Dressings and securement devices to prevent complications for peripheral arterial catheters.

BACKGROUND: Peripheral arterial catheters (ACs) are used in anaesthesia and intensive care settings for blood sampling and monitoring. Despite their importance, ACs often fail, requiring reinsertion. Dressings and securement devices maintain AC function and prevent complications such as infection. OBJECTIVES: To evaluate the effectiveness of peripheral AC dressing and securement devices to prevent failure and complications in hospitalised people. SEARCH METHODS: We searched the Cochrane Wounds Specialised Register, CENTRAL, MEDLINE, Embase, and CINAHL Plus up to 16 May 2023. We also searched ClinicalTrials.gov and the World Health Organization International Clinical Trials Registry Platform up to 16 May 2023. SELECTION CRITERIA: We included randomised controlled trials (RCTs) comparing different dressing and securement devices for the stabilisation of ACs in hospitalised people. DATA COLLECTION AND ANALYSIS: Two review authors independently selected trials for inclusion, extracted data, and assessed risk of bias using Cochrane's RoB 1 tool. We resolved disagreements by discussion, or by consulting a third review author when necessary. We assessed the certainty of evidence using GRADE. MAIN RESULTS: We included five RCTs with 1228 participants and 1228 ACs. All included studies had high risk of bias in one or more domains. We present the following four comparisons, with the remaining comparisons reported in the main review. Standard polyurethane (SPU) plus tissue adhesive (TA) compared with SPU: we are very uncertain whether use of SPU plus TA impacts rates of AC failure (risk ratio (RR) 0.44, 95% confidence interval (CI) 0.20 to 0.98; I² = 0%; 2 studies, 165 participants; very low-certainty evidence). Neither study (165 participants) reported catheter-related bloodstream infections (CRBSI), thus we are very uncertain whether SPU plus TA impacts on the incidence of CRBSI (very low-certainty evidence). It is very uncertain whether use of SPU plus TA impacts AC dislodgement risk (RR 0.54, 95% CI 0.03 to 9.62; I² = 44%; 2 studies, 165 participants; very low-certainty evidence). We are very uncertain whether use of SPU plus TA impacts AC occlusion rates (RR 1.20, 95% CI 0.37 to 3.91; I² = 3%; 2 studies, 165 participants; very low-certainty evidence). We are very uncertain whether use of SPU plus TA impacts rates of adverse events with few reported events across groups (RR 0.89, 95% CI 0.09 to 8.33; I² = 0%; 2 studies, 165 participants; very low-certainty evidence). Bordered polyurethane (BPU) compared to SPU: we are very uncertain whether use of BPU impacts rates of AC failure (RR 0.67, 95% CI 0.21 to 2.13; 1 study, 60 participants; very low-certainty evidence). BPU may make little or no difference to CRBSI compared to SPU (RR 3.05, 95% CI 0.12 to 74.45; I² = not applicable as 1 study (60 participants) reported 0 events; 2 studies, 572 participants; low-certainty evidence). BPU may make little or no difference to the risk of AC dislodgement compared with SPU (RR 0.75, 95% CI 0.17 to 3.22; I² = 0%; 2 studies, 572 participants; low-certainty evidence). BPU may make little or no difference to occlusion risk compared with SPU (RR 0.80, 95% CI 0.60 to 1.07; I² = 0%; 2 studies, 572 participants; low-certainty evidence). It is very uncertain whether BPU impacts on the risk of adverse events compared with SPU (RR 0.33, 95% CI 0.01 to 7.87; 1 study, 60 participants; very low-certainty evidence). SPU plus sutureless securement devices (SSD) compared to SPU: we are very uncertain whether SPU plus SSD impacts risk of AC failure compared with SPU (RR 0.78, 95% CI 0.40 to 1.52; I² = 0%; 2 studies, 157 participants; very low-certainty evidence). We are very uncertain if SPU plus SSD impacts CRBSI incidence rate with no events in both groups (2 studies, 157 participants; very low-certainty evidence). It is very uncertain whether SPU plus SSD impacts risk of dislodgement (RR 0.14, 95% CI 0.01 to 2.57; I² = not applicable as 1 study (96 participants) reported 0 events; 2 studies, 157 participants; very low-certainty evidence). It is very uncertain whether SPU plus SSD impacts risk of AC occlusion (RR 1.94, 95% CI 0.50 to 7.48; I² = 38%; 2 studies, 157 participants; very low-certainty evidence). We are very uncertain whether SPU plus SSD impacts on the risk of adverse events (RR 1.94, 95% CI 0.19 to 20.24; I² = not applicable as 1 study (96 participants) reported 0 events; 2 studies, 157 participants; very low-certainty evidence). Integrated securement dressings compared to SPU: integrated securement dressings may result in little or no difference in risk of AC failure compared with SPU (RR 1.96, 95% CI 0.80 to 4.84; 1 study, 105 participants; low-certainty evidence); may result in little or no difference in CRBSI incidence with no events reported (1 study, 105 participants; low-certainty evidence); may result in little or no difference in the risk of dislodgement (RR 0.33, 95% CI 0.04 to 3.04; 1 study, 105 participants; low-certainty evidence), may result in little or no difference in occlusion rates with no events reported (1 study, 105 participants; low-certainty evidence), and may result in little or no difference in the risk of adverse events (RR 0.35, 95% CI 0.01 to 8.45; 1 study, 105 participants; low-certainty evidence). AUTHORS' CONCLUSIONS: There is currently limited rigorous RCT evidence available about the relative clinical effectiveness of AC dressing and securement products. Limitations of current evidence include small sample size, infrequent events, and heterogeneous outcome measurements. We found no clear difference in the incidence of AC failure, CRBSI, or adverse events across AC dressing or securement products including SPU, BPU, SSD, TA, and integrated securement products. The limitations of current evidence means further rigorous RCTs are needed to reduce uncertainty around the use of dressing and securement devices for ACs.

Novel Peripheral Intravenous Catheter Securement for Children and Catheter Failure Reduction: A Randomized Clinical Trial.

Importance: Peripheral intravenous catheters (PIVCs) facilitate essential treatment. Failure of these essential devices is frequent and new securement strategies may reduce failure and improve patient outcomes. Objective: To evaluate clinical effectiveness of novel PIVC securement technologies for children to reduce catheter failure. Design, Setting, and Participants: A 3-arm, parallel group, superiority randomized clinical trial was conducted at 2 regional Australian hospitals from February 5, 2020, to January 14, 2022. Children aged 6 months to 8 years who were anticipated to require admission with a PIVC for at least 24 hours of in hospital treatment were eligible. Data were analyzed from May 25, 2022, to February 20, 2024. Interventions: Participants were randomly allocated in a 1:1:1 ratio to standard care, bordered polyurethane (Tegaderm [3M]), integrated securement dressing (SorbaView SHIELD [Medline]), and integrated securement dressing with tissue adhesive (Secureport IV). One catheter was studied per patient. Main Outcomes and Measures: Primary outcome was PIVC failure, defined as premature cessation of PIVC function for any reason prior to completion of planned treatment. Secondary outcomes were PIVC complications (any time dislodgement, occlusion, infiltration, partial dislodgement, extravasation, device leaking, phlebitis, pain), PIVC longevity, intervention acceptability (clinicians, participants, caregivers; 0-10 scale), and pain on removal (participants and caregivers; 0-10 scale relevant to age), adverse events, and health care costs. Results: A total of 383 patients (51% female; median age 36 [25th-75th percentiles, 22-72] months) were randomized 134 to standard care, 118 to integrated securement dressing, and 131 to integrated securement dressing with tissue adhesive. PIVC failure was lowest in integrated securement dressing with tissue adhesive (15 [12%]; adjusted hazard ratio [aHR], 0.47; 95% CI, 0.26-0.84) compared with integrated securement dressing (24 [21%]; aHR, 0.78; 95% CI, 0.47-1.28) and standard care (43 [34%]). Direct costs were significantly lower for integrated securement dressing with tissue adhesive (median, Australian dollars [A$], 312 [A$1 is equal to $0.65 US dollars]; IQR, A$302-A$380) and integrated securement dressing (median, A$303; IQR, A$294-A$465) compared with standard care (median, A$341; IQR, A$297-A$592; P ≤ .002) when considering the economic burden related to failure of devices. PIVC longevity and intervention acceptability were similar across all groups. Conclusions and Relevance: In this study, PIVCs secured with integrated securement dressings and tissue adhesive, in comparison with standard care, bordered polyurethane dressings, were associated with significantly reduced PIVC failure, for children admitted to hospital via the emergency department. Further research should focus on implementation in inpatient units where prolonged dwell and reliable intravenous access is most needed. Trial Registration: Australian New Zealand Clinical Trials Registry Identifier: ACTRN12619001026112.

Central Venous Access Device-Associated Skin Complications in Adults with Cancer: A Prospective Observational Study.

OBJECTIVES: To identify the prevalence and type of central venous access device-associated skin complications for adult cancer patients, describe central venous access device management practices, and identify clinical and demographic characteristics associated with risk of central venous access device-associated skin complications. METHODS: A prospective cohort study of 369 patients (626 central venous access devices; 7,682 catheter days) was undertaken between March 2017 and March 2018 across two cancer care in-patient units in a large teaching hospital. RESULTS: Twenty-seven percent (n = 168) of participants had a central venous access device-associated skin complication. In the final multivariable analysis, significant (P < .05) risk factors for skin complications were cutaneous graft versus host disease (2.1 times greater risk) and female sex (1.4 times greater risk), whereas totally implanted vascular access device reduced risk for skin complications by two-thirds (incidence risk ratio 0.37). CONCLUSION: Central venous access device-associated skin complications are a significant, potentially avoidable injury, requiring cancer nurses to be aware of high-risk groups and use evidence-based preventative and treatment strategies. IMPLICATIONS FOR PRACTICE: This study has confirmed how common these potentially preventable injuries are. Therefore, the prevalence of these complications could be reduced by focusing on improvements in skin assessment, reductions in central venous access device dressing variation and improving clinician knowledge of this injury.

Health-related quality of life and experience measures, to assess patients' experiences of peripheral intravenous catheters: a secondary data analysis.

BACKGROUND: Peripheral intravenous catheters (PIVCs) are essential for successful administration of intravenous treatments. However, insertion failure and PIVC complications are common and negatively impact patients' health-outcomes and experiences. We aimed to assess whether generic (not condition-specific) quality of life and experience measures were suitable for assessing outcomes and experiences of patients with PIVCs. METHODS: We undertook a secondary analysis of data collected on three existing instruments within a large randomised controlled trial, conducted at two adult tertiary hospitals in Queensland, Australia. Instruments included the EuroQol Five Dimension - Five Level (EQ5D-5L), the Functional Assessment of Chronic Illness Therapy - Treatment Satisfaction - General measure (FACIT-TS-G, eight items), and the Australian Hospital Patient Experience Question Set (AHPEQS, 12 items). Responses were compared against two clinical PIVC outcomes of interest: all-cause failure and multiple insertion attempts. Classic descriptives were reported for ceiling and floor effects. Regression analyses examined validity (discrimination). Standardised response mean and effect size (ES) assessed responsiveness (EQ5D-5L, only). RESULTS: In total, 685 participants completed the EQ5D-5L at insertion and 526 at removal. The FACIT-TS-G was completed by 264 and the AHPEQS by 262 participants. Two FACIT-TS-G items and one AHPEQS item demonstrated ceiling effect. Instruments overall demonstrated poor discrimination, however, all-cause PIVC failure was significantly associated with several individual items in the instruments (e.g., AHPEQS, 'unexpected physical and emotional harm'). EQ5D-5L demonstrated trivial (ES < 0.20) responsiveness. CONCLUSIONS: Initial investigation of an existing health-related quality of life measure (EQ5D-5L) and two patient-reported experience measures (FACIT-TS-G; AHPEQS) suggest they are inadequate (as a summary measure) to assess outcomes and experiences for patients with PIVCs. Reliable instruments are urgently needed to inform quality improvement and benchmark standards of care.

Peripheral intravenous catheter infection and failure: A systematic review and meta-analysis.

BACKGROUND: Peripheral intravenous catheters are the most frequently used invasive device in nursing practice, yet are commonly associated with complications. We performed a systematic review to determine the prevalence of peripheral intravenous catheter infection and all-cause failure. METHODS: The Cochrane Library, PubMed, CINAHL, and EMBASE were searched for observational studies and randomised controlled trials that reported peripheral intravenous catheter related infections or failure. The review was limited to English language and articles published from the year 2000. Pooled estimates were calculated with random-effects models. Meta-analysis of observation studies in epidemiology guidelines and the Cochrane process for randomised controlled trials were used to guide the review. Prospero registration number: CRD42022349956. FINDINGS: Our search retrieved 34,725 studies. Of these, 41 observational studies and 28 randomised controlled trials (478,586 peripheral intravenous catheters) met inclusion criteria. The pooled proportion of catheter-associated bloodstream infections was 0.028 % (95 % confidence interval (CI): 0.009-0.081; 38 studies), or 4.40 catheter-associated bloodstream infections per 100,000 catheter-days (20 studies, 95 % CI: 3.47-5.58). Local infection was reported in 0.150 % of peripheral intravenous catheters (95 % CI: 0.047-0.479, 30 studies) with an incidence rate of 65.1 per 100,000 catheter-days (16 studies; 95 % CI: 49.2-86.2). All cause peripheral intravenous catheter failure before treatment completion occurred in 36.4 % of catheters (95 % CI: 31.7-41.3, 53 studies) with an overall incidence rate of 4.42 per 100 catheter days (78,891 catheter days; 19 studies; 95 % CI: 4.27-4.57). INTERPRETATION: Peripheral intravenous catheter failure is a significant worldwide problem, affecting one in three catheters. Per peripheral intravenous catheter, infection occurrence was low, however, with over two billion catheters used globally each year, the absolute number of infections and associated burden remains high. Substantial and systemwide efforts are needed to address peripheral intravenous catheter infection and failure and the sequelae of treatment disruption, increased health costs and poor patient outcomes.

Multi-center, pragmatic, cluster-randomized, controlled trial of standardized peritoneal dialysis (PD) training versus usual care on PD-related infections (the TEACH-PD trial): trial protocol.

BACKGROUND: Peritoneal dialysis (PD)-related infections, such as peritonitis, exit site, and tunnel infections, substantially impair the sustainability of PD. Accordingly, PD-related infection is the top-priority research outcome for patients and caregivers. While PD nurse trainers teach patients to perform their own PD, PD training curricula are not standardized or informed by an evidentiary base and may offer a potential approach to prevent PD infections. The Targeted Education ApproaCH to improve Peritoneal Dialysis outcomes (TEACH-PD) trial evaluates whether a standardized training curriculum for PD nurse trainers and incident PD patients based on the International Society for Peritoneal Dialysis (ISPD) guidelines reduces PD-related infections compared to usual training practices. METHODS: The TEACH-PD trial is a registry-based, pragmatic, open-label, multi-center, binational, cluster-randomized controlled trial. TEACH-PD will recruit adults aged 18 years or older who have not previously undergone PD training at 42 PD treatment units (clusters) in Australia and New Zealand (ANZ) between July 2019 and June 2023. Clusters will be randomized 1:1 to standardized TEACH-PD training curriculum or usual training practice. The primary trial outcome is the time to the first occurrence of any PD-related infection (exit site infection, tunnel infection, or peritonitis). The secondary trial outcomes are the individual components of the primary outcome, infection-associated catheter removal, transfer to hemodialysis (greater than 30 days and 180 days), quality of life, hospitalization, all-cause death, a composite of transfer to hemodialysis or all-cause death, and cost-effectiveness. Participants are followed for a minimum of 12 months with a targeted average follow-up period of 2 years. Participant and outcome data are collected from the ANZ Dialysis and Transplant Registry (ANZDATA) and the New Zealand Peritoneal Dialysis (NZPD) Registry. This protocol follows the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) guidelines. DISCUSSION: TEACH-PD is a registry-based, cluster-randomized pragmatic trial that aims to provide high-certainty evidence about whether an ISPD guideline-informed standardized PD training curriculum for PD nurse trainers and adult patients prevents PD-related infections. TRIAL REGISTRATION: ClinicalTrials.gov NCT03816111. Registered on 24 January 2019.

The impact of a structured assessment and decision tool (I-DECIDED®) on improving care of peripheral intravenous catheters: A multicenter, interrupted time-series study.

BACKGROUND: Peripheral intravenous catheters are the most widely used invasive device in hospitals but have serious risks. OBJECTIVE: To determine if a structured assessment and decision tool (I-DECIDED®) improves daily peripheral intravenous catheter assessment and care decisions. DESIGN: Prospective, interrupted time-series study. SETTINGS: Seven adult inpatient wards in three Australian hospitals. PARTICIPANTS: 825 adults with 867 peripheral intravenous catheters. METHODS: Between August 2017 and December 2018, peripheral intravenous catheter assessments and chart audits were undertaken with informed patient consent. Following a 4-month pre-intervention period (with 2-weekly measures), the I-DECIDED® tool was implemented over 3 months (no data collection) using multiple strategies (stakeholder meetings, vascular access device form, education sessions, ward champions, lanyard cards, and posters), followed by a 4-month post-intervention period (with 2-weekly measures). Primary outcomes were device utilization (number of peripheral intravenous catheters per total number of patients screened); idle/unused catheters; insertion site complications, substandard dressing quality; and primary bloodstream infections. RESULTS: Of 2055 patients screened, 1175 (57.2%) had a peripheral intravenous catheter, and 825 patients (867 catheters) consented and were included in the final analysis. Device utilization increased from 42.0% of catheters at baseline to 49.6% post-intervention (absolute risk difference [ARD] 7.5%, 95% confidence interval [CI] 4.8, 10.3; relative risk [RR] 1.18, 95% CI 1.11, 1.25; p < 0.001). The proportion of idle catheters reduced from 12.7% to 8.3% (ARD -4.4%, 95% CI -8.5, -0.3; RR 0.66, 95% CI 0.44, 0.97; p = 0.035). Peripheral intravenous catheter complications reduced from 16.1% to 10.9% (ARD -5.2%, 95% CI -9.7, -0.6; RR 0.68, 95% CI 0.48, 0.96; p = 0.026). Substandard dressings reduced from 24.6% to 19.5% (ARD -5.2%, 95% CI -10.7, 0.4; RR 0.79, 95% CI 0.61, 1.02; p = 0.067). Only one primary bloodstream infection occurred (post-intervention). CONCLUSIONS: Implementation of a comprehensive device assessment and decision tool (I-DECIDED®) reduced idle catheters and catheter complications, despite higher device utilization. Dressing quality improved but was not statistically significant. Further implementation of the tool could improve hospital safety for patients with an intravenous catheter. ANZCTR TRIAL REGISTRATION: ACTRN12617000067370. Date of registration 13 January 2017. Date of first data collection 3rd August 2017. TWEETABLE ABSTRACT: #IDECIDEDassessment reduces prevalence of idle peripheral catheters and device complications.

Controlling peripheral intravenous catheter failure by needleless connector design: A pilot randomised controlled trial.

AIM: To test the feasibility of a study protocol that compared the efficacy of neutral- and negative-pressure needleless connectors (NCs). DESIGN: A single-centre, parallel-group, pilot randomised control trial. METHODS: Our study compared neutral-(intervention) and negative-pressure (control) NCs among adult patients in an Australian hospital. The primary feasibility outcome was measured against predetermined criteria (e.g. eligibility, attrition). The primary efficacy outcome was all-cause peripheral intravenous catheter failure, analysed as time-to-event data. RESULTS: In total, 201 (100 control; 101 intervention) participants were enrolled between March 2020 and September 2020. All feasibility criteria were met except eligibility, which was lower (78%) than the 90% criterion. All-cause peripheral intravenous catheter failure was significantly higher in the intervention group (39%) compared to control (19%). CONCLUSION: With minor modifications to participant screening for eligibility, this randomised control trial is feasible for a large multicentre randomised control trial. The neutral NC was associated with an increased risk of peripheral intravenous catheter failure. IMPLICATIONS FOR THE PROFESSION AND/OR PATIENT CARE: There are several NC designs available, often identified by their mechanism of pressure (positive, negative and neutral). However, NCs can contribute to peripheral intravenous catheter failure. This is the first randomised controlled trial to compare neutral and negative NC designs. Negative pressure NCs had lower PIVC failure compared to neutral NCs, however the results might not be generalisable to other brands or treatment settings. Further high-quality research is needed to explore NC design. REPORTING METHOD: Study methods and results reported in adherence to the CONSORT Statement. PATIENT OR PUBLIC CONTRIBUTION: No patient or public contribution.

Association between parenteral nutrition-containing intravenous lipid emulsion and bloodstream infections in patients with single-lumen central venous access: A secondary analysis of a randomized trial.

BACKGROUND: Distinguishing primary bloodstream infections (BSIs) related to central venous access devices (CVADs) from those that occur through other mechanisms, such as a damaged mucosal barrier, is difficult. METHODS: Secondary analysis was conducted on data from patients with CVADs that were collected for a large, randomized trial. Patients were divided into two groups: those who received parenteral nutrition (PN)-containing intravenous lipid emulsion (ILE) and those who did not have PN-containing ILE. This study investigated the influence of PN-containing ILE (ILE PN) on primary BSIs in patients with a CVAD. RESULTS: Of the 807 patients, 180 (22%) received ILE PN. Most (627/807; 73%) were recruited from the hematology and hematopoietic stem cell transplant unit, followed by surgical (90/807; 11%), trauma and burns (61/807; 8%), medical (44/807; 5%), and oncology (23/807; 3%). When primary BSI was differentiated as a central line-associated BSI (CLABSI) or mucosal barrier injury laboratory-confirmed BSI (MBI-LCBI), the incidence of CLABSI was similar in the ILE PN and non-ILE PN groups (15/180 [8%] vs 57/627 [9%]; P = 0.88) and the incidence of MBI-LCBI was significantly different between groups (31/180 [17%] ILE PN vs 41/627 [7%] non-ILE PN; P < 0.01). CONCLUSION: Our data indicate that twice as many primary BSIs in ILE PN patients are due to MBIs than CVADs. It is important to consider the MBI-LCBI classification, as some CLABSI prevention efforts aimed at CVADs for the ILE PN population may be better directed to gastrointestinal tract protection interventions.

Patient blood management in critically ill children undergoing cardiac surgery: A cohort study.

OBJECTIVE: The objective of this study was to audit current patient blood management practice in children throughout cardiac surgery and paediatric intensive care unit (PICU) admission. DESIGN: This was a prospective observational cohort study. SETTING: This was a single-centre study in the cardiac operating room (OR) and PICU in a major tertiary children's hospital in Australia. PATIENTS: Children undergoing corrective cardiac surgery and requiring admission to PICU for postoperative recovery were included in the study. MEASUREMENTS AND MAIN RESULTS: Fifty-six patients and 1779 blood sampling episodes were audited over a 7-month period. The median age was 9 months (interquartile range [IQR] = 1-102), with the majority (n = 30 [54%]) younger than 12 months. The median number of blood sampling episodes per patient per day was 6.6 (IQR = 5.8-8.0) in total, with a median of 5.0 (IQR = 4.0-7.5) episodes in the OR and 5.0 (IQR = 3.4-6.2) episodes per day throughout PICU admission. The most common reason for blood tests across both OR and PICU settings was arterial blood gas analysis (total median = 86%, IQR = 79-96). The overall median blood sampling volume per kg of bodyweight, patient, and day was 0.63 mL (IQR = 0.20-1.14) in total. Median blood loss for each patient was 3.5 mL/kg per patient per day (IQR = 1.7-5.6) with negligible amounts in the OR and a median of 3.6 mL/kg (IQR = 1.7-5.7) in the PICU. The median Cell Saver® transfusion volume was 9.9 mL/kg per patient per day (IQR = 4.0-19.1) in the OR. The overall median volume of other infusion products (albumin 4%, albumin 20%, packed red blood cells) received by each patient was 20.1 mL/kg (IQR = 10.7-36.4) per day. Sampling events and blood loss were positively associated with PICU stay. CONCLUSIONS: Patient blood management practices observed in this study largely conform to National Blood Authority guidelines. Further implementation projects and research are needed to accelerate implementation of known effective blood conservation strategies within paediatric critical care environments.

Integrated versus nonintegrated peripheral intravenous catheter in hospitalized adults (OPTIMUM): A randomized controlled trial.

BACKGROUND: One-third of peripheral intravenous catheters (PIVCs) fail from inflammatory or infectious complications, causing substantial treatment interruption and replacement procedures. OBJECTIVES: We aimed to compare complications between integrated PIVCs (inbuilt extension sets, wings, and flattened bases) and traditional nonintegrated PIVCs. DESIGNS, SETTINGS AND PARTICIPANTS: A centrally randomized, controlled, superiority trial (with allocation concealment until study entry) was conducted in three Australian hospitals. Medical-surgical patients (one PIVC each) requiring intravenous therapy for >24 h were studied. MAIN OUTCOME MEASURES: The primary outcome was device failure (composite: occlusion, infiltration, phlebitis, dislodgement, local, or bloodstream infection). Infection endpoints were assessor-masked. The secondary outcomes were: failure type, first-time insertion success, tip colonization, insertion pain, dwell time, mortality, costs, health-related quality of life, clinician, and patient satisfaction. RESULTS: Out of 1759 patients randomized (integrated PIVC, n = 881; nonintegrated PIVC, n = 878), 1710 (97%) received a PIVC and were in the modified intention-to-treat analysis (2269 PIVC-days integrated; 2073 PIVC-days nonintegrated). Device failure incidence was 35% (145 per 1000 device-days) nonintegrated, and 33% (124 per 1000 device-days) integrated PIVCs. INTERVENTION: Integrated PIVCs had a significantly lower failure risk (adjusted [sex, infection, setting, site, gauge] hazard ratio [HR]: 0.82 [95% confidence interval, CI: 0.69-0.96], p = .015). The per-protocol analysis was consistent (adjusted HR: 0.80 [95% CI: 0.68-0.95], p = .010). Integrated PIVCs had significantly longer dwell (top quartile ≥ 95 vs. ≥84 h). Mean per-patient costs were not statistically different. CONCLUSIONS: PIVC failure is common and complex. Significant risk factors include sex, infection at baseline, care setting, insertion site, catheter gauge, and catheter type. Integrated PIVCs can significantly reduce the burden of PIVC failure on patients and the health system.

Epidemiology of Norovirus in the First 2 Years of Life in an Australian Community-based Birth Cohort.

BACKGROUND: Noroviruses are a leading cause of acute gastroenteritis across all age groups in Australia. We explored the epidemiology of symptomatic and asymptomatic norovirus infection and assessed risk factors and the related healthcare burden in Australian children during their first 2 years of life. METHODS: Participants in the Observational Research in Childhood Infectious Diseases birth cohort provided weekly stool swabs, daily gastrointestinal symptoms (vomiting and loose stools) observations and healthcare data. Swabs were batch-tested for norovirus genogroups (GI and GII) using real-time polymerase chain reaction assays. RESULTS: Overall, 158 children returned 11,124 swabs. There were 221 infection episodes, of which 183 (82.8%) were GII. The incidence rate was 0.90 infections per child-year [95% confidence interval (CI): 0.74-1.09]. The symptomatic infection incidence rate was 0.39 per child-year (95% CI: 0.31-0.48), peaking between ages 6 and 11 months [0.58 (95% CI: 0.41-0.81)]. Incidence increased significantly with age and childcare attendance. Of 209 episodes with symptom diary data, 82 (39.2%) were symptomatic; of these 70 (85.4%) were associated with vomiting and 29 (35.4%) with diarrhea. Forty-one percent of symptomatic episodes required healthcare, including 4 emergency department presentations and 1 hospitalization. Children with initial infections had almost twice the risk of seeking primary healthcare compared to subsequent infections (adjusted risk ratio 1.92; 95% CI: 1.01-3.65). CONCLUSIONS: Norovirus infections, particularly GII, are common in Australian children 6-23 months of age. Estimates of norovirus incidence, including symptomatic infections and healthcare utilization in community settings in young children, are crucial for planning norovirus vaccine programs and determining vaccine effectiveness.

Intravenous antimicrobial administration through peripheral venous catheters - establishing risk profiles from an analysis of 5252 devices.

INTRODUCTION: Peripheral venous catheters (PVCs) are used to administer antimicrobials, but many fail prior to completion of therapy. While some antimicrobials are known to increase the PVC failure rate, risk profiles for many are unclear. OBJECTIVE: To synthesize data from prospective PVC studies conducted between 2013 and 2019 to determine associations between common antimicrobials and PVC failure. METHODS: A secondary analysis was undertaken of seven randomized controlled trials and two prospective cohort studies from three quaternary hospitals (two adult and one paediatric) in Australia between 2013 and 2019. The primary outcome was PVC failure due to vessel injury (occlusion, infiltration or extravasation) or irritation (pain or phlebitis). Associations between antimicrobial use and PVC failure were explored using multi-variable Cox regression. RESULTS: In total, 5252 PVCs (4478 patients) were analysed; vessel injury and irritations occurred in 19% and 11% of all PVCs, respectively. Vessel injury was significantly associated with cefepime hydrochloride [hazard ratio (HR) 2.50; 95% confidence interval (CI) 1.44-4.34], ceftazidime pentahydrate (HR 1.91, 95% CI 1.11-3.31), flucloxacillin sodium (HR 1.84, 95% CI 1.45-2.33), lincomycin hydrochloride (HR 1.67, 95% CI 1.10-2.52) and vancomycin hydrochloride (HR 1.73, 95% CI 1.25-2.40). Irritation was significantly associated with flucloxacillin sodium (HR 2.58, 95% CI 1.96-3.40). CONCLUSIONS: This study identified several antimicrobials associated with increased PVC failure, including some that were already known to be associated and some that had not been identified previously. Research is needed urgently to determine superior modes of delivery (e.g. dilution, infusion time, device type) that may prevent PVC failure.

Potentially Pathogenic Organisms in Stools and Their Association With Acute Diarrheal Illness in Children Aged <2 Years.

BACKGROUND: Acute diarrheal illness (ADI) causes a substantial disease burden in high-income countries. We investigated associations between potentially pathogenic organisms in stools and ADI by polymerase chain reaction (PCR) in Australian children aged <2 years. METHODS: Children in a community-based birth cohort had gastrointestinal symptoms recorded daily and stool samples collected weekly until their second birthday. Diarrhea was defined as ≥3 liquid or looser than normal stools within a 24-hour period. PCR assays tested for 11 viruses, 5 bacteria, and 4 protozoa. Detections of a new organism or of the same following at least 2 negative tests were linked to ADIs, and incidence rates and estimates of association with ADI were calculated. RESULTS: One hundred fifty-four children provided 11 111 stool samples during 240 child-years of observation, and 228 ADIs were linked to samples. Overall, 6105 (55%) samples tested positive for a target organism. The incidence rate of 2967 new detections was 11.9 (95% confidence interval 11.4-12.3) per child-year, with 2561 (92%) new detections unrelated to an ADI. The relative risk of an ADI was 1.5-6.4 times greater for new detections of adenovirus, enterovirus, norovirus GII, parechovirus A, wild-type rotavirus, sapovirus GI/II/IV/V, Salmonella, Blastocystis, and Cryptosporidium, compared to when these were absent. CONCLUSIONS: Wild-type rotavirus, norovirus GII, sapovirus GI/II/IV/V, adenovirus 40/41, and Salmonella were associated with ADI in this age group and setting. However, high levels of asymptomatic shedding of potential pathogens in stools from children may contribute to diagnostic confusion when children present with an episode of ADI.

The Initial Timing and Burden of Viral Gastrointestinal Infections in Australian Infants: A Birth Cohort Study.

ABSTRACT: The timing and nature of initial infections by potentially vaccine-preventable gastrointestinal viruses (group-F adenoviruses, classic human astrovirus, norovirus I/II, and sapovirus I/II/IV/V) was investigated in a community-based birth cohort. Weekly stool samples were collected from 158 children aged <2 years in an Australian subtropical city. Median age at initial infection was lowest for norovirus II (13.8 months) followed by sapovirus (14.3 months) and classic human astrovirus (17.6 months), and was >24 months for the remaining viruses. Norovirus II and sapovirus were most often associated with acute gastroenteritis symptoms (57% and 44%, respectively). Overall, healthcare was sought for 45% of symptomatic initial infections, which varied between 17% for norovirus I to 55% for norovirus II. Age at initial infection was lower when participants were exposed to other children. Norovirus II and sapovirus were the most important pathogens in this cohort, providing further evidence for them being priority targets for vaccine development.

Diet Quality and Protein-Bound Uraemic Toxins: Investigation of Novel Risk Factors and the Role of Microbiome in Chronic Kidney Disease.

OBJECTIVE: This study aims to explore the associations between diet quality, uraemic toxins, and gastrointestinal microbiota in the chronic kidney disease (CKD) population. METHODS: This is a baseline cross-sectional study of adults with CKD participating in a randomized controlled trial of prebiotic and probiotic supplementation. Dietary intake was measured using a seven-day diet history method, administered by a specialist dietitian. Diet quality was assessed using plant-based diet index (PDI) (overall PDI, healthy PDI, and unhealthy PDI), food group analysis, protein intake, fiber intake, and dietary protein-to-fiber ratio. Serum uraemic toxins (free and total; indoxyl sulfate and p-cresyl sulfate) were determined by ultraperformance liquid chromatography. Gastrointestinal microbiota richness, diversity, composition, and functional capacity were analyzed via metagenomic sequencing. RESULTS: Sixty-eight adults [median age: 70 (interquartile range: 58-75) years, 66% male] with an estimated glomerular filtration rate of 34 ± 11 mL/min/1.73 m2 were included, with 40 participants completing the optional fecal substudy. Dietary fiber intake was associated with lower levels of total indoxyl sulfate, whereas the healthy plant-based diet index was associated with lower levels of free p-cresyl sulfate. A higher protein-to-fiber ratio was associated with an increased relative abundance of unclassified members of order Oscillospirales. Intake of vegetables and whole grains was correlated with Subdoligranulum formicile, whereas an unclassified Prevotella species was correlated with potatoes and food items considered discretionary, including sweet drinks, sweet desserts, and animal fats. CONCLUSIONS: Diet quality may influence uraemic toxin generation and gut microbiota diversity, composition, and function in adults with CKD. Well-designed dietary intervention studies targeting the production of uraemic toxins and exploring the impact on gut microbiome are warranted in the CKD population.

Peripheral vascular catheter use in Latin America (the vascular study): A multinational cross-sectional study.

Background: Peripheral intravenous catheter (PIVC) insertion is one of the most common clinical procedures worldwide, yet little data are available from Latin America. Our aim was to describe processes and practices regarding PIVC use in hospitalized patients related to hospital guidelines, characteristics of PIVC inserters, prevalence of PIVC complications, and idle PIVCs. Methods: In 2019 we conducted a multinational, cross-sectional study of adult and pediatric patients with a PIVC in hospitals from five Latin American countries: Argentina, Brazil, Chile, Colombia, and Mexico. We used two data collection tools to collect hospital guidelines and patient-specific data on the day of the study. The vessel health and preservation (VHP) model guided synthesis of the study aims/questions and suggested opportunities for improvement. Results: A total of 9,620 PIVCs in adult (86%) and pediatric inpatients in 132 hospitals were assessed. Routine replacement 8-72 hourly was recommended for adults in 22% of hospitals, rather than evidence-based clinical assessment-based durations, and 69% of hospitals allowed the use of non-sterile tape rather than the international standard of a sterile dressing. The majority (52%) of PIVCs were inserted by registered nurses (RNs), followed by nursing assistants/technicians (41%). Eight percent of PIVCs had pain, hyperemia, or edema, 6% had blood in the extension tubing/connector, and 3% had dried blood around the device. Most PIVCs had been inserted for intravenous medications (81%) or fluids (59%) in the previous 24 h, but 9% were redundant. Conclusion: Given the variation in policies, processes and practices across countries and participating hospitals, clinical guidelines should be available in languages other than English to support clinician skills and knowledge to improve PIVC safety and quality. Existing and successful vascular access societies should be encouraged to expand their reach and encourage other countries to join in multinational communities of practice.

Synbiotics Easing Renal Failure by Improving Gut Microbiology II (SYNERGY II): A Feasibility Randomized Controlled Trial.

Synbiotics have emerged as a therapeutic strategy for modulating the gut microbiome and targeting novel cardiovascular risk factors, including uremic toxins indoxyl sulfate (IS) and p-cresyl sulfate (PCS). This study aims to evaluate the feasibility of a trial of long-term synbiotic supplementation in adults with stage 3-4 chronic kidney disease (CKD). Adult participants with CKD and estimated glomerular filtration rate (eGFR) of 15-60 mL/min/1.73 m2) were recruited between April 2017 and August 2018 to a feasibility, double-blind, placebo-controlled, randomized trial of synbiotic therapy or matched identical placebo for 12 months. The primary outcomes were recruitment and retention rates as well as acceptability of the intervention. Secondary outcomes were treatment adherence and dietary intake. Exploratory outcomes were evaluation of the cardiovascular structure and function, serum IS and PCS, stool microbiota profile, kidney function, blood pressure, and lipid profile. Of 166 potentially eligible patients, 68 (41%) were recruited into the trial (synbiotic n = 35, placebo n = 33). Synbiotic and placebo groups had acceptable and comparable 12-month retention rates (80% versus 85%, respectively, p = 0.60). Synbiotic supplementation altered the stool microbiome with an enrichment of Bifidobacterium and Blautia spp., resulting in a 3.14 mL/min/1.73 m2 (95% confidence interval (CI), -6.23 to -0.06 mL/min/1.73 m2, p < 0.01) reduction in eGFR and a 20.8 µmol/L (95% CI, 2.97 to 38.5 µmol/L, p < 0.01) increase in serum creatinine concentration. No between-group differences were observed in any of the other secondary or exploratory outcomes. Long-term synbiotic supplementation was feasible and acceptable to patients with CKD, and it modified the gastrointestinal microbiome. However, the reduction in kidney function with synbiotics warrants further investigation.

Peripheral intravenous catheter failure: A secondary analysis of risks from 11,830 catheters.

BACKGROUND: Peripheral intravenous catheters are an essential medical device which are prone to complications and failure. OBJECTIVES: Identify patient, provider and device risk factors associated with all-cause peripheral intravenous catheter failure as well as individual complications: phlebitis, infiltration/occlusion, and dislodgement to improve patient outcomes. DESIGN: Secondary analysis of twelve prospective studies performed between 2008 and 2020. SETTINGS: Australian metropolitan and regional hospitals including one paediatric hospital. PARTICIPANTS: Participants were from medical, surgical, haematology, and oncology units. METHODS: Multilevel mixed-effects parametric survival regression was used to identify factors associated with all-cause peripheral intravenous catheter failure, phlebitis, occlusion/infiltration, and dislodgement. We studied patient (e.g., age, gender), device (e.g., gauge), and provider (e.g., inserting clinician) variables. Stepwise regression involved clinically and p<0.20 significant variables entered into the multivariable model. Results were expressed as hazard ratios (HRs) and 95% confidence intervals (CI); p<0.01 was considered statistically significant. RESULTS: Of 11,830 peripheral intravenous catheters (8,200 participants) failure occurred in 36% (n = 4,263). Occlusion/infiltration incidence was 23% (n = 2,767), phlebitis 12% (n = 1,421), and dislodgement 7% (n = 779) of catheters. Patient factors significantly associated with failure and complications were: female gender (phlebitis; (HR 1.98, 95% CI 1.72-2.27), (infiltration/occlusion; HR 1.45, 95% CI 1.33-1.58), (failure; HR 1.36, 95% CI 1.26-1.46); and each year increase in age (phlebitis; 0.99 HR, 95% CI 0.98-0.99), (failure; 0.99 HR, 95% CI 0.99-0.99). The strongest provider risk factor was intravenous antibiotics (infiltration/occlusion; HR 1.40, 95% CI 1.27-1.53), (phlebitis; HR 1.36, 95% CI 1.18-1.56), (failure; HR 1.26, 95% CI 1.17-1.36). Catheters inserted by vascular access teams were less likely to dislodge (HR 0.53, 95% CI 0.42-0.67). Device risk factors most associated with all-cause failure were wrist/hand (HR 1.34, 95% CI 1.23-1.46), antecubital fossa peripheral intravenous catheters (HR 1.29, 95% CI 1.16-1.44) and 22/24 gauge (HR 1.27, 95% CI 1.12-1.45) catheters. CONCLUSION: Factors identified, including the protective aspect of vascular access team insertion, and high catheter failure associated with intravenous antibiotic administration, will allow targeted updates of peripheral intravenous catheter guidelines and models of care.

The Cost Consequences of the Gold Coast Integrated Care Programme.

INTRODUCTION: The Australian Gold Coast Integrated Care programme trialled a model of care targeting those with chronic and complex conditions at highest risk of hospitalisation with the goal of producing the best patient outcomes at no additional cost to the healthcare system. This paper reports the economic findings of the trial. METHODS: A pragmatic non-randomised controlled study assessed differences between patients enrolled in the programme (intervention group) and patients who received usual care (control group), in health service utilisation, including Medicare Benefits Schedule and Pharmaceutical Benefits Scheme claims, patient-reported outcome measures, including health-related quality of life, mortality risk, and cost. RESULTS: A total of 1,549 intervention participants were enrolled and matched on the basis of patient level data to 3,042 controls. We found no difference in quality of life between groups, but a greater decrease in capability, social support and satisfaction with care scores and higher hospital service use for the intervention group, leading to a greater cost to the healthcare system of AUD$6,400 per person per year. In addition, the per person per year cost of being in the GCIC programme was AUD$8,700 equating to total healthcare expenditures of AUD$15,100 more for the intervention group than the control group. CONCLUSION: The GCIC programme did not show value for money, incurring additional costs to the health system and demonstrating no significant improvements in health-related quality of life. Because patient recruitment was gradual throughout the trial, we had only one year of complete data for analysis which may be too short a period to determine the true cost-consequences of the program.