Aspirin and risk of hemorrhagic stroke: a meta-analysis of randomized controlled trials

CONTEXT: Aspirin has been widely used to prevent myocardial infarction and ischemic stroke but some studies have suggested it increases risk of hemorrhagic stroke. OBJECTIVE: To estimate the risk of hemorrhagic stroke associated with aspirin treatment. DATA SOURCES: Studies were retrieved using MEDLINE (search terms, aspirin, cerebrovascular disorders, and stroke), bibliographies of the articles retrieved, and the authors' reference files. STUDY SELECTION: All trials published in English-language journals before July 1997 in which participants were randomized to aspirin or a control treatment for at least 1 month and in which the incidence of stroke subtype was reported. DATA EXTRACTION: Information on country of origin, sample size, duration, study design, aspirin dosage, participant characteristics, and outcomes was abstracted independently by 2 authors who used a standardized protocol. DATA SYNTHESIS: Data from 16 trials with 55462 participants and 108 hemorrhagic stroke cases were analyzed. The mean dosage of aspirin was 273 mg/d and mean duration of treatment was 37 months. Aspirin use was associated with an absolute risk reduction in myocardial infarction of 137 events per 10000 persons (95% confidence interval [CI], 107-167; P<.001) and in ischemic stroke, a reduction of 39 events per 10000 persons (95% CI, 17-61; P<.001). However, aspirin treatment was also associated with an absolute risk increase in hemorrhagic stroke of 12 events per 10000 persons (95% CI, 5-20; P<.001). This risk did not differ by participant or study design characteristics. CONCLUSIONS: These results indicate that aspirin therapy increases the risk of hemorrhagic stroke. However, the overall benefit of aspirin use on myocardial infarction and ischemic stroke may outweigh its adverse effects on risk of hemorrhagic stroke in most populations.     

Management of intermittent claudication with pentoxifylline: meta-analysis of randomized controlled trials

OBJECTIVE: To evaluate the efficacy of pentoxifylline therapy in improving the walking capacity of patients with moderate intermittent claudication. DATA SOURCES: A search of MEDLINE for trials published between 1976 and 1994 inclusive, and a bibliographic review of all articles retrieved. STUDY SELECTION: Randomized, placebo-controlled, double-blind clinical trials were selected that evaluated the pain-free walking distance (the distanced walked on a treadmill before the onset of calf pain) and the absolute claudication distance (the maximum distance walked on a treadmill) among patients with moderate intermittent claudication. Twelve study groups in 11 trials were included in the analysis. DATA EXTRACTION: In addition to information regarding the trial design, patient characteristics, dosages and treatment periods, the means and standard deviations were collected for both the pain-free walking and absolute claudication distances. Trial quality was also assessed. DATA SYNTHESIS: Overall, there was a statistically significant improvement in the pain-free walking distance after pentoxifylline therapy (weighted mean difference 29.4 m [95% confidence interval (CI) 13.0 to 45.9 m]); this finding was based on a total sample of 612 patients (308 in the treatment groups and 304 in the control groups). A significant improvement was also noted in the absolute claudication distance (weighted mean difference 48.4 m [95% CI 18.3 to 78.6 m]); this was based on a total sample of 511 patients (258 in the treatment group and 253 in the control group). In a sensitivity analysis of the pain-free walking distance, significant treatment effects and no statistically significant heterogeneity were found when only trials were included that were "medically eligible" (involved patients with stage II disease and a pain-free walking distance of 50 to 200 m). In a similar sensitivity analysis of the absolute claudication distance, the two conditions resulting in a significant treatment effect and no significant heterogeneity were the inclusion of "medically eligible" trials and those with a shorter treatment duration (13 weeks or less). CONCLUSION: Pentoxifylline therapy may be efficacious in improving the walking capacity of patients with moderate intermittent claudication. However, properly conducted clinical trials are required to provide a true estimate of the benefit.     

Effect of reduced dietary sodium on blood pressure: a meta-analysis of randomized controlled trials

OBJECTIVE:- To ascertain whether restriction of dietary sodium lowers blood pressure in hypertensive and normotensive individuals. DATA SOURCES:- An English-language computerized literature search, restricted to human studies with Medical Subject Heading terms, "hypertension," "blood pressure," "vascular resistance," "sodium and dietary," "diet and sodium restricted," "sodium chloride," "clinical trial," "randomized controlled trial," and "prospective studies," was conducted. Bibliographies of review articles and personal files were also searched. TRIAL SELECTION:- Trials that had randomized allocation to control and dietary sodium intervention groups, monitored by timed sodium excretion, with outcome measures of both systolic and diastolic blood pressure were selected by blinded review of the methods section. DATA EXTRACTION:- Two observers extracted data independently, using purpose-designed forms, and discrepancies were resolved by discussion. DATA SYNTHESIS:- The 56 trials that met our inclusion criteria showed significant heterogeneity. Publication bias was also evident. The mean reduction (95% confidence interval) in daily urinary sodium excretion, a proxy measure of dietary sodium intake, was 95 mmol/d (71-119 mmol/d) in 28 trials with 1131 hypertensive subjects and 125 mmol/d (95-156 mmol/d) in 28 trials with 2374 normotensive subjects. After adjustment for measurement error of urinary sodium excretion, the decrease in blood pressure for a 100-mmol/d reduction in daily sodium excretion was 3.7 mm Hg (2.35-5.05 mm Hg) for systolic (P<.001) and 0.9 mm Hg (-0.13 to 1.85 mm Hg) for diastolic (P=.09) in the hypertensive trials, and 1.0 mm Hg (0.51-1.56 mm Hg) for systolic (P<.001) and 0.1 mm Hg (-0.32 to 0.51 mm Hg) for diastolic (P=.64) in the normotensive trials. Decreases in blood pressure were larger in trials of older hypertensive individuals and small and nonsignificant in trials of normotensive individuals whose meals were prepared and who lived outside the institutional setting. CONCLUSION:- Dietary sodium restriction for older hypertensive individuals might be considered, but the evidence in the normotensive population does not support current recommendations for universal dietary sodium restriction.     

Stress management interventions for HIV+ adults: A meta-analysis of randomized controlled trials, 1989 to 2006.

Objective: Numerous studies document that stress accelerates disease processes in a variety of diseases including HIV. As a result, investigators have developed and evaluated interventions to reduce stress as a means to improve health among persons living with HIV. Therefore, the current meta-analysis examines the impact of stress-management interventions at improving psychological, immunological, hormonal, and other behavioral health outcomes among HIV= adults. Design: This meta-analytic review integrated the results of 35 randomized controlled trials examining the efficacy of 46 separate stress management interventions for HIV+ adults (N = 3,077). Main Outcome Measures: Effect sizes were calculated for stress processes (coping and social support), psychological/psychosocial (anxiety, depression, distress, and quality of life), immunological (CD4+ counts and viral load), hormonal (cortisol, dehydroepiandrosterone sulfate [DHEA-S], cortisol/DHEA-S ratio, and testosterone) and other behavioral health outcomes (fatigue). Results: Compared to controls, stress-management interventions reduce anxiety, depression, distress, and fatigue and improve quality of life (d+s + 0.16 to 0.38). Stress-management interventions do not appear to improve CD4+ counts, viral load, or hormonal outcomes compared with controls. Conclusion: Overall, stress-management interventions for HIV+ adults significantly improve mental health and quality of life but do not alter immunological or hormonal processes. The absence of immunological or hormonal benefits may reflect the studies' limited assessment period (measured typically within 1-week postintervention), participants' advanced stage of HIV (HIV+ status known for an average of 5 years), and/or sample characteristics (predominately male and White participants). Future research might test these hypotheses and refine our understanding of stress processes and their amelioration. (PsycINFO Database Record (c) 2010 APA, all rights reserved)     

Risk factors for early infection of central venous catheters in pediatric patients

OBJECTIVE: To compare standard nurse-based pain therapy with a patient-controlled analgesia (PCA) regimen. DESIGN: Prospective, randomized study. SETTING: Single-institutional, clinical investigation in an urban, university-affiliated hospital. PARTICIPANTS: Sixty patients undergoing elective first-time cardiac surgery were included. INTERVENTIONS: In 30 patients, a standard analgesic regimen was used, and in 30 patients, a PCA regimen was used. The perioperative and postoperative management was similar for all patients. MEASUREMENTS AND MAIN RESULTS: Degree of sedation, satisfaction, and pain (by visual analog scale [VAS]) was assessed within the first 3 postoperative days. Vital capacity (VC) and forced expiratory volume in 1 second (FEV1) were measured using a portable spirometry system. Cortisol and troponin T (TnT) plasma levels were also measured. The expectation of pain was similar in both groups, and the postoperative pain score was significantly lower in the PCA than in the standard group throughout the study period. Significantly more piritramid was used in the PCA (total, 75.6 +/- 33.4 mg) than in the standard group (total, 20.1 +/- 31.9 mg). VC and FEV1 were significantly lower in the standard group compared with the PCA patients. Cortisol and TnT plasma levels were similar in both groups. Frequency of side effects were similar for both groups. CONCLUSION: Because of the beneficial effects with regard to degree of pain and satisfaction, pain management using PCA systems can be recommended for cardiac surgery patients. It appears to be superior to standard nurse-based pain therapy.     

Benefit of screening mammography in women aged 40-49: a new meta-analysis of randomized controlled trials

Eight randomized controlled trials (RCTs) of screening mammography have been conducted involving women aged 40-49 at entry. Current data are now available from these trials at 10.5 to 18 years of follow-up (average follow-up time: 12.7 years). Meta-analysis has been performed using a Mantel-Haenszel estimator method to combine current follow-up data from the eight RCTs of mammography that included women aged 40-49 at entry, including new follow-up data presented at the NIH Consensus Development Conference held January 21-23, 1997. Combining the most recent follow-up data on women aged 40-49 at entry into all eight RCTs yields a statistically significant 18% mortality reduction among women invited to screening mammography (relative risk: 0.82; 95% confidence interval: 0.71-0.95). Combining all current follow-up data on women aged 40-49 at entry into the five Swedish RCTs yields a statistically significantly 29% mortality reduction among women invited to screening (relative risk: 0.71; 95% confidence interval: 0.57-0.89). Meta-analysis including the most recent follow-up data from all eight RCTs involving women aged 40-49 at entry demonstrates for the first time a statistically significant mortality reduction due to regular screening mammography in women of this age group.     

Cholesterol reduction and the risk for stroke in men. A meta-analysis of randomized, controlled trials

OBJECTIVE: Reducing serum cholesterol lowers the risk for ischemic heart disease, but its effects on other vascular diseases are unknown. Published trials were reviewed to determine the effect of cholesterol-lowering interventions on fatal and nonfatal stroke. DESIGN: Meta-analysis of randomized, controlled trials. DATA IDENTIFICATION: A literature search of English-language studies examining the effect of modified diets or medications on cardiovascular end points from 1965 to 1992 using MEDLINE and a review of references of five quantitative overviews of cholesterol reduction and coronary disease. DATA ANALYSIS: Thirteen studies met three eligibility criteria: patients randomized to intervention or control; fatal or nonfatal stroke reported separately; and end points assessed without knowledge of treatment status. Heterogeneity among studies and overall effects of treatment on fatal and nonfatal stroke were estimated using the Mantel-Haenszel-Peto method to combine independent study results. The influence of various study designs and interventions was explored using subgroup comparisons. RESULTS: For fatal stroke, the overall odds ratio associated with cholesterol-lowering interventions in 13 trials was 1.32 (95% Cl, 0.94 to 1.86), and the odds ratio for the 10 single-intervention trials was 1.34 (Cl, 0.91 to 1.96). Among eight trials reporting nonfatal events, the summary odds ratio for nonfatal stroke for treated participants compared with controls was 0.88 (Cl, 0.70 to 1.11), and the odds ratio for total strokes was 0.98 (Cl, 0.80 to 1.19). Among three trials using clofibrate, treatment significantly increased the risk for fatal stroke (odds ratio, 2.64; Cl, 1.42 to 4.92) but not for nonfatal stroke (odds ratio, 0.87; Cl, 0.61 to 1.26). Regression analysis showed no statistical association between the magnitude of cholesterol reduction and the risk for fatal stroke. CONCLUSIONS: Lowering serum cholesterol through modified diets or medications does not reduce stroke mortality or morbidity in middle-aged men. Clofibrate appears to increase the risk for fatal strokes, but the mechanism for this effect is unknown.     

Cardiac tamponade: a rare but life-threatening complication of central venous catheters in children

The widespread use of central venous catheters in the treatment of pediatric patients has caused an increased incidence of complications. A rare, but potentially fatal complication occurs when the heart is perforated by the catheter tip causing a cardiac tamponade. This perforation of the heart generally is associated with the insertion procedure, but may also occur after some time because of displacement of the catheter tip. The authors present three cases in which the placement of a central venous catheter resulted in lethal cardiac tamponade. Proper positioning of the catheter tip in the superior vena cava and a high index of suspicion are essential in preventing this serious complication. Contrast-enhanced chest x-ray after insertion of the catheter must be performed to ascertain a correct position of the tip.     

Catheter infection in intensive care: influence of systematic replacement of central venous catheters on a guide wire every 4 days

OBJECTIVES: Determine whether systematic replacement of central venous catheters on a guide wire every 4 days leads to a lower rate of catheter infection. METHODS: We conducted a prospective randomized study comparing systematic catheter replacement with the standard procedure where one-way catheters are left in situ as needed. RESULTS: The study included 150 patients and 170 catheters. Catheter replacement on a guide wire was performed 169 times. The rate of infection was not significantly different between the group of patients with replacement (3.7 for 1000 catheter days) and the group with systematic replacement (5.4 for 1000 catheter days). No mechanical complications occurred during the replacement procedures on guide wires. CONCLUSION: We do not recommend systematically replacing catheters on a guide wire for the prevention of catheter infection. This procedure may however be indicated in case of suspected catheter infection as no mechanical of infectious complications occurred.     

Management of steroid-dependent asthma with methotrexate: a meta-analysis of randomized clinical trials

Our objective was to determine whether methotrexate is an effective steroid-sparing agent for patients with severe asthma. Published reports of controlled trials assessing the use of methotrexate in asthma were identified by a search of the MEDLINE, EMBASE, CINAHL, Biological Abstracts on CD, and Current Contents databases. Bibliographies from identified studies and from review articles were manually searched. Published and unpublished reports in any language were identified and assessed for inclusion in the meta-analysis. We selected randomized, double-blind, placebo-controlled trials in which low-dose methotrexate was administered to corticosteroid-dependent asthmatics, and oral steroids were subsequently tapered according to the patients' clinical status. Data were extracted independently by two reviewers. For all eligible trials, the mean reduction in oral corticosteroid dose, the mean change in FEV1, and the standard deviations, were calculated for the treatment and control groups. Data concerning side-effects of therapy were also extracted. Data from 12 studies, reporting on a total of 250 patients, were pooled using a weighted average method, with weights proportional to the inverse of the variance of the treatment effect. Compared to placebo, the use of methotrexate was associated with a pooled 6.0% improvement in FEV1 (95% CI, 1.0-11%) and an 18.2% reduction in oral steroid use (95% CI, 11.7-24.7%). This corresponded to a 3.3 mg day-1 greater reduction in oral steroid use for patients taking methotrexate than for those taking placebo (95% CI, 2.1-4.4 mg day-1). Gastrointestinal complications and transient increases in liver enzymes were more common in patients randomized to methotrexate. Three potentially life-threatening side-effects (two pneumonias and one liver dysfunction) occurred in 159 patients randomized to methotrexate vs. none in those patients on placebo. It was concluded that methotrexate allowed a modest reduction in oral corticosteroid compared to patients receiving placebo. The benefit is relatively small, however, and should be balanced against the potential for side-effects associated with the use of methotrexate.     

Effects of psychotherapeutic treatments for PTSD: a meta-analysis of controlled clinical trials

This meta-analysis synthesized the results from controlled, clinical trials of psychotherapeutic treatments for posttraumatic stress disorder (PTSD). Psychotherapeutic modalities included behavioral, cognitive, and psychodynamic treatments, in group and individual settings. Participants in the studies included combat veterans from the Vietnam and Lebanon Wars, crime-related victims, and severe bereavement sufferers. The impact of psychotherapy on PTSD and psychiatric symptomatology was significant, d = .52, r = .25, when measured immediately after treatments were administered. Similarly, there was no decay in the effect of treatment at follow-up, d = .64, r = .31. Moreover, for target symptomes of PTSD and general psychological symptomes (intrusion, avoidance, hyperarousal, anxiety, and depression), effect sizes were significant, ranging from r's of .2-.49. Results suggest substantial promise for improving psychological health and decreasing related symptoms for those suffering from PTSD.     

Are results of randomized controlled trials useful to psychotherapists?

Two clinicians provided opposite answers to the title question: Persons argued that information from randomized controlled trials (RCTs) is vital to clinicians, and Silberschatz argued that information from RCTs is irrelevant to clinicians. Persons argued that clinicians cannot provide top quality care to their patients without attending to findings of RCTs and that clinicians have an ethical responsibility to inform patients about, recommend, and provide treatments supported by RCTs before informing patients about, recommending, and providing treatments shown to be inferior in RCTs or not evaluated in RCTs. Silberschatz argued that RCTs do not and cannot answer questions that concern practicing clinicians. He advocates alternative research approaches (effectiveness studies, quasi-experimental methods, case-specific research) for studying psychotherapy. (PsycINFO Database Record (c) 2010 APA, all rights reserved)     

A randomized, controlled trial of a behavioral intervention to prevent sexually transmitted disease among minority women

Using annual bite-wing radiographs, the incidence and progression of approximal caries (4d-7m) were assessed longitudinally in teenagers and adolescents whose treatment had been based on remineralizing rather than restorative strategies. A closed cohort of 536 children initially was followed from 11 to 22 years of age. The scoring system was: 0 = no visible radiolucency; 1-2 = radiolucency in the enamel up to the enamel-dentin border; 3 = radiolucency with a broken enamel-dentin border but with no obvious progression in the dentin; 4 = radiolucency with obvious spread in the outer half of the dentin, and 5 = radiolucency in the inner half of the dentin. Caries rates were estimated as the number of new lesions/100 tooth surface-years, and the Kaplan-Meier estimate was used to calculate the cumulative survival time of each approximal surface. Three events were used: the transitions from states 0 to 2, 2 to 4 and 3 to 4. The results showed a considerable variation between the surfaces in both caries rates and survival time. For all surfaces combined, the median caries rate from state 0 to 2 was 3.9 new lesions/100 tooth surface-years; from state 2 to 4, the rate was 5.4, and from state 3 to 4 it was 20.3. Of the sound surfaces (state 0), 75% survived 6.3 years without reaching state 2. Given state 2, 75% survived 4.8 years without reaching the outer half of the dentin (state 4), while given a lesion at the enamel-dentin border (state 3), 75% survived 1.3 years without doing the same. The median survival time of lesions from state 3 to 4 was 3.1 years. The group with DMFSappr>1 at the age of 11-12 years had a risk of new approximal enamel lesions (state 0-2) that was 2.5 times greater than that of the group with DMFSappr = 0-1.     

Assessment of detection of Candida mannoproteinemia as a method to differentiate central venous catheter-related candidemia from invasive disease

The proper management of candidemic patients is controversial because of the difficulties of an early differentiation of central venous catheter (CVC)-related candidemia from deep-seated invasive Candida infection. In particular, more information on possible markers of invasive disease is needed. We performed a retrospective, pilot investigation to assess the diagnostic potential of a dot immunobinding assay for Candida mannoprotein antigen in serial serum samples from 31 candidemic patients in the setting of hematologic malignancy. Mannoproteinemia (antigenemia) was detected in 1 of 14 (7.1%) patients with transient or CVC-related candidemia and in 13 of 17 (76.5%) patients with non-CVC-related persistent candidemia. Of the 11 subjects of this latter group with documented tissue invasion, 10 (91%) were antigenemic. The patients belonging to the different categories did not significantly differ in the duration of candidemia, nor was there any significant difference among the different groups of subjects either in the number of serum samples examined or in their collection time during candidemia. The day of the first antigenemic sample during candidemia greatly varied among subjects with invasive infection, although on average mannoproteinemia was detectable by the first week of candidemia. In summary, our data demonstrate a correlation between mannoproteinemia and tissue invasion by Candida spp. in candidemic patients and suggest that mannoprotein detection by our method has a potential for the diagnosis of invasive candidiasis in these subjects.     

Complications of indwelling, silastic central venous access catheters in dogs and cats

RATIONALE AND OBJECTIVES: We investigated the effects of various metallic stents on the aortic wall. METHODS: The wires of Gianturco-type expandable metallic stents were plated with gold, silver, or copper or coated with Teflon or silicone. Stents were inserted into the aortas of 15 adult mongrel dogs. The time course of radiologic, macroscopic, and histologic changes in the aorta at the site of the stent was investigated at 1, 2, and 4 weeks after implantation. RESULTS: The gold-plated stent appeared to produce fewer macroscopic and histopathologic changes in the aorta than the other types of stents. The neointima was thinnest with gold (83.9 +/- 40.3 microns), followed by stainless steel (103.6 +/- 57.0 microns), Teflon (115.0 +/- 30.2 microns), silicone (209.6 +/- 25.9 microns), silver (228.6 +/- 33.8 microns), and copper (unmeasurable). With the copper-plated stent, the aorta suffered severe erosion of the vessel wall, marked thrombus formation, and aortic rupture. CONCLUSION: Gold is a useful intravascular material because it reacts only minimally with the vessel wall.     

Yohimbine for erectile dysfunction: a systematic review and meta-analysis of randomized clinical trials

Well-founded pharmacokinetic information is one of the cornerstones of a New Drug Application (NDA) to the Food and Drug Administration (FDA) required to introduce a new drug or a generic equivalent (ANDA) to the marketplace. The service that laboratories engaged in therapeutic drug monitoring provide to support clinical activities is also needed by the pharmaceutical industry during the evaluation and introduction of drugs to the marketplace. In considering this alternative service activity, one must be aware of and compliant with rules established by the FDA for performance of such studies. As specified in CFR 21, Parts 58, 211, and 320, good clinical and laboratory practice indicates that the laboratory should employ a Lab Study Director, who is responsible for the validation of all procedures implemented to support a study protocol, ensures that the laboratory carries out the study following these defined procedures, and personally reviews the results of all testing. The laboratory must validate each procedure by demonstrating and documenting that the procedure does what it is designed to do while meeting the analytical performance specifications required by the study. Laboratory records of all activities must be maintained and available for inspection by the FDA on request. The FDA has authority over all activities related to NDA and ANDA submissions and can bring criminal charges if results of a study are changed because a laboratory deviates from standard procedure. Competent drug monitoring laboratories are fully capable of participating in clinical trials testing activities. Laboratory staff should be fully versed in the FDA rules governing these activities, validate all procedures, and establish systems to verify the procedures are carried out as specified.     

Antimicrobial prophylaxis in colorectal surgery: a systematic review of randomized controlled trials

BACKGROUND: A systematic review was carried out to assess the relative efficacy of antimicrobial prophylaxis for the prevention of postoperative wound infection in patients undergoing colorectal surgery. METHODS: MEDLINE, EMBASE, the Cochrane Trials Register and the references cited in retrieved studies were searched to identify relevant trials published between 1984 and 1995. RESULTS: Some 147 relevant trials were identified. The quality of trials has improved over the past 12 years. The results confirm that the use of antimicrobial prophylaxis is effective for the prevention of surgical wound infection after colorectal surgery. There was no significant difference in the rate of surgical wound infections between many different regimens. However, certain regimens appear to be inadequate (e.g. metronidazole alone, doxycycline alone, piperacillin alone, oral neomycin plus erythromycin on the day before operation). A single dose administered immediately before the operation (or short-term use) is as effective as long-term postoperative antimicrobial prophylaxis (odds ratio 1.17 (95 per cent confidence interval (c.i.) 0.90-1.53)). There is no convincing evidence to suggest that the new-generation cephalosporins are more effective than first-generation cephalosporins (odds ratio 1.07 (95 per cent c.i. 0.54-2.12)). CONCLUSION: Antibiotics selected for prophylaxis in colorectal surgery should be active against both aerobic and anaerobic bacteria. Administration should be timed to make sure that the tissue concentration of antibiotics around the wound area is sufficiently high when bacterial contamination occurs. Guidelines should be developed locally in order to achieve a more cost-effective use of antimicrobial prophylaxis in colorectal surgery.     

Percutaneous central venous catheters in neonates: a descriptive analysis and evaluation of predictors for sepsis

The article describes the experience with percutaneous central venous catheters in 565 neonates with birth weights of 400 to 6810 g. The catheter-related sepsis incidence was 19.1%, or 13.5 infections per 1000 catheter days. By discriminant function analysis, 86% of all neonates studied were correctly classified into the confirmed sepsis and no sepsis groups on the basis of six predictor variables. The model did not accurately predict the neonates who would develop confirmed sepsis. The weight at catheter insertion and length of time for which the catheter was in place were identified as variables that contributed significantly to differentiation between sepsis and no sepsis groups.     

Calcified catheter "cast": a rare complication of indwelling central venous catheters in infants

Peri-catheter calcification is an unusual and previously unreported complication of central venous (CV) catheterization in infants. A 1. 9 Fr Silastic CV catheter was placed in a term infant for administration of total parenteral nutrition and antibiotics following intra-abdominal sepsis. The catheter was removed, without complication, at a later date after another septic episode. Imaging studies performed in the investigation of a possible intra-abdominal abscess revealed a cylindrical density within a clot in the inferior vena cava (IVC). The density was presumed to be a retained catheter fragment. Further investigation indicated total occlusion of the IVC. Surgical exploration of the IVC revealed only a calcified thrombus. This case represents a rare and previously unreported complication of CV catheterization in infants. Diagnosing this condition on radiographic evidence alone can be difficult. It is hoped that awareness of the potential for this complication will avoid unnecessary invasive procedures in the future. We also suggest a high level of clinical suspicion and routine Doppler ultrasound investigations to detect IVC thrombosis when indwelling CV catheters are used in infants.