Inhibit progression of coronary artery calcification with vitamin K in hemodialysis patients (the iPACK-HD study): a randomized, placebo-controlled multi-center, pilot trial.

BACKGROUND: Vitamin K activates matrix Gla protein (MGP), a key inhibitor of vascular calcification. There is a high prevalence of sub-clinical vitamin K deficiency in patients with end-stage kidney disease. METHODS: A parallel randomized placebo-controlled pilot trial was designed to determine whether 10 mg of phylloquinone thrice weekly versus placebo modifies coronary artery calcification progression over 12 months in patients requiring hemodialysis with a coronary artery calcium score (CAC) ≥30 Agatston Units (ClinicalTrials.gov identifier NCT01528800). The primary outcome was feasibility (recruitment rate, compliance with study medication, study completion and adherence overall to study protocol). CAC score was used to assess calcification at baseline and 12 months. Secondary objectives were to explore the impact of phylloquinone on vitamin K-related biomarkers (phylloquinone, dephospho-uncarboxylated MGP and the Gla-osteocalcin to Glu-osteocalcin ratio) and events of clinical interest. RESULTS: A total of 86 patients with a CAC score ≥30 Agatston Units were randomized to either 10 mg of phylloquinone or a matching placebo three times per week. In all, 69 participants (80%) completed the trial. Recruitment rate (4.4 participants/month) and medication compliance (96%) met pre-defined feasibility criteria of ≥4.17 and ≥90%, respectively. Patients randomized to phylloquinone for 12 months had significantly reduced levels of dephospho-uncarboxylated MGP (86% reduction) and increased levels of phylloquinone and Gla-osteocalcin to Glu-osteocalcin ratio compared with placebo. There was no difference in the absolute or relative progression of coronary artery calcification between groups. CONCLUSION: We demonstrated that phylloquinone treatment improves vitamin K status and that a fully powered randomized trial may be feasible.

Study protocol for DICE trial: Video-assisted thoracoscopic surgery decortication versus interventional radiology guided chest tube insertion for the management of empyema.

BACKGROUND: Empyema is a common thoracic surgery presentation, defined as pus in the pleural space. Despite the commonality of empyema, consensus on initial management remains ambiguous. Two standard of care treatment options include inserting a chest tube (thoracostomy) and the administration of intrapleural fibrinolytics, or an initial surgical approach, surgical decortication. Due to the complexity of this pleural space infection, often repeat interventions are required after initial management in order to achieve source control and resolution of clinical symptoms. This study aims to identify the most effective initial management option for empyema. STUDY DESIGN: We present a study protocol for a randomized control trial (RCT) comparing adult individuals with empyema to one of two standard of care initial management options. Participants will be randomized into either interventional radiology guided chest tube insertion with intrapleural fibrinolytics (Dornase 5 mg and Alteplase 10 mg intrapleural twice daily for three days) or video-assisted thoracoscopic surgery (VATS) decortication. METHODS: All adults with empyema meeting inclusion criteria will be invited to participate. They will be randomized into one of two intervention groups; interventional radiology guided chest tube insertion with fibrinolytics or initial VATS decortication. Each intervention will take place within 48 hours of randomization. The primary outcome will be the rate of re-intervention within 30 days. Re-intervention is defined as repeat chest tube insertion, VATS decortication, or decortication via thoracotomy. Secondary outcomes include a change in the size of empyema, length of stay, morbidity, as well as 30-day and 90-day mortality, as well as quality of life measurements. ANTICIPATED IMPACT: This study is aimed at identifying the most effective initial management option for individuals with empyema.

Effect of a nurse team coordinator on outcomes for hospitalized medicine patients.

PURPOSE: Several randomized trials have found that discharge planning improves outcomes for hospitalized patients. We do not know if adding a clinical nurse specialist (CNS) to physician teams in hospitals that already have discharge planning services makes a difference. METHODS: In 2 teaching hospitals, patients were randomly assigned to regular hospital care or care with a clinical nurse specialist. The clinical nurse specialist facilitated hospital care by retrieving preadmission information, arranging in-hospital consultations and investigations, organizing postdischarge follow-up visits, and checking up on patients postdischarge with a telephone call. In-hospital outcomes included mortality and length of stay. Postdischarge outcomes included time to readmission or death, patient satisfaction, and the risk of adverse event. Adverse events were poor outcomes due to medical care rather than the natural history of disease. RESULTS: A total of 620 sequential patients were randomized (CNS n = 307, control n = 313), of which 361 were followed after discharge from hospital (CNS n = 175, control n = 186). The groups were similar for the probability of in-hospital death (CNS 9.3% vs control 9.7%) or being discharged to the community (58.0% vs 60.0%). The groups did not differ for postdischarge outcomes including readmission or death (21.6% vs 15.6%; P = 0.16) or risk of adverse event (23.6% vs 22.8%). Mean [SD] patient ratings of overall quality of care on a scale of 10 was higher in the clinical nurse specialist group (8.2 [2.2] vs 7.6 [2.4]; P = 0.052). CONCLUSION: The addition of a clinical nurse specialist to a medical team improved patient satisfaction but did not impact hospital efficiency or patient safety.

Adverse events among medical patients after discharge from hospital.

BACKGROUND: Adverse events (AEs) are adverse outcomes caused by medical care. Several studies have indicated that a substantial number of patients experience AEs before or during hospitalization. However, few data describe AEs after hospital discharge. We determined the incidence, severity, preventability and ameliorability of AEs in patients discharged from the general internal medicine service of a Canadian hospital. METHODS: At a multisite Canadian teaching hospital, we prospectively studied patients who were consecutively discharged home or to a seniors' residence from the general internal medicine service during a 14-week interval in 2002. We used telephone interview and chart review to identify outcomes after discharge. Two physicians independently reviewed each outcome to determine if the patient experienced an AE. The severity, preventability and ameliorability of all AEs were classified. RESULTS: During the study period, outcomes were determined for 328 of the 361 eligible patients, who averaged 71 years of age (interquartile range 54-81 years). After discharge, 76 of the 328 patients experienced at least 1 AE (overall incidence 23%, 95% confidence interval [CI] 19%-28%). The AE severity ranged from symptoms only (68% of the AEs) or symptoms associated with a nonpermanent disability (25%) to permanent disability (3%) or death (3%). The most common AEs were adverse drug events (72%), therapeutic errors (16%) and nosocomial infections (11%). Of the 76 patients, 38 had an AE that was either preventable or ameliorable (overall incidence 12%, 95% CI 9%-16%). INTERPRETATION: Approximately one-quarter of patients in our study had an AE after hospital discharge, and half of the AEs were preventable or ameliorable.