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Chlorhexidine locking device for central line infection prevention in ICU patients: protocol for an open-label pilot and feasibility randomized controlled trial.

ABSTRACT: Background:Critically ill patients in the intensive care unit (ICU) are at risk for central line-associated bloodstream infection (CLABSI) with an incidence up to 6.9 per 1000 catheter days. CLABSI has a significant attributable mortality and increases in-hospital length of stay, readmissions, and costs. Chlorhexidine gluconate (CHG), a broad-spectrum biocide, has been shown to effectively reduce infections including CLABSI; however, few trials have utilized CHG for prevention of central line infections. Our preclinical work has demonstrated a device that diffuses CHG into the intravenous lock solution of central venous catheters and decreases bacterial growth on the catheter lumen. We designed a clinical trial to test the feasibility of using a CHG device in an ICU patient population. Methods:The proposed pilot trial will be a single centre, open-label, two-arm, parallel group feasibility randomized controlled trial (RCT). Participants will have a central line in situ and will be enrolled within 72 h of admittance to 3 ICUs at a single academic hospital. Exclusion criteria will include suspected infection, chronic indwelling catheters, and CHG allergy. Informed consent will be obtained from eligible participants or their substitute decision maker prior to randomization. Participants will be randomized to receive either usual care or the CHG locking device. Blood cultures will be drawn from all participants every 48 h. The primary objective of this study will be to determine the feasibility of using this protocol to conduct a larger trial. Feasibility will be assessed through the following outcomes: (1) consent rate, (2) recruitment rate, (3) protocol adherence, and (4) comfort level with the device. The secondary objective of this study will be to establish the preliminary efficacy of the device. Discussion:This study will be the first human RCT to investigate a CHG locking device for the prevention of central line infections. Findings from this trial will inform the feasibility of conducting a large RCT and provide preliminary data on the efficacy of a CHG locking device. Trial registration:ClinicalTrials.gov, NCT03309137, registered on October 13, 2017.

SUBMITTER: Zamir N

PROVIDER: S-EPMC7027059 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature

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Chlorhexidine locking device for central line infection prevention in ICU patients: protocol for an open-label pilot and feasibility randomized controlled trial.

Zamir Nasim N Pook Makena M McDonald Ellen E Fox-Robichaud Alison E AE

Pilot and feasibility studies 20200218

<h4>Background</h4>Critically ill patients in the intensive care unit (ICU) are at risk for central line-associated bloodstream infection (CLABSI) with an incidence up to 6.9 per 1000 catheter days. CLABSI has a significant attributable mortality and increases in-hospital length of stay, readmissions, and costs. Chlorhexidine gluconate (CHG), a broad-spectrum biocide, has been shown to effectively reduce infections including CLABSI; however, few trials have utilized CHG for prevention of central ...[more]

PMID: 32099661

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Project description:BackgroundThe objective of this systematic review is to determine the extent and quality of evidence for use of different types of locking fluids to prevent central venous access device complications in adult critical care patients. Specifically, rates of catheter-related bloodstream infection, colonization, and occlusion were considered. All types of devices were included in the review: central venous catheters, peripherally- inserted central catheters and hemodialysis catheters.MethodsEligibility criteria. Papers had to include adult (>18 years old) critical care patients, be experimental trials, conducted in North America and Europe, and published in peer-reviewed journals from 2010 onwards. Information sources. A search of Medline and EMBASE databases was performed. The search is current as of November 28th, 2022. Risk of bias. The Cochrane Risk of Bias 2 and the Risk of Bias In Non-Randomized Studies of Intervention tools were used to assess the risk of bias in included studies.ResultsIncluded studies. A total of 240 paper titles and abstracts underwent review, of these seven studies met the final criteria for quality appraisal. A total of three studies earned a low risk of bias quality appraisal.DiscussionLimitations of evidence. Due to heterogeneity of types of locking fluids investigated and small number of studies identified, meta-analysis of results was not possible. Interpretation. Out of all fluids investigated, only citrate 46.7% was found to statistically reduce central venous access device complication rates. This systematic review has also identified a gap in the literature regarding studies of locking fluids that are adequately powered in this patient population.Future directionsFuture research should include investigations and use of novel locking fluids with more effective properties against complications. It is imperative that future studies are adequately powered, randomized controlled trials in this patient population to facilitate optimal evidence-based care.

Project description:Chlorhexidine gluconate (CHG)-containing dressings are recommended to prevent central line associated bloodstream infections (CLABSIs) and other catheter-related infections. This study compared the effect of 2 CHG dressings on CLABSI, cost of care, and contact dermatitis. A retrospective analysis was conducted using the Premier Healthcare Database of hospitalized patients (n = 53 149) with central venous catheters (CVCs) and receiving either a transparent CHG gel dressing (n = 14 488) or an opaque CHG sponge dressing (n = 38 661) between January 2019 and September 2020. Two cohorts (n = 14 488 each), CHG-Gel and CHG-Sponge, were matched 1:1 using a propensity score method on 33 patient and facility characteristics. CLABSI and contact dermatitis rates, hospital length of stay (LOS), and hospitalization costs were compared using mixed-effect multiple regression. This approach effectively controlled for random clustering effects across hospitals and patients' Diagnosis-Related Group (DRG) classifications. CHG gel dressings were associated with a 41% decrease in CLABSI rates (P = .0008) compared to CHG sponge dressings (0.35%vs 0.60%). A 0.4-day shorter LOS (9.53vs 9.90 days, P = .0001) and a cost saving of $3576 per hospital stay ($40 197 vs $43 774, P = .0179) was observed with CHG gel dressing use. There was no statistically significant difference in contact dermatitis rates (P = .7854) between the CHG-Gel and CHG-Sponge cohorts. The findings of this study suggest that the use of CHG gel dressings may be more effective in reducing the risk of CLABSIs and associated clinical costs compared to CHG sponge dressings in hospitalized patients. Moreover, there appears to be no significant discrepancy in contact dermatitis rates between CHG gel and CHG sponge dressings. Healthcare providers may consider using CHG gel dressings as a standard practice for patients with CVCs to reduce the risk of infections and improve patient outcomes.

Project description:BackgroundCentral line-associated bloodstream infections (CLABSIs) result in approximately 28,000 deaths and approximately $2.3 billion in added costs to the U.S. healthcare system each year, and yet, many of these infections are preventable. At two large health systems in the southeast United States, CLABSIs continue to be an area of opportunity. Despite strong evidence for interventions to prevent CLABSI and reduce associated patient harm, such as use of chlorhexidine gluconate (CHG) bathing, the adoption of these interventions in practice is poor. The primary objective of this study was to assess the effect of a tailored, multifaceted implementation program on nursing staff's compliance with the CHG bathing process and electronic health record (EHR) documentation in critically ill patients. The secondary objectives were to examine the (1) moderating effect of unit characteristics and cultural context, (2) intervention effect on nursing staff's knowledge and perceptions of CHG bathing, and (3) intervention effect on CLABSI rates.MethodsA stepped wedged cluster-randomized design was used with units clustered into 4 sequences; each sequence consecutively began the intervention over the course of 4 months. The Grol and Wensing Model of Implementation helped guide selection of the implementation strategies, which included educational outreach visits and audit and feedback. Compliance with the appropriate CHG bathing process and daily CHG bathing documentation were assessed. Outcomes were assessed 12 months after the intervention to assess for sustainability.ResultsAmong the 14 clinical units participating, 8 were in a university hospital setting and 6 were in community hospital settings. CHG bathing process compliance and nursing staff's knowledge and perceptions of CHG bathing significantly improved after the intervention (p = .009, p = .002, and p = .01, respectively). CHG bathing documentation compliance and CLABSI rates did not significantly improve; however, there was a clinically significant 27.4% decrease in CLABSI rates.ConclusionsUsing educational outreach visits and audit and feedback implementation strategies can improve adoption of evidence-based CHG bathing practices.Trial registrationClinicalTrials.gov, NCT03898115 , Registered 28 March 2019.

Dataset Information

Chlorhexidine locking device for central line infection prevention in ICU patients: protocol for an open-label pilot and feasibility randomized controlled trial.

Publications

Chlorhexidine locking device for central line infection prevention in ICU patients: protocol for an open-label pilot and feasibility randomized controlled trial.

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