A Randomized, Controlled Trial of Catheter-Related Infectious Event Rates Using Antibiotic-Impregnated Catheters Versus Conventional Catheters in Pediatric Cardiovascular Surgery Patients

Cox, Elaine G.; Knoderer, Chad A.; Jennings, Aimee; Brown, John W.; Rodefeld, Mark D.; Walker, Scott G.; Turrentine, Mark W.

doi:10.1093/jpids/pis066

Cited by 14 publications

(27 citation statements)

References 10 publications

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“…A smaller trial 27 compared catheter-related bloodstream infection in children randomly assigned to minocycline and rifampicinimpregnated CVC or standard CVC and found no difference in the rate of catheter-acquired bloodstream infection, but detected few infection events (three in each group; appendix). 27 Third, reductions in infection rates in neonatal units associated with improved catheter asepsis practices and shorter duration of PICC use might have narrowed the potential for further benefits from antimicrobial impregnation. 28 PICCs also might not be an independent risk factor for infection in sick preterm babies because of their high susceptibility to infection from multiple sources, due to numerous invasive procedures and devices, gut permeability, and immune immaturity.…”

Section: Discussionmentioning

confidence: 99%

Antimicrobial-impregnated central venous catheters for prevention of neonatal bloodstream infection (PREVAIL): an open-label, parallel-group, pragmatic, randomised controlled trial

Gilbert

Brown

Rainford

et al. 2019

The Lancet Child & Adolescent Health

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Background Bloodstream infection is associated with high mortality and serious morbidity in preterm babies. Evidence from clinical trials shows that antimicrobial-impregnated central venous catheters (CVCs) reduce catheterrelated bloodstream infection in adults and children receiving intensive care, but there is a paucity of similar evidence for babies receiving neonatal intensive care. Methods This open-label, parallel-group, pragmatic, randomised controlled trial was done in 18 neonatal intensive care units in England. Newborn babies who needed a peripherally inserted CVC (PICC) were allocated randomly (1:1) to receive either a PICC impregnated with miconazole and rifampicin or a standard (non-antimicrobial-impregnated) PICC. Random allocation was done with a web-based program, which was centrally controlled to ensure allocation concealment. Randomisation sequences were computer-generated in random blocks of two and four, and stratified by site. Masking of clinicians to PICC allocation was impractical because rifampicin caused brown staining of the antimicrobial-impregnated PICC. However, participant inclusion in analyses and occurrence of outcome events were determined following an analysis plan that was specified before individuals saw the unblinded data. The primary outcome was the time from random allocation to first microbiologically confirmed bloodstream or cerebrospinal fluid (CSF) infection between 24 h after randomisation and 48 h after PICC removal or death. We analysed outcome data according to the intention-to-treat principle. We excluded babies for whom a PICC was not inserted from safety analyses, as these analyses were done with groups defined by the PICC used. This trial is registered with ISRCTN, number 81931394. Findings Between Aug 12, 2015, and Jan 11, 2017, we randomly assigned 861 babies (754 [88%] born before 32 weeks of gestation) to receive an antimicrobial-impregnated PICC (430 babies) or standard PICC (431 babies). The median time to PICC removal was 8•20 days (IQR 4•77-12•13) in the antimicrobial-impregnated PICC group versus 7•86 days (5•00-12•53) days in the standard PICC group (hazard ratio [HR] 1•03, 95% CI 0•89-1•18, p=0•73), with 46 (11%) of 430 babies versus 44 (10%) of 431 babies having a microbiologically confirmed bloodstream or CSF infection. The time from random allocation to first bloodstream or CSF infection was similar between the two groups (HR 1•11, 95% CI 0•73-1•67, p=0•63). Secondary outcomes relating to infection, rifampicin resistance in positive blood or CSF cultures, mortality, clinical outcomes at neonatal unit discharge, and time to PICC removal were similar between the two groups, although rifampicin resistance in positive cultures of PICC tips was higher in the antimicrobial-impregnated PICC group (relative risk 3•51, 95% CI 1•16-10•57, p=0•018). 60 adverse events were reported from 49 (13%) patients in the antimicrobial-impregnated PICC group and 50 events from 45 (10%) babies in the standard PICC group. Interpretation We found no evidence of benefit or ha...

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Section: Discussionmentioning

confidence: 99%

Antimicrobial-impregnated central venous catheters for prevention of neonatal bloodstream infection (PREVAIL): an open-label, parallel-group, pragmatic, randomised controlled trial

Gilbert

Brown

Rainford

et al. 2019

The Lancet Child & Adolescent Health

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“…However, these engineering advancements have not yielded clear clinical benefit. 1, 2 Although advancements in surgical insertion procedures and processes have reduced their incidence, CLABSIs remain one of the leading causes of bloodstream infections in the US with over 250,000 infected catheters annually. 3, 4 Importantly, the Centers for Disease Control estimate an attributable mortality of 12%-25% for each infection.…”

Section: Introductionmentioning

confidence: 99%

Hemodialysis Catheter Heat Transfer for Biofilm Prevention and Treatment

Richardson¹,

Sturtevant²,

Heung³

et al. 2016

ASAIO Journal

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Central line-associated bloodstream infections (CLABSIs) are not easily treated and many catheters (e.g., hemodialysis catheters) are not easily replaced. Biofilms (the source of infection) on catheter surfaces are notoriously difficult to eradicate. We have recently demonstrated that modest elevations of temperature lead to increased staphylococcal susceptibility to vancomycin and significantly soften the biofilm matrix. In this study, using a combination of microbiological, computational, and experimental studies, we demonstrate the efficacy, feasibility, and safety of using heat as an adjuvant treatment for infected hemodialysis catheters. Specifically, we show that treating with heat in the presence of antibiotics led to additive killing of Staphylococcus epidermidis with similar trends seen for Staphylococcus aureus and Klebsiella pneumoniae. The magnitude of temperature elevation required is relatively modest (45-50°C) and similar to that used as an adjuvant to traditional cancer therapy. Using a custom-designed benchtop model of a hemodialysis catheter positioned with tip in the human vena cava as well as computational fluid dynamic simulations we demonstrate that these temperature elevations are likely achievable in situ with minimal increased in overall blood temperature.

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“…The study by Cox [7] included patients less than 18 years of age who underwent cardiovascular surgery from October 2006 to March 2010 at Riley Hospital for Children in Indianapolis. These patients required placement of a double lumen central venous catheter, either minocycline/rifampin impregnated or the conventional one, under full sterile conditions in an operating room.…”

Section: Results Of the Searchmentioning

confidence: 99%

“…Most studies that support its recommendation are trials or reviews primarily of adults [6]. Because of this scarcity of trials in children, efficacy and safety concerns remain an issue [7].…”

Section: Why It Is Important To Do This Reviewmentioning

confidence: 99%

Antibiotic-Impregnated Central Venous Catheters for the Prevention of Catheter-Related Bloodstream Infection in Children: A Meta-Analysis

Espino¹,

Dator²,

Gonzales³

2017

Microbiol Infect Dis

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Background: Use of central venous catheters (CVCs) ensure stable access in critically ill patients but is associated with increased infection rates. CVCs with antimicrobials has been recommended for infection reduction in adults. A review of antibiotic-impregnated CVCs' usefulness in children is needed. Objectives: To determine the effectiveness of antibiotic-impregnated CVCs in reducing infection in children Search Methods: Extensive search of MEDLINE, Cochrane Database of Systematic Reviews and Cochrane Register of Controlled Trials, Clinicaltrials.gov, Google scholar was done for trials published until June 2016. Reference lists from retrieved journals were checked for relevant articles. Selection Criteria: RCTs evaluating antibiotic-impregnated compared with standard CVCs for reducing infection in children. Data Collection and Analysis: Two authors assessed trial quality and extracted data. Statistical analysis was done using Review Manager with fixed or random effects model. Outcomes: bloodstream infection, hypersensitivity, thrombosis, mortality, site infection, length of ICU and hospital stay. Dichotomous data were presented as risk ratios (RR), continuous data as mean differences with 95% confidence intervals (CIs). Main Results: Two low quality trials (n=1773) were analyzed showing nonsignficant reduction of bloodstream infection in the antibiotic-impregnated group compared to standard catheters (RR 0.49; 95% CI 0.23-1.02,I2=0%) with no increased risk of thrombosis (RR 1.04 95% CI 0.84-1.28,I2=0%). No statistical difference was seen in the duration of ICU and hospital stay. Authors' Conclusions: There is no evidence that antibiotic-impregnated CVCs reduced bacteremia in children, increased the risk for thrombosis, or improved ICU and hospital stay. More RCTs are needed to determine benefits of antibiotic-impregnated CVCs.

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A Randomized, Controlled Trial of Catheter-Related Infectious Event Rates Using Antibiotic-Impregnated Catheters Versus Conventional Catheters in Pediatric Cardiovascular Surgery Patients

Cited by 14 publications

References 10 publications

Antimicrobial-impregnated central venous catheters for prevention of neonatal bloodstream infection (PREVAIL): an open-label, parallel-group, pragmatic, randomised controlled trial

Antimicrobial-impregnated central venous catheters for prevention of neonatal bloodstream infection (PREVAIL): an open-label, parallel-group, pragmatic, randomised controlled trial

Hemodialysis Catheter Heat Transfer for Biofilm Prevention and Treatment

Antibiotic-Impregnated Central Venous Catheters for the Prevention of Catheter-Related Bloodstream Infection in Children: A Meta-Analysis

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