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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:BackgroundThe correct identification of the appropriateness of fluid administration is important for the treatment of critically ill patients. Static and dynamic indices used to identify fluid responsiveness have been developed throughout the years, nonetheless fluid responsiveness does not indicate that fluid administration is appropriate, and indexes to evaluate appropriateness of fluid administration are lacking. The aim of this study was to evaluate if central venous pressure (CVP) anddynamic indices could correctly identify fluid appropriateness for critically ill patients.MethodsData from 31 ICU patients, for a total of 53 observations, was included in the analysis. Patients were divided into two cohorts based on the appropriateness of fluid administration. Fluid appropriateness was defined in presence of a low cardiac index (< 2.5 l/min/m2) without any sign of fluid overload, as assessed by global end-diastolic volume index, extravascular lung water index or pulmonary artery occlusion pressure.ResultsFor 10 patients, fluid administration was deemed appropriate, while for 21 patients it was deemed inappropriate. Central venous pressure was not different between the two cohorts (mean CVP 11 (4) mmHg in the fluid inappropriate group, 12 (4) mmHg in the fluid appropriate group, p 0.58). The same is true for pulse pressure variation (median PPV 5 [2, 9] % in the fluid inappropriate group, 4 [3, 13] % in the fluid appropriate group, p 0.57), for inferior vena cava distensibility (mean inferior vena cava distensibility 24 (14) % in the fluid inappropriate group, 22 (16) % in the fluid appropriate group, p 0.75) and for changes in end tidal carbon dioxide during a passive leg raising test (median d.ETCO2 1.5 [0.0, 2.0]% in the fluid inappropriate group, 1.0 [0.0, 2.0] % in the fluid appropriate group, p 0.98). There was no association between static and dynamic indices and fluid appropriateness.ConclusionsCentral venous pressure, pulse pressure variation, changes in end tidal carbon dioxide during a passive leg raising test, inferior vena cava distensibility were not associated with fluid appropriateness in our cohorts.

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.

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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