterfile. Records with a procedure code for cholecystectomy were reviewed and those with an additional procedure code for repair of the CBD within 365 days were defined as having a CBD injury. MAIN OUTCOME MEASURE: Survival after cholecystectomy, controlling for patient (sex, age, comorbidity index, disease severity) and surgeon (procedure year, case order, surgeon specialty) characteristics. RESULTS: Of the 1 570 361 patients identified as having had a cholecystectomy (62.9% women), 7911 patients (0.5%) had CBD injuries. The entire population had a mean (SD) age of 71.4 (10.2) years. Thirty-three percent of all patients died within the 9.2-year follow-up period (median survival, 5.6 years; interquartile range, 3.2-7.4 years), with 55.2% of patients without and 19.5% with a CBD injury remained alive. The adjusted hazard ratio (HR) for death during the follow-up period was significantly higher (2.79; 95% confidence interval [CI]; 2.71-2.88) for patients with a CBD injury than those without CBD injury. The hazard significantly increased with advancing age and comorbidities and decreased with the experience of the repairing surgeon. The adjusted hazard of death during the follow-up period was 11% greater (HR, 1.11; 95% CI, 1.02-1.20) if the repairing surgeon was the same as the injuring surgeon. CONCLUSIONS: The association between CBD injury during cholecystectomy and survival among Medicare beneficiaries is stronger than suggested by previous reports. Referring patients with CBD injuries to surgeons or institutions with greater experience in CBD repair may represent a system-level opportunity to improve outcome.
Aged↗
Guidelines for the selection of anti-infective agents for complicated intra-abdominal infections.
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Abdominal Abscess↗
Intraoperative cholangiography and risk of common bile duct injury during cholecystectomy.
CONTEXT: Intraoperative cholangiography (IOC) may decrease the risk of common bile duct (CBD) injury during cholecystectomy by helping to avoid misidentification of the CBD. OBJECTIVE: To characterize the relationship of IOC use and CBD injury while controlling for patient and surgeon characteristics. DESIGN, SETTING, AND PATIENTS: Retrospective nationwide cohort analysis of Medicare patients undergoing cholecystectomy from January 1, 1992, to December 31, 1999. Patients were identified using Current Procedural Terminology codes from the Medicare Part B depository. Common bile duct injury was defined by a second surgical procedure to repair the CBD injury within 1 year of cholecystectomy. Surgeon demographic features were obtained from matching the Medicare Part B data to the American Medical Association Physician Masterfile database. MAIN OUTCOME MEASURE: Frequency of CBD injury in patients who did and did not have IOC performed during cholecystectomy, controlling for patient-level (age, sex, race, and case complexity) and surgeon-level (surgeon's age, sex, race, year of surgical procedure, case order, percentage of IOC use in prior surgical procedures, years in medical practice, board certification, and specialization) factors. RESULTS: The database search identified 1 570 361 cholecystectomies and 7911 CBD injuries (0.5%). Common bile duct injury was found in 2380 (0.39%) of 613 706 patients undergoing cholecystectomy with IOC and in 5531 (0.58%) of 956 655 patients undergoing cholecystectomy without IOC (unadjusted relative risk, 1.49; 95% confidence interval, 1.42-1.57). After controlling for patient-level factors and surgeon-level factors, the risk of injury was increased when IOC was not used (adjusted relative risk, 1.71; 95% confidence interval, 1.38-2.28). While surgeons performing IOCs routinely had a lower rate of CBD injuries than those who did not, this difference disappeared when IOC was not used. CONCLUSIONS: In this study of Medicare patients undergoing cholecystectomy in the 1990s, the risk of CBD injury was significantly higher when IOC was not used. Although IOCs may not prevent all CBD injuries, this study suggests that the routine use of IOC may decrease the rate of CBD injury.
Aged↗
Trials and tribulations: current challenges in conducting clinical trials.
Randomized controlled trials are the gold standard for the evaluation of new therapies and surgical procedures and as such require strict attention to study design and statistical analysis. There are, however, multiple challenges in conducting a well-designed clinical trial. This article describes the difficulties encountered at a single institution participating in a multicenter drug study and reviews the challenges involved in developing a high-quality randomized controlled study.
Acetaminophen↗
Prevalence and predictors of asymptomatic liver disease in patients undergoing gastric bypass surgery.
BACKGROUND: Nonalcoholic steatohepatitis (NASH) is a form of fatty liver disease that is increasingly recognized. There are limited data on the prevalence of NASH and the role of risk factors for NASH among the morbidly obese. HYPOTHESIS: The prevalence of asymptomatic NASH among morbidly obese patients undergoing gastric bypass surgery is high, and there are identifiable risk factors for NASH. DESIGN: Prospective case study. SETTING: University hospital. PATIENTS: Forty-eight consecutive patients undergoing gastric bypass surgery who had a concurrent open liver biopsy. Exclusion criteria included current consumption of more than 2 alcohol beverages monthly and known cirrhosis. A hepatopathologist blinded to clinical data reviewed biopsy specimens. MAIN OUTCOME MEASURES: The presence of NASH or severe fibrosis, preoperative body mass index (BMI) (calculated as weight in kilograms divided by the square of height in meters), fasting triglyceride level, and presence of type 2 diabetes mellitus (DM). RESULTS: Patients (mean +/- SD age, 42 +/- 10 years; 33 women) had an initial mean BMI of 59.9 +/- 12. Thirty-one patients (65%) had moderate to severe steatosis. Only 6 (12%) had advanced fibrosis. Sixteen (33%) had evidence of NASH. There was no difference in mean age, sex, BMI, or fasting triglyceride level between patients with and without NASH or advanced fibrosis. The odds of NASH were 128 times greater (95% confidence interval [CI], 5.2-3137.0) and the odds of severe fibrosis 75 times greater (95% CI, 4.5-1247.0) in patients with DM than in those without DM. Preoperative BMI was not independently associated with NASH (odds ratio, 1.01; 95% CI, 0.9-1.1) or severe fibrosis (odds ratio, 0.9; 95% CI, 0.86-1.02) after adjustment for DM. CONCLUSIONS: Moderate to severe hepatic steatosis and NASH are common among individuals undergoing gastric bypass procedures. Diabetes mellitus but not BMI is associated with NASH and advanced hepatic fibrosis in these patients.
Adult↗