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Summary Background The millions of peripheral intravenous catheters used each year are recommended for 72–96 h replacement in adults. This routine replacement increases health-care costs and staff workload and requires patients to undergo repeated invasive procedures. The effectiveness of the practice is not well established. Our hypothesis was that clinically indicated catheter replacement is of equal benefit to routine replacement. Methods This multicentre, randomised, non-blinded equivalence trial recruited adults (≥18 years) with an intravenous catheter of expected use longer than 4 days from three hospitals in Queensland, Australia, between May 20, 2008, and Sept 9, 2009. Computer-generated random assignment (1:1 ratio, no blocking, stratified by hospital, concealed before allocation) was to clinically indicated replacement, or third daily routine replacement. Patients, clinical staff, and research nurses could not be masked after treatment allocation because of the nature of the intervention. The primary outcome was phlebitis during catheterisation or within 48 h after removal. The equivalence margin was set at 3%. Primary analysis was by intention to treat. Secondary endpoints were catheter-related bloodstream and local infections, all bloodstream infections, catheter tip colonisation, infusion failure, catheter numbers used, therapy duration, mortality, and costs. This trial is registered with the Australian New Zealand Clinical Trials Registry, number ACTRN12608000445370. Findings All 3283 patients randomised (5907 catheters) were included in our analysis (1593 clinically indicated; 1690 routine replacement). Mean dwell time for catheters in situ on day 3 was 99 h (SD 54) when replaced as clinically indicated and 70 h (13) when routinely replaced. Phlebitis occurred in 114 of 1593 (7%) patients in the clinically indicated group and in 114 of 1690 (7%) patients in the routine replacement group, an absolute risk difference of 0·41% (95% CI −1·33 to 2·15%), which was within the prespecified 3% equivalence margin. No serious adverse events related to study interventions occurred. Interpretation Peripheral intravenous catheters can be removed as clinically indicated; this policy will avoid millions of catheter insertions, associated discomfort, and substantial costs in both equipment and staff workload. Ongoing close monitoring should continue with timely treatment cessation and prompt removal for complications. Funding Australian National Health and Medical Research Council.

The optimal duration of infusion set use to prevent life-threatening catheter-related bloodstream infection (CRBSI) is unclear. We aimed to compare the effectiveness and costs of 7-day (intervention) versus 4-day (control) infusion set replacement to prevent CRBSI in patients with central venous access devices (tunnelled cuffed, non-tunnelled, peripherally inserted, and totally implanted) and peripheral arterial catheters. We did a randomised, controlled, assessor-masked trial at ten Australian hospitals. Our hypothesis was CRBSI equivalence for central venous access devices and non-inferiority for peripheral arterial catheters (both 2% margin). Adults and children with expected greater than 24 h central venous access device–peripheral arterial catheter use were randomly assigned (1:1; stratified by hospital, catheter type, and intensive care unit or ward) by a centralised, web-based service (concealed before allocation) to infusion set replacement every 7 days, or 4 days. This included crystalloids, non-lipid parenteral nutrition, and medication infusions. Patients and clinicians were not masked, but the primary outcome (CRBSI) was adjudicated by masked infectious diseases physicians. The analysis was modified intention to treat (mITT). This study is registered with the Australian New Zealand Clinical Trials Registry ACTRN12610000505000 and is complete. Between May 30, 2011, and Dec, 9, 2016, from 6007 patients assessed, we assigned 2944 patients to 7-day (n=1463) or 4-day (n=1481) infusion set replacement, with 2941 in the mITT analysis. For central venous access devices, 20 (1·78%) of 1124 patients (7-day group) and 16 (1·46%) of 1097 patients (4-day group) had CRBSI (absolute risk difference [ARD] 0·32%, 95% CI −0·73 to 1·37). For peripheral arterial catheters, one (0·28%) of 357 patients in the 7-day group and none of 363 patients in the 4-day group had CRBSI (ARD 0·28%, −0·27% to 0·83%). There were no treatment-related adverse events. Infusion set use can be safely extended to 7 days with resultant cost and workload reductions. Australian National Health and Medical Research Council.

Objectives Arterial catheters (ACs) are critical for haemodynamic monitoring and blood sampling but are prone to complications. We investigated the incidence and risk factors of AC failure. Methods Secondary analysis of a multi-centre randomised controlled trial (ACTRN 12610000505000). Analysis included a subset of adult intensive care unit patients with an AC. The primary outcome was all-cause device failure. Secondary outcomes were catheter associated bloodstream infection (CABSI), suspected CABSI, occlusion, thrombosis, accidental removal, pain, and line fracture. Risk factors associated with AC failure were investigated using Cox proportional hazards and competing-risk models. Results Of 664 patients, 173 (26%) experienced AC failure (incidence rate [IR] 37/1000 catheter days). Suspected CABSI was the most common failure type (11%; IR 15.3/1000 catheter days), followed by occlusion (8%; IR 11.9/1,000 catheter days), and accidental removal (4%; IR 5.5/1000 catheter days). CABSI occurred in 16 (2%) patients. All-cause failure and occlusion were reduced with ultrasound-assisted insertion (failure: adjusted hazard ratio [HR] 0.43, 95% CI 0.25, 0.76; occlusion: sub-HR 0.11, 95% CI 0.03, 0.43). Increased age was associated with less AC failure (60–74 years HR 0.63, 95% CI 0.44 to 0.89; 75 + years HR 0.36, 95% CI 0.20, 0.64; referent 15–59 years). Females experienced more occlusion (adjusted sub-HR 2.53, 95% CI 1.49, 4.29), while patients with diabetes had less (SHR 0.15, 95% CI 0.04, 0.63). Suspected CABSI was associated with an abnormal insertion site appearance (SHR 2.71, 95% CI 1.48, 4.99). Conclusions AC failure is common with ultrasound-guided insertion associated with lower failure rates. Trial registration Australian New Zealand Clinical Trial Registry (ACTRN 12610000505000); date registered: 18 June 2010.

Strategies to prevent pyrexia in patients with acute neurological injury may reduce secondary neuronal damage. The aim of this study was to determine the safety and efficacy of the routine administration of 6 grams/day of intravenous paracetamol in reducing body temperature following severe traumatic brain injury, compared to placebo. A multicentre, randomised, blind, placebo-controlled clinical trial in adult patients with traumatic brain injury (TBI). Patients were randomised to receive an intravenous infusion of either 1g of paracetamol or 0.9% sodium chloride (saline) every 4 hours for 72 hours. The primary outcome was the mean difference in core temperature during the study intervention period. Forty-one patients were included in this study: 21 were allocated to paracetamol and 20 to saline. The median (interquartile range) number of doses of study drug was 18 (17-18) in the paracetamol group and 18 (16-18) in the saline group (P = 0.85). From randomisation until 4 hours after the last dose of study treatment, there were 2798 temperature measurements (median 73 [67-76] per patient). The mean ± standard deviation temperature was 37.4±0.5°C in the paracetamol group and 37.7±0.4°C in the saline group (absolute difference -0.3°C; 95% confidence interval -0.6 to 0.0; P = 0.09). There were no significant differences in the use of physical cooling, or episodes of hypotension or hepatic abnormalities, between the two groups. The routine administration of 6g/day of intravenous paracetamol did not significantly reduce core body temperature in patients with TBI. Australian New Zealand Clinical Trials Registry ACTRN12609000444280.

Objective To compare colonization and catheter-related bloodstream infection (CR-BSI) rates among three insertion sites (subclavian, internal jugular, femoral) used for central venous catheter (CVC) placement. Design Twenty-four-month prospective study, with relative effects analyzed by Cox proportional hazards regression. Setting Eight-bed intensive care unit. Patients Four hundred and ten critically ill patients requiring CVC placement. Measurements and results All short-term multi-lumen CVCs, including antimicrobial-coated devices, were studied with management standardized. Six hundred and five CVCs (4,040 catheter days) were analyzed. Colonization and CR-BSI incidence were, respectively, 15.1 (95% CI 13.5–21.0) and 1.8 (95% CI 1.2–4.2) per 1,000 catheter-days. Colonization was higher at the internal jugular (HR 3.64; 95% CI 1.32–10.00; p  = 0.01) and femoral (HR 5.15; 95% CI 1.82–14.51; p  = 0.004) sites than at the subclavian site. The femoral site carried a greater risk of being colonized by non- S. epidermidis species than the subclavian and internal jugular sites combined (HR 4.15; 95% CI 1.79–9.61; p  = 0.001). CVCs inserted in the Department of Emergency Medicine were more colonized than those inserted in the ICU or operating room (HR 2.66; 95% CI 1.27–5.56; p  = 0.01), and CVCs were less colonized in females than in males (HR 0.49; 95% CI 0.26–0.89; p  = 0.02). No difference in CR-BSI rates was noted between the three sites. Conclusions Colonization was lowest at the subclavian site. Regional differences exist with respect to type of pathogen isolated. Colonization was influenced by insertion location and gender. The incidence of CR-BSI was not different.

A 28-year-old woman, a park ranger, developed acute Q fever with associated sepsis, profound jaundice, disseminated intravascular coagulation and multiorgan failure necessitating prolonged admission to the intensive care unit for ventilatory support. She recovered fully and remains well 4 years later.

Purpose To assess the utility of two in situ techniques, differential time to positivity (DTP) and semiquantitative superficial cultures (SQSC) for diagnosing catheter-related bloodstream infection (CR-BSI) in critically ill adults. Methods This was a prospective cohort study in patients with suspected CR-BSI arising from a short-term arterial catheter (AC) or a central venous catheter (CVC). On suspicion of CR-BSI, devices were removed. Blood, skin, catheter tip and hub cultures were taken. Infection rates were compared against the diagnosis of CR-BSI using matched tip and blood cultures. Results Of 120 episodes of clinically suspected CR-BSI in 101 patients examined, 9 (7.5 %) were confirmed as CR-BSI. Validity values (95 % CI) for the diagnosis of CR-BSI arising from both AC and CVC for DTP were: sensitivity 44 % (15–77 %), specificity 98 % (93–100 %), positive predictive value (PPV) 67 % (24–94 %), negative predictive value (NPV) 96 % (90–98 %), positive likelihood ratio (LR+) 25 (5–117), negative likelihood ratio (LR−) 0.6 (0.3–1.0), diagnostic odds ratio (DOR) 44 (7–258), and accuracy 94 % (92–98 %). Validity values (95 % CI) for SQSC were: sensitivity 78 % (41–96 %), specificity 60 % (50–69 %), PPV 14 % (6–26 %), NPV 97 % (89–99 %), LR+ 1.9 (1.0–2.3), LR− 0.4 (0.1–1.3), DOR 5.1 (1.1–19), and accuracy 61 % (51–69 %). DTP combined with SQSC improved sensitivity and NPV to 100 % whilst the DOR increased to 25.8 (95 % CI 3–454). Conclusions CR-BSI can be ruled out by undertaking DTP and SQSC concurrently for both ACs and CVCs with 100 % sensitivity and NPV.

Background Intravascular catheter related infection (CRI) is one of the most serious nosocomial infections. Diagnostic criteria include a positive culture from the catheter tip along with blood, yet in many patients with signs of infection, current culture techniques fail to identify pathogens on catheter segments. We hypothesised that a molecular examination of the bacterial community on short term arterial catheters (ACs) would improve our understanding of the variety of organisms that are present in this niche environment and would help develop new methods for the diagnosis of CRI. Results The whole bacterial community presenting on all ACs was evaluated by molecular methods, i.e., a strategy of whole community DNA extraction, PCR amplification followed by cloning and 16S rDNA sequence analysis. Ten ACs were removed from patients suspected of CRI and 430 clones from 5 \"colonised\" and 5 \"uncolonised\" (semi-quantitative method) AC libraries were selected for sequencing and subsequent analysis. A total of 79 operational taxonomic units (OTUs) were identified at the level of 97% similarity belonging to six bacterial divisions. An average of 20 OTUs were present in each AC, irrespective of colonisation status. Conventional culture failed to reveal the majority of these bacteria. Conclusions There was no significant difference in the bacterial diversity between the 'uncolonised' and 'colonised' ACs. This suggests that vascular devices cultured conventionally and reported as non infective may at times potentially be a significant source of sepsis in critically ill patients. Alternative methods may be required for the accurate diagnosis of CRI in critically ill patients.

Introduction Vascular access devices (VADs), such as peripheral or central venous catheters, are vital across all medical and surgical specialties. To allow therapy or haemodynamic monitoring, VADs frequently require administration sets (AS) composed of infusion tubing, fluid containers, pressure-monitoring transducers and/or burettes. While VADs are replaced only when necessary, AS are routinely replaced every 3–4 days in the belief that this reduces infectious complications. Strong evidence supports AS use up to 4 days, but there is less evidence for AS use beyond 4 days. AS replacement twice weekly increases hospital costs and workload. Methods and analysis This is a pragmatic, multicentre, randomised controlled trial (RCT) of equivalence design comparing AS replacement at 4 (control) versus 7 (experimental) days. Randomisation is stratified by site and device, centrally allocated and concealed until enrolment. 6554 adult/paediatric patients with a central venous catheter, peripherally inserted central catheter or peripheral arterial catheter will be enrolled over 4 years. The primary outcome is VAD-related bloodstream infection (BSI) and secondary outcomes are VAD colonisation, AS colonisation, all-cause BSI, all-cause mortality, number of AS per patient, VAD time in situ and costs. Relative incidence rates of VAD-BSI per 100 devices and hazard rates per 1000 device days (95% CIs) will summarise the impact of 7-day relative to 4-day AS use and test equivalence. Kaplan-Meier survival curves (with log rank Mantel-Cox test) will compare VAD-BSI over time. Appropriate parametric or non-parametric techniques will be used to compare secondary end points. p Values of <0.05 will be considered significant. Ethics and dissemination Relevant ethical approvals have been received. CONSORT Statement recommendations will be used to guide preparation of any publication. Results will be presented at relevant conferences and sent to the major organisations with clinical practice guidelines for VAD care. Trial registration number Australian New Zealand Clinical Trial Registry (ACTRN 12610000505000).

High-dose paracetamol (6 g/day) is a low-cost intervention that may prevent pyrexia. The purpose of this study was to describe the pharmacokinetics of high-dose intravenous paracetamol, in patients with traumatic brain injury (TBI). A clinical pharmacokinetic study in adult patients with TBI was performed as a sub-study to a prospective, phase 2B, randomized placebo-controlled study (PARITY). Patients received 1 g of intravenous paracetamol or 0.9% sodium chloride every 4 h for 72 h. All patients were included in the pharmacokinetic sub-study. The mean age, weight and area under the concentration-time curve for the sampled dosing interval were 34.5 yr, 82.3 kg and 39.9 ± 19.8 mg.h/L, respectively. The concentrations observed in the study patients were well below the threshold of toxicity and there was no evidence of accumulation of paracetamol. Paracetamol clearance was found to be high and variable (25.7 L.h−1, coefficient of variation (CV) 40.9%), and a wide range of volume of distribution observed (27.6 L, CV 30.6%). A relationship between lower Glasgow coma scores and higher clearance of paracetamol was observed. Due to altered pharmacokinetics, patients experiencing severe TBI may require a higher dose of paracetamol to achieve drug exposure that results in preventing pyrexia. •Highly variable volumes of distribution and clearance for IV paracetamol were observed.•Lower Glasgow coma scores were associated with higher clearance of paracetamol.•Paracetamol concentrations were below toxicity threshold with no evidence of accumulation.