RESUMO
Our preliminary data and observational studies suggested an increasing "off label" use of oral midodrine as a vasopressor sparing agent in various groups of critically ill patients, including those with sepsis. We designed this clinical trial to evaluate the feasibility of use of midodrine hydrochloride in early sepsis to reduce the duration for IV vasopressors and decrease ICU and hospital length of stay. DESIGN: Pilot, two-center, placebo-controlled, double blinded randomized clinical trial. SETTING: Medical ICUs at Mayo Clinic Rochester and Cleveland Clinic Abu Dhabi were the study sites. PATIENTS AND METHODS: Adult patients (≥ 18 yr old) were included within 24 hours of meeting the Sepsis-3 definition if the mean arterial pressure remained less than 70 mm Hg despite receiving timely antibiotics and initial IV fluid bolus of 30 cc/kg. INTERVENTION: Three doses of 10 mg midodrine versus placebo were administered. MEASUREMENTS AND MAIN RESULTS: Total 32 patients were randomized into midodrine (n = 17) and placebo groups (n = 15). There were no major differences in baseline variables between the groups except for higher baseline creatinine in the midodrine group (2.0 ± 0.9 mg/dL) versus placebo group (1.4 ± 0.6 mg /dL), p = 0.03. The median duration of IV vasopressor requirement was 14.5 ± 8.1 hours in midodrine group versus 18.8 ± 7.1 hours in the placebo group, p value equals to 0.19. Patients in the midodrine group needed 729 ± 963 norepinephrine equivalent compared with 983 ± 1,569 norepinephrine equivalent in the placebo group, p value equals to 0.59. ICU length of stay was 2.29 days (interquartile range, 1.65-3.9 d) in the midodrine group, compared with 2.45 days (interquartile range, 1.6-3.2 d) in the placebo group, p value equals to 0.36. No serious adverse events were observed in either group. CONCLUSIONS: Phase II clinical trial powered for clinical outcomes (duration of vasopressor use, need for central venous catheter, and ICU and hospital length of stay) is justified.
RESUMO
BACKGROUND: Low-molecular-weight heparin (LMWH) is an effective means of preventing venous thromboembolism (VTE) among medical inpatients. Compared with unfractionated heparin, LMWH is equivalent or superior in efficacy and risk of bleeding. Despite its advantages, LMWH is underused in VTE prophylaxis for general-medicine patients hospitalized at our institution. Thus, a quality improvement (QI) initiative was undertaken to increase LMWH use for VTE prophylaxis among medical patients hospitalized on resident teaching services. METHODS: A QI team was formed, consisting of resident and attending physicians with pharmacy leaders. A systems analysis was performed, which showed gaps in resident knowledge as the greatest barrier to LMWH use. A knowledge translation framework was used to improve prescribing practices. Several Plan-Do-Study-Act cycles were executed, including resident-of-resident and pharmacist-of-resident education with performance audit and feedback. RESULTS: Pharmacist-of-resident education elicited the largest improvement and was sustained through a recurring pharmacist-led, interprofessional educational session as part of the monthly hospital orientation for incoming residents. Data analysis showed a statistically significant increase in LMWH use among treatment-eligible hospitalized medical patients, from 12.1% to 69.2%, following intervention (P<0.001). Extrapolated over 1 year, this improvement conserved 9,490 injections and nearly 791 hours of nurse time. CONCLUSIONS: This QI project indicates that an interprofessional education intervention can lead to sustainable improvement in resident prescribing practices. This project also highlights the value of knowledge translation for the design of tailored interventions in QI initiatives.
