Objectives: This pilot trial evaluated the feasibility and safety of an early discharge strategy (EDS: ≤72 h, followed by outpatient lifestyle interventions), in comparison with a conventional discharge strategy (CDS) for low-risk (Zwolle risk score ≤3) ST-elevation myocardial infarction (STEMI) patients treated with primary angioplasty. Methods: One hundred patients were randomized to an EDS (n = 54) or a CDS (n = 46). The primary end point was the feasibility of the EDS: (1) ≥70% of EDS patients discharged ≤72 h, (2) ≥70% visited by a nurse ≤7 days after discharge, (3) ≥70% with ≥3 visits by the nurse and (4) ≥70% visited by a cardiologist ≤3 months. Results: The mean age was 59.2 ± 12.2 years and ejection fraction 54.0 ± 7.1%. Eighty-six percent were male (12% diabetics). Vascular access was radial in 91%. Ischemic time was ≤4 h in 75%. Length of stay was shorter in EDS as compared with CDS (70.1 ± 8.1 vs. 111.8 ± 28.3 h, p < 0.001). EDS feasibility was: (1) 72.2%; (2) 81.5%; (3) 76.9%; (4) 72.2%. There were no adverse events or differences in intervention goals and quality of life between groups. Conclusions: An EDS in low-risk STEMI patients is feasible and seems to be safe. A shorter hospital stay could benefit patients and health care systems.
BackgroundPatients with non-acute spinal cord injury that carry indwelling urinary catheters have an increased risk of urinary tract infection (UTIs). Antiseptic Silver Alloy-Coated Silicone Urinary Catheters seems to be a promising intervention to reduce UTIs; however, actual evidence cannot be extrapolated to spinal cord injured patients. The aim of this trial is to make a comparison between the use of antiseptic silver alloy-coated silicone urinary catheters and the use of standard urinary catheters in spinal cord injured patients to prevent UTIs.Methods/DesignThe study will consist in an open, randomized, multicentre, and parallel clinical trial with blinded assessment. The study will include 742 spinal cord injured patients who require at least seven days of urethral catheterization as a method of bladder voiding. Participants will be online centrally randomized and allocated to one of the two study arms (silver alloy-coated or standard catheters). Catheters will be used for a maximum period of 30 days or removed earlier if the clinician considers it necessary. The main outcome will be the incidence of UTIs by the time of catheter removal or at day 30 after catheterization, the event that occurs first. Intention-to-treat analysis will be performed, as well as a primary analysis of all patients.DiscussionThe aim of this study is to assess whether silver alloy-coated silicone urinary catheters improve ITUs in spinal cord injured patients. ESCALE is intended to be the first study to evaluate the efficacy of the silver alloy-coated catheters in spinal cord injured patients.Trial registrationNCT01803919
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