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- Title
Safety and Efficacy of Midline vs Peripherally Inserted Central Catheters Among Adults Receiving IV Therapy: A Randomized Clinical Trial.
- Authors
Thomsen, Simon L.; Boa, Rikke; Vinter-Jensen, Lars; Rasmussen, Bodil S.
- Abstract
Key Points: Question: Is the use of midline catheters (MCs) a safe and more efficacious alternative to peripherally inserted central catheters (PICCs) for adult patients receiving medium- to long-term intravenous therapy? Findings: In this randomized clinical trial of 304 patients, rates of catheter-related bloodstream infection did not differ between the catheter groups. The MC group had a statistically significantly higher catheter-related complication rate, with an incidence rate ratio of 2.37 compared with the PICC control group. Meaning: In this study, MCs and PICCs were both safe and efficacious, and despite the MC group having a higher complication rate, MCs could be an alternative to PICCs. This randomized clinical trial compares the safety and efficacy of midline catheters vs peripherally inserted central catheters among adult patients with an anticipated intravenous (IV) therapy lasting from 5 to 28 days. Importance: Midline catheters (MCs) are widely used, but safety and efficacy compared with peripherally inserted central catheters (PICCs) has not been adequately evaluated. Objective: To compare the safety and efficacy of MCs with PICCs among adult patients with an anticipated intravenous therapy lasting from 5 to 28 days. Design, Setting, and Participants: This parallel, 2-group, open-label, randomized clinical trial (RCT) was conducted in Denmark from October 2018 to February 2022 at a single academic tertiary care center. Adult inpatients and outpatients were consecutively randomized. Intervention: Patients were randomized in a 1:1 ratio to either the MC group or the PICC control group. Main Outcomes and Measures: The primary outcome was catheter-related bloodstream infection (CRBSI), analyzed using the Fisher exact test. Secondary outcomes were symptomatic catheter-related thrombosis and catheter failure, including mechanical cause, phlebitis, infiltration, pain in relation to drug or fluid administration, and leaking from the puncture site. Incidence rate ratios (IRRs) were calculated to assess between-group failure rates over device dwell time using Poisson regression. An intention-to-treat analysis was performed. Results: A total of 304 patients (mean [SD] age, 64.6 [13.5] years; 130 [42.8%] female) were included in the analysis, and 152 patients were allocated to each catheter group. The incidence of CRBSI was low, with 0 in the MC group and 1 in the PICC control group (P >.99). The MC group had a higher catheter-related complication rate (20 [13.2%] vs 11 [7.2%]), and an IRR of 2.37 (95% CI, 1.12-5.02; P =.02) for complications compared with the PICC control group. In a post hoc analysis stratified by catheter dwell time, no significant difference in complication rate (IRR, 1.16; 95% CI, 0.50-2.68; P =.73) was found between the 2 groups for catheters used less than 16 days. Conclusions and Relevance: In this RCT with patients who received medium- to long-term intravenous therapy, the incidence of CRBSI was low, with no difference between MCs and PICCs. The use of MCs resulted in a higher incidence of catheter-related complications compared with use of PICCs. This finding should be balanced in the decision of type of catheter used at the individual patient level. Trial Registration: ClinicalTrials.gov Identifier: NCT04140916
- Subjects
DENMARK; INTRAVENOUS therapy; CONFIDENCE intervals; PERIPHERALLY inserted central catheters; TREATMENT duration; TERTIARY care; FISHER exact test; MANN Whitney U Test; TREATMENT effectiveness; RANDOMIZED controlled trials; COMPARATIVE studies; DESCRIPTIVE statistics; RESEARCH funding; VASCULAR catheters; STATISTICAL sampling; DATA analysis software; PATIENT safety; ADULTS
- Publication
JAMA Network Open, 2024, Vol 7, Issue 2, pe2355716
- ISSN
2574-3805
- Publication type
Article
- DOI
10.1001/jamanetworkopen.2023.55716