Elsevier

The Lancet

Volume 380, Issue 9847, 22–28 September 2012, Pages 1066-1074
The Lancet

Articles
Routine versus clinically indicated replacement of peripheral intravenous catheters: a randomised controlled equivalence trial

https://doi.org/10.1016/S0140-6736(12)61082-4Get rights and content

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.

Introduction

Up to 70% of patients in acute care hospitals need a short peripheral intravenous catheter; about 200 million are used each year in the USA alone.1, 2 Intravenous catheters frequently fail before the end of treatment because of irritation of the vein (phlebitis) with symptoms including pain, swelling, redness, occlusion, and a palpable venous cord. Phlebitis necessitates catheter removal and replacement. Peripheral intravenous catheter-related bloodstream infection is a less frequent but serious complication, occuring in about 0·1% of intravenous catheters or 0·5 per 1000 catheter days.3

Intravenous catheters are often needed for a week or more, but have been recommended for regular removal and replacement with a new catheter in an attempt to decrease both phlebitis and infection. Replacement requires additional needlesticks for patients, increases work for clinical staff, and contributes to insertion of intravenous catheters being the most common invasive medical procedure and therefore a substantial contributor to health-care costs.2 Routine intravenous catheter replacement no more frequently than every 72–96 hours is currently recommended for adults by the US Centers for Disease Control and Prevention (CDC).4 By contrast, the CDC recommends not to routinely replace intravenous catheters in children, or in high-risk catheters, such as arterial, haemodialysis, and central venous catheters, for which research has shown routine replacement does not prevent infection.4, 5

Modern intravenous catheters are made of low-irritant materials and might not need routine replacement. Results of well-designed observational studies have shown that longer dwell time increases daily phlebitis risk in a linear rather than exponential manner (ie, more intravenous catheter days overall increases risk, but later days of cannulation are not higher risk than earlier days).6, 7, 8 Thus, routine replacement of intravenous catheters might not benefit patients overall, since the same number of complications might be spread between larger numbers of devices. In 2007–10, results of four randomised controlled trials (n=200–755) supported clinically indicated removal of intravenous catheters as a safe alternative to routine replacement.9, 10, 11, 12 Despite this evidence, concerns have remained about whether abandoning this established practice would increase bloodstream infections.1 The 2011 CDC guidelines designate clinically indicated replacement of intravenous catheters as an unresolved issue, indicating that more research is needed.4

We aimed to understand the effect of extension of intravenous catheter dwell-time beyond 3 days with replacement of catheters only for clinical reasons. We postulated that patients who had intravenous catheters replaced when clinically indicated would have equivalent rates of phlebitis, and no difference in other complications, but reduced costs and number of catheter insertions, compared with patients with catheters removed every third day.

Section snippets

Study design and participants

We did this multicentre, non-blinded, randomised controlled equivalence trial in three university-affiliated, government hospitals in Queensland, Australia (Royal Brisbane and Women's Hospital, Herston; Princess Alexandra Hospital, Woolloongabba; and Gold Coast Hospital, Southport). Recruitment was from May 20, 2008, until the target sample size was achieved on Sept 9, 2009.

Research nurses screened medical and surgical units daily for participants. Patients aged at least 18 years with an

Results

Of 3379 eligible patients, 3283 were enrolled, and no patient withdrew consent (figure 1). In total, we studied 5907 intravenous catheters and 17 412 catheter days (clinically indicated 8693 days; routine replacement 8719 days). Table 1, Table 2 show patient and catheter characteristics. Protocol adherence was 85% in the clinically indicated group and 70% in the routine replacement group (figure 1). Of 1593 patients in the clinically indicated group, 1351 had 1844 intravenous catheters in place

Discussion

Phlebitis occurred in 7% of patients when intravenous catheters were removed when clinically indicated and when they were removed routinely every 3 days. The absolute difference was small (0·41%) and within the prestated 3% equivalence margin. We accepted the equivalence hypothesis and results were consistent across all analyses including per patient, per protocol, per catheter, and per 1000 catheter days. Likewise, study groups had equivalent occurrence of catheter-related bloodstream

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