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Study protocol for a multicentre, randomised, controlled trial to assess the effectiveness of antimicrobial central venous catheters versus ordinary central venous catheters at reducing catheter related infections in critically ill Chinese patients.

ABSTRACT: INTRODUCTION:Catheter use is associated with many complications and is an iatrogenic source of morbidity and mortality in intensive care units (ICU). The catheter being studied (Certofix Protect) was developed to reduce the risk of catheter related infections. This clinical trial will compare the safety and efficiency of Certofix Protect with that of an ordinary Certofix catheter. METHODS AND ANALYSIS:In this multicentre trial, we will randomly assigned dual lumen central venous catheterisation (?5?ds) in patients in the adult ICU to the antimicrobial central venous catheter (CVC) group or the ordinary CVC group. We plan to recruit 12-16 medical centres in China. Our main objective is to assess the effectiveness of antimicrobial CVCs in reducing catheter related bloodstream infection (CRBSI), all cause mortality, catheter colonisation, catheter related thrombosis and other catheter related complications. The primary outcome is the incidence of CRBSI. ETHICS AND DISSEMINATION:The ethics committee of West China Hospital of Sichuan University has granted ethics approval for this study (27 January 2015). The results will be published in peer reviewed journals and presented at conferences. TRIAL REGISTRATION NUMBER:NCT02645682.

SUBMITTER: Wu M

PROVIDER: S-EPMC5778275 | biostudies-literature | 2017 Dec

REPOSITORIES: biostudies-literature

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Study protocol for a multicentre, randomised, controlled trial to assess the effectiveness of antimicrobial central venous catheters versus ordinary central venous catheters at reducing catheter related infections in critically ill Chinese patients.

Wu Minming M Chen Yao Y Du Bin B Kang Yan Y

BMJ open 20171229 12

<h4>Introduction</h4>Catheter use is associated with many complications and is an iatrogenic source of morbidity and mortality in intensive care units (ICU). The catheter being studied (Certofix Protect) was developed to reduce the risk of catheter related infections. This clinical trial will compare the safety and efficiency of Certofix Protect with that of an ordinary Certofix catheter.<h4>Methods and analysis</h4>In this multicentre trial, we will randomly assigned dual lumen central venous c ...[more]

PMID: 29289933

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Project description:Critically ill patients often undergo central venous catheter placement during thrombocytopenia and/or coagulopathy. It is unclear whether severe coagulopathy increases the risk of postprocedural bleeding in critically ill patients with severe thrombocytopenia.DesignSingle-center retrospective cohort study.SettingAcademic mixed ICU in Amsterdam, the Netherlands.PatientsConsecutive severely thrombocytopenic (platelet count ≤ 50 × 109/L) patients who underwent central venous catheter placement between February 2016 and February 2020.InterventionsCentral venous catheter placement in patients with both severe thrombocytopenia and severe coagulopathy (international normalized ratio > 1.5 and/or activated partial thromboplastin time > 45 s) versus patients with severe thrombocytopenia and normal or mildly prolonged international normalized ratio and activated partial thromboplastin time.Measurements and main resultsWe included 289 central venous catheter placements in 175 patients, 112 in patients with and 172 in patients without severe coagulopathy. Median (interquartile range) platelet count was 27 (16-38) and equal for both groups. There were 44 bleeding episodes at the central venous catheter insertion site (15.5%), of which four (1.4%) were grade 2 and two (0.7%) were grade 3. There were 19 bleeding episodes (17.0%) versus 25 bleeding episodes (14.5%) in the coagulopathy and noncoagulopathy groups, of which one and five were of grade 2 or higher, respectively. After correction for confounders, coagulopathy had no effect on bleeding: odds ratio (95% CI) 0.96 (0.24-3.88). Before central venous catheter placement, 116 (40.8%) patients received platelet transfusion. Bleeding at the central venous catheter insertion site occurred in 19 of 116 patients (16.4%) and 25 of 168 patients (14.9%) who did and did not receive platelet transfusion. After correction for confounders, platelet transfusion had no effect on bleeding: odds ratio (95% CI) 0.73 (0.18-2.83).ConclusionsCoagulopathy was not associated with an increased bleeding risk in severely thrombocytopenic ICU patients undergoing ultrasound guided central venous catheter placement. Prophylactic platelet transfusion in patients with severe thrombocytopenia was not associated with a reduced risk of bleeding.

Project description:IntroductionCatheter-related bloodstream infections (CRBSIs) associated with short-term central venous catheters (CVCs) in intensive care unit (ICU) patients are a major clinical problem. Bacterial colonization of the skin at the CVC insertion site is an important etiologic factor for CRBSI. The aim of this study was to assess the efficacy of medical-grade honey in reducing bacterial skin colonization at insertion sites.MethodsA prospective, single-center, open-label randomized controlled trial was performed at the ICU of a university hospital in The Netherlands to assess the efficacy of medical-grade honey to reduce skin colonization of insertion sites. Medical-grade honey was applied in addition to standard CVC-site dressing and disinfection with 0.5% chlorhexidine in 70% alcohol. Skin colonization was assessed on a daily basis before CVC-site disinfection. The primary end point was colonization of insertion sites with >100 colony-forming units at the last sampling before removal of the CVC or transfer of the patient from the ICU. Secondary end points were quantitative levels of colonization of the insertion sites and colonization of insertion sites stratified for CVC location.ResultsColonization of insertion sites was not affected by the use of medical-grade honey, as 44 (34%) of 129 and 36 (34%) of 106 patients in the honey and standard care groups, respectively, had a positive skin culture (P = 0.98). Median levels of skin colonization at the last sampling were 1 (0 to 2.84) and 1 (0 to 2.70) log colony-forming units (CFUs)/swab for the honey and control groups, respectively (P = 0.94). Gender, days of CVC placement, CVC location, and CVC type were predictive for a positive skin culture. Correction for these variables did not change the effect of honey on skin-culture positivity.ConclusionsMedical-grade honey does not affect colonization of the skin at CVC insertion sites in ICU patients when applied in addition to standard disinfection with 0.5% chlorhexidine in 70% alcohol.Trial registrationNetherlands Trial Registry, NTR1652.

Project description:OBJECTIVE:We performed a systematic review and meta-analysis to examine the accuracy of bedside ultrasound for confirmation of central venous catheter position and exclusion of pneumothorax compared with chest radiography. DATA SOURCES:PubMed, Embase, Cochrane Central Register of Controlled Trials, reference lists, conference proceedings and ClinicalTrials.gov. STUDY SELECTION:Articles and abstracts describing the diagnostic accuracy of bedside ultrasound compared with chest radiography for confirmation of central venous catheters in sufficient detail to reconstruct 2?×?2 contingency tables were reviewed. Primary outcomes included the accuracy of confirming catheter positioning and detecting a pneumothorax. Secondary outcomes included feasibility, interrater reliability, and efficiency to complete bedside ultrasound confirmation of central venous catheter position. DATA EXTRACTION:Investigators abstracted study details including research design and sonographic imaging technique to detect catheter malposition and procedure-related pneumothorax. Diagnostic accuracy measures included pooled sensitivity, specificity, positive likelihood ratio, and negative likelihood ratio. DATA SYNTHESIS:Fifteen studies with 1,553 central venous catheter placements were identified with a pooled sensitivity and specificity of catheter malposition by ultrasound of 0.82 (0.77-0.86) and 0.98 (0.97-0.99), respectively. The pooled positive and negative likelihood ratios of catheter malposition by ultrasound were 31.12 (14.72-65.78) and 0.25 (0.13-0.47). The sensitivity and specificity of ultrasound for pneumothorax detection was nearly 100% in the participating studies. Bedside ultrasound reduced mean central venous catheter confirmation time by 58.3 minutes. Risk of bias and clinical heterogeneity in the studies were high. CONCLUSIONS:Bedside ultrasound is faster than radiography at identifying pneumothorax after central venous catheter insertion. When a central venous catheter malposition exists, bedside ultrasound will identify four out of every five earlier than chest radiography.

Project description:BACKGROUND:Catheters are the most common cause of nosocomial infections and are associated with increased risk of mortality, length of hospital stay and cost. Prevention of infections and fast and correct diagnosis is highly important. METHODS:In this study traditional semiquantitative culture-dependent methods for diagnosis of bacteria involved in central venous catheter-related infections as described by Maki were compared with the following culture-independent molecular biological methods: Clone libraries, denaturant gradient gel electrophoresis, phylogeny and fluorescence in situ hybridization. RESULTS:In accordance with previous studies, the cultivation of central venous catheters from 18 patients revealed that S. epidermidis and other coagulase-negative staphylococci were most abundant and that a few other microorganisms such as P. aeruginosa and K. pneumoniae occasionally were found on the catheters. The molecular analysis using clone libraries and sequencing, denaturant gradient gel electrophoresis and sequencing provided several important results. The species found by cultivation were confirmed by molecular methods. However, many other bacteria belonging to the phyla Proteobacteria, Firmicutes, Actinobacteria and Bacteroidetes were also found, stressing that only a minor portion of the species present were found by cultivation. Some of these bacteria are known to be pathogens, some have not before been described in relation to human health, and some were not closely related to known pathogens and may represent new pathogenic species. Furthermore, there was a clear difference between the bacterial species found in biofilm on the external (exluminal) and internal (luminal) side of the central venous catheter, which can not be detected by Maki's method. Polymicrobial biofilms were observed on most of the catheters and were much more common than the cultivation-dependent methods indicated. CONCLUSION:The results show that diagnosis based on molecular methods improves the detection of microorganisms involved in central catheter-related infections. The importance of these microorganisms needs to be investigated further, also in relation to contamination risk from improper catheter handling, as only in vivo contaminants are of interest. This information can be used for development of fast and more reliable diagnostic tools, which can be used in combination with traditional methods.

Project description:BackgroundCentral venous oxygen saturation (ScvO2) is often used to help to guide resuscitation of critically ill patients. The standard gold technique for ScvO2 measurement is the co-oximetry (Co-oximetry_ScvO2), which is usually incorporated in most recent blood gas analyzers. However, in some hospitals, those machines are not available and only calculated ScvO2 (Calc_ScvO2) is provided. Therefore, we aimed to investigate the agreement between Co-oximetry_ScvO2 and Calc_ScvO2 in a general population of critically ill patients and septic shock patients.MethodsA total of 100 patients with a central venous catheter were included in the study. One hundred central venous blood samples were collected and analyzed using the same point-of-care blood gas analyzer, which provides both the calculated and measured ScvO2 values. Bland and Altman plot, intra-class correlation coefficient (ICC), and Cohen's Kappa coefficient were used to assess the agreement between Co-oximetry_ScvO2 and Calc_ScvO2. Multiple linear regression analysis was performed to investigate the independent explanatory variables of the difference between Co-oximetry_ScvO2 and Calc_ScvO2.ResultsIn all population, Bland and Altman's analysis showed poor agreement (+4.5 [-7.1, +16.1]%) between the two techniques. The ICC was 0.754 [(95% CI: 0.393-0.880), P< 0.001], and the Cohen's Kappa coefficient, after categorizing the two variables into two groups using a cutoff value of 70%, was 0.470 (P <0.001). In septic shock patients (49%), Bland and Altman's analysis also showed poor agreement (+5.6 [-6.7 to 17.8]%). The ICC was 0.720 [95% CI: 0.222-0.881], and the Cohen's Kappa coefficient was 0.501 (P <0.001). Four independent variables (PcvO2, Co-oximetry_ScvO2, venous pH, and Hb) were found to be associated with the difference between the measured and calculated ScvO2 (adjusted R2 = 0.8, P<0.001), with PcvO2 being the main independent explanatory variable because of its highest absolute standardized coefficient. The area under the receiver operator characteristic curves (AUC) of PcvO2 to predict Co-oximetry_ScvO2 ? 70% was 0.911 [95% CI: 0.837-0.959], in all patients, and 0.903 [95% CI: 0.784-0.969], in septic shock patients. The best cutoff value was ? 36 mmHg (sensitivity, 88%; specificity, 83%), in all patients, and ? 35 mmHg (sensitivity, 94%; specificity, 71%) in septic shock patients.ConclusionsThe discrepancy between the measured and calculated ScvO2 is clinically not acceptable. We do not recommend the use of calculated ScvO2 to guide resuscitation in critically ill patients. In situations where the Co-oximetry technique is not available, relying on PcvO2 to predict the measured ScvO2 value above or below 70% could be an option.

Project description:BACKGROUND: Central venous catheter (CVC) and hemodialysis (HD) catheter usage are associated with complications that occur during catheter insertion, dwell period, and removal. This study aims to identify and describe the incidence rates of catheter-related complications in a large patient population in a United States-based health care claims database after CVC or HD catheter placement. METHODS: Patients in the i3 InVision DataMart® health care claims database with at least 1 CVC or HD catheter insertion claim were categorized into CVC or HD cohorts using diagnostic and procedural codes from the US Renal Data System, American College of Surgeons, and American Medical Association's Physician Performance Measures. Catheter-related complications were identified using published diagnostic and procedural codes. Incidence rates (IRs)/1000 catheter-days were calculated for complications including catheter-related bloodstream infections (CRBSIs), thrombosis, embolism, intracranial hemorrhage (ICH), major bleeding (MB), and mechanical catheter-related complications (MCRCs). RESULTS: Thirty percent of the CVC cohort and 54% of the HD cohort had catheter placements lasting <90 days. Catheter-related complications occurred most often during the first 90 days of catheter placement. IRs were highest for CRBSIs in both cohorts (4.0 [95% CI, 3.7-4.3] and 5.1 [95% CI, 4.7-5.6], respectively). Other IRs in CVC and HD cohorts, respectively, were thrombosis, 1.3 and 0.8; MCRCs, 0.6 and 0.7; embolism, 0.4 and 0.5; MB, 0.1 and 0.3; and ICH, 0.1 in both cohorts. Patients with cancer at baseline had significantly higher IRs for CRBSIs and thrombosis than non-cancer patients. CVC or HD catheter-related complications were most frequently seen in patients 16 years or younger. CONCLUSIONS: The risk of catheter-related complications is highest during the first 90 days of catheter placement in patients with CVCs and HD catheters and in younger patients (?16 years of age) with HD catheters. Data provided in this study can be applied toward improving patient care.

Dataset Information

Study protocol for a multicentre, randomised, controlled trial to assess the effectiveness of antimicrobial central venous catheters versus ordinary central venous catheters at reducing catheter related infections in critically ill Chinese patients.

Publications

Study protocol for a multicentre, randomised, controlled trial to assess the effectiveness of antimicrobial central venous catheters versus ordinary central venous catheters at reducing catheter related infections in critically ill Chinese patients.

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