Antimicrobial central venous catheters in oncology: efficacy of a rifampicin-miconazole-releasing catheter.

UNLABELLED: Antimicrobial central venous catheters are discussed as a device to reduce catheter-related infections. Previously we have reported a study with 223 adult surgical patients randomized to receive either a rifampicin-miconazole-loaded central venous catheter (CVC) (n=118) or a standard CVC (n=105). The antimicrobial CVC was shown to reduce catheter colonization (CC) and catheter-related local infection (CRI) significantly even at long-term catheterization. Here, we present further evaluation of the study focusing on possible benefits for high-risk patients. Subgroup analyses showed a pronounced reduction of CC and CRI in male, overweight and oncology patients. Important covariates were skin colonization for CC and oncological disease for CRI. Odds ratio (OR) for reducing CC was 0.076 (95% CI: 0.016-0.360) and CRI was reduced from 26% to 2.3% (p=0.001) in the cancer subgroup. Ex vivo long-term antimicrobial activity of modified catheters exceeded 4 weeks. CONCLUSION: Immunocompromized patients suffering from cancer, transplantation, and dialysis patients with a long-term vascular access may mostly benefit from rifampicin-miconazole-releasing catheters.

Early coagulopathy in multiple injury: an analysis from the German Trauma Registry on 8724 patients.

BACKGROUND: There is increasing evidence for acute traumatic coagulopathy occurring prior to emergency room (ER) admission but detailed information is lacking. PATIENTS AND METHODS: A retrospective analysis using the German Trauma Registry database including 17,200 multiple injured patients was conducted to determine (a) to what extent clinically relevant coagulopathy has already been established upon ER admission, and whether its presence was associated (b) with the amount of intravenous fluids (i.v.) administered pre-clinically, (c) with the magnitude of injury, and (d) with impaired outcome and mortality. Eight thousand seven hundred and twenty-four patients with complete data sets were screened. RESULTS: Coagulopathy upon ER admission as defined by prothrombin time test (Quick's value) <70% and/or platelets <100,000 microl(-1), was present in 34.2% of all patients. There was an increasing incidence for coagulopathy with increasing amounts of i.v. fluids administered pre-clinically. Coagulopathy was observed in >40% of patients with >2000 ml, in >50% with >3000 ml, and in >70% with >4000 ml administered. Ten percentage of patients presented with clotting disorders although pre-clinical resuscitation was limited to 500 ml of i.v. fluids maximum. The mean ISS score in the coagulopathy group was 30 (S.D. 15) versus 21 (S.D. 12) (p<0.001). Twenty-nine percentage of patients with coagulopathy developed multi organ failure (p<0.001). Early in-hospital mortality (<24h) was 13% in patients with coagulopathy (p<0.001) and overall in-hospital mortality totalled 28% (p<0.001). CONCLUSION: There is a high frequency of established coagulopathy in multiple injury upon ER admission. The presence of early traumatic coagulopathy was associated with the amount of intravenous fluids administered pre-clinically, magnitude of injury, and impaired outcome.

Trauma Associated Severe Hemorrhage (TASH)-Score: probability of mass transfusion as surrogate for life threatening hemorrhage after multiple trauma.

BACKGROUND: To develop a simple scoring system that allows an early and reliable estimation for the probability of mass transfusion (MT) as a surrogate for life threatening hemorrhage following multiple trauma. METHODS: Potential clinical and laboratory variables documented in the Trauma Registry of the German Trauma Society (DGU) (1993-2003; n=17,200) were subjected to univariate and multivariate logistic regression analysis to predict the probability for MT. RESULTS: Clinical and laboratory variables available from data sets were screened for their association with mass transfusion. MT was defined by transfusion requirement of >or=10 units of packed red blood cells from emergency room (ER) to intensive care unit admission. Seven independent variables were identified to be significantly correlated with an increased probability for MT: systolic blood pressure (<100 mm Hg=4 pts, <120 mm Hg=1 pt), hemoglobin (<7 g/dL=8 pts, <9 g/dL=6 pts, <10 g/dL=4 pts, <11 g/dL=3 pts, and <12 g/dL=2 pts), intra-abdominal fluid (3 pts), complex long bone and/or pelvic fractures (AIS 3/4=3 pts and AIS 5=6 pts), heart rate (>120=2 pts), base excess (<-10 mmol/L=4 pts, <-6 mmol/L=3 pts, and <-2 mmol/L=1 pt), and gender (male=1 pt). These variables were incorporated into a risk score, the Trauma Associated Severe Hemorrhage Score (TASH-Score, 0-28 points). Performance of the score was tested with respect to discrimination, precision, and calibration. Increasing TASH-Score points were associated with an increasing probability for MT. CONCLUSION: The TASH-Score is an easy-to-use scoring system that reliably predicts the probability for MT after multiple trauma. Taken as a surrogate for life threatening bleeding calculation may focus attention on relevant variables indicative for risk and impact strategies to stop bleeding and stabilize coagulation in acute trauma care.

Functional treatment and early weightbearing after an ankle fracture: a prospective study.

OBJECTIVE: Postoperative care for ankle fractures is generally 1 of 2 regimens: 1) functional treatment combined with early weightbearing (EWB), or 2) immobilization in a cast/orthosis for 6 weeks without weightbearing (6WC). The objective of this study was 2-fold: 1) to follow a prospective group treated with EWB as to long-term subjective and objective outcomes, and 2) to compare a subset of this group with a matched group of historic controls treated with 6WC. DESIGN: Prospective, clinical, cohort observation, and retrospective matched pair analysis. SETTING: University hospital, level 1 trauma center. PATIENTS: Forty-three patients (20 males; mean age, 49 +/- 14 years) with operated Weber B/C fractures underwent EWB. For comparison, 23 patients of this group were matched to a same number of historic controls with respect to age, gender, body mass index, and fracture type. INTERVENTION: Open reduction and internal fixation (ORIF) using a 1/3-tubular-fibula-plate for the fibula, and malleolar screws for the medial malleolus fracture (in cases with a bimalleolar ankle fracture) followed by EWB or 6WC. MAIN OUTCOME MEASUREMENTS: Olerud and Tegner scores at follow-up (at least 12 months after surgery), time to full weightbearing, return to work, pain intensity (numerical rating scale (NRS)), and hospital stay. Statistical comparisons were performed by using the Mann-Whitney U test or Fisher exact test (P < 0.05). RESULTS: Patients with EWB were full weightbearing at 7 +/- 3 weeks and returned to work at 8 +/- 5 weeks after surgery. At follow-up (mean, 20 +/- 11 months after surgery), all EWB patients showed good results in the Olerud score (90 +/- 13 points). Matched-pair analysis in 23 patients in each group revealed differences between EWB and 6WC groups for hospital stay (mean, 10.8 +/- 4.7 vs. 13.6 +/- 6 days; P = 0.12), time to full weightbearing (mean, 7.7 +/- 3.1 vs. 13.5 +/- 9.4 weeks; P = 0.01), and time until return to work (mean 9.2 +/- 5.5 vs. 10.8 +/- 7 weeks; P = 0.63). No differences concerning pain intensities were observed (EWB vs. 6WC: NRS = 1.9 vs. 1.7; P = 0.12). At follow-up, Olerud scores were generally considered good for both groups; however, mean values in EWB patients were slightly higher (87 +/- 14 vs. 79 +/- 19 points; P = 0.25). In both groups, the majority of patients reached their preinjury level of activity as demonstrated by Tegner scores. CONCLUSIONS: EWB patients tolerated earlier full weightbearing compared with 6WC patients, and there were no disadvantages with EWB compared with 6WC concerning hospital stay, pain intensities, time until return to work, and Olerud/Tegner Scores. Potential candidates for EWB are patients with a stable osteosynthesis of their fractured ankles as judged by the responsible surgeon, compliance, and high motivation.

Evaluation of criteria for temporary external fixation in risk-adapted damage control orthopedic surgery of femur shaft fractures in multiple trauma patients: "evidence-based medicine" versus "reality" in the trauma registry of the German Trauma Society.

BACKGROUND: Femur-shaft fracture treatment (FSFT) follows controversial management concepts after multiple trauma: primary-definitive osteosynthesis, secondary-definitive osteosynthesis after temporary external fixation (EF) in all patients, or individualized primary- or secondary-definitive osteosynthesis ("risk-adapted damage control orthopedics"). This study compares the concepts by analyzing literature evidence and a prospective multicenter database. METHODS: A systematic literature analysis was performed. The German Trauma Society trauma registry was used to assess variables predictive of treatment concept. RESULTS: Contradictory results in 63 controlled trials failed to support a "generalized management strategy." In all, 1,465 FSFTs in 8,057 trauma registry patients (age 39 +/- 19.5 years; Injury Severity Score [ISS] 23.5 +/- 14.9; 17.3% mortality) were treated initially (<24 hour) by EF, nail, or plate in 47.0%, 41.1%, and 11.9%, respectively. Despite large interhospital variability, EF was more likely with increasing severity of ISS, Glasgow Coma Score, thorax trauma, base excess, coagulation abnormalities, and initial probability of death. CONCLUSIONS: Clinical "reality" reflects the controversies of "scientific evidence" for FSFT after multiple trauma in Germany. Although decision making is currently based on unvalidated criteria, anatomic and physiologic injury severity appears to influence the choice of management concept.

Reduced colonization and infection with miconazole-rifampicin modified central venous catheters: a randomized controlled clinical trial.

OBJECTIVE: Central venous catheters (CVC) are a major cause of nosocomial bloodstream infections. Catheters modified with miconazole and rifampicin that constantly and slowly release antimicrobial substances are assumed to be beneficial in reducing rates of colonization and catheter-related infections. DESIGN AND SETTING: Prospective controlled non-blinded randomized clinical trial in two German university hospitals. PATIENTS: 223 adult inpatients with CVC between October 2000 and February 2002. Baseline characteristics, APACHE II score and therapeutic interventions were comparable. INTERVENTION: Randomization to receive either a miconazole and rifampicin modified catheter (n=118) or a standard triple-lumen CVC (n=105). MEASUREMENTS, DEFINITIONS: Microbiological evaluation was done after CVC removal. A catheter was considered colonized if growth of > or =15 cfu was found by semi-quantitative roll-plate technique from a proximal or distal catheter segment. A catheter-related infection (CRI) was defined as a colonized catheter with local signs of inflammation. A catheter-related bloodstream infection (CR-BSI) was defined as a colonized catheter with isolation of the same organism from the patient's blood with accompanying clinical signs of infection. RESULTS: A colonization of CVC was observed in six patients (5.1%) with a modified catheter and 38 patients (36.2%) with a standard catheter (P < 0.001). Five patients in the modified group (4.2%) and 18 in the standard group (17.1%) developed CRI (P=0.002). One assumed CR-BSI was detected in the standard group, with none in the modified group. No adverse effects related to the modified catheters and no antimicrobial resistance were observed. CONCLUSION: CVC supersaturated with miconazole and rifampicin were associated with a significantly lower risk for catheter colonization and catheter-related infections compared to standard catheters.

Antiinfective and encrustation-inhibiting materials--myth and facts.

Catheters, urethral and ureteral stents and other urological implants are frequently affected by encrustration and infection due to their permanent contact with urine. Indwelling urinary catheters provide a haven for microorganisms and thus require extensive monitoring. Several surface modification techniques have been proposed to improve the performance of devices including the immobilization of biomolecules, the incorporation of hydrophilic grafts to reduce protein adsorption, the creation of hydrophobic surfaces, the creation of microdomains to regulate cellular and protein adhesion, new polymers and antimicrobial coatings. Physico-chemical explanation to elucidate the mechanism of such encrustation or infection inhibiting materials is still not available. Our series of experiments showed a marked decrease of silver-activity in biological fluids which corresponds with the controversial clinical results obtained with silver coated urinary catheters. Rifampicin/minocycline coated catheters had very low activity against Gram-negative rods, enterococci and Candida spp., the main causing organisms of urinary catheter infection. Surface engineered materials and antimicrobial drug delivery systems will be the next generation of sophisticated urinary catheters and stents, if both efficacy as well as efficiency has been proved clinically.

Esophageal motility and reflux symptoms before and after bariatric surgery.

BACKGROUND: Surgical treatment is the most effective method for weight reduction in morbid obesity. The most common operations are gastric banding and gastric bypass. The effect of these interventions on esophageal function and gastroesophageal reflux symptoms has not been adequately investigated. METHODS: Patients undergoing obesity surgery were prospectively included in an observational study. Before surgery, each of the 53 patients underwent pulmonary function tests, esophageal manometry, and gastroscopy. Drug medication and esophageal symptoms were recorded. "Non-sweet eater" patients with good compliance underwent laparoscopic adjustable gastric banding (LAGB). In "sweet-eating" or non-compliant patients, gastric bypass (GBP) was carried out. RESULTS: Between July 1997 and April 2000, 53 patients (9 males and 44 females) were consecutively operated on. 32 patients (median BMI 46.4 kg/m2 +/- 5.4 SD) received LAGB, and 21 patients (BMI 54.0 kg/m2 +/- 10.7) GBP. Median follow-up was 22 months, and only 3 patients were lost to yearly follow-up. Preoperatively, 6 LAGB patients had reflux symptoms, which postoperatively resolved in 3 of them, while the other 3 noted no change. Three patients who had no preoperative reflux symptoms developed them after LAGB. In the GBP group, no patient had esophageal dysmotility or incompetent esophageal sphincter function pre- or postoperatively. The incidence of postoperative esophageal symptoms was independent of operative technique (Wilcoxon U-Test: p = 0.75). CONCLUSION: The present results do not show any effect of gastric reduction surgery on postoperative esophageal function or gastroesophageal reflux symptoms.