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临床试验/NCT01949727
NCT01949727已完成不适用

COPD Hospitalization:Examining Pulmonary and Cardiovascular Outcomes in Chronic Obstructive Pulmonary Disease Inpatients (AIM 1). COPD Rehabilitation:Examining the Impact of Early Pulmonary Rehabilitation on Discharged COPD Patients (AIM 2)

University of Alberta1 个研究点 分布在 1 个国家目标入组 111 人开始时间: 2013年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
111
试验地点
1
主要终点
Change in Inflammatory markers

研究概览

简要总结

Chronic obstructive pulmonary disease (COPD) is a chronic lung disease primarily caused by smoking. COPD creates a tremendous burden to the healthcare system, as disease exacerbations result in frequent, prolonged hospitalizations. While originally considered a disease specific to the lung, data have shown that COPD is associated with substantial cardiovascular (CV) morbidity and mortality. Exacerbations of COPD requiring hospitalization result in marked patient deterioration, and heightened CV risk. The cause of the increased CV risk with stable COPD, and the exaggerated CV risk during exacerbations of the disease are unknown; however, it may be due to chronic inflammation which is exacerbated with a flare-up of the disease, and/or chronic inactivity which is similarly worsened with bed-rest during a hospitalization. Despite the impact of COPD on healthcare, there are relatively few studies examining how COPD inpatient care impacts on patient outcomes, inflammation and CV risk. Disease management programs, such as pulmonary rehabilitation and patient self-management education, are part of guideline therapy for COPD; however, these are not regularly implemented following a hospitalization, and how these interventions affect patient outcomes, behavior, physical activity, inflammation and CV risk have not been well studied. The proposed long-term project will examine how typical inpatient COPD care, and how early referral to chronic disease management programs after hospital discharge, affect patient outcomes. This grant brings together an outstanding group of researchers who have the necessary clinical, content and methodological expertise to successfully complete this work. These studies will provide invaluable information about inpatient and outpatient management for a disease which has a tremendous impact on healthcare.

详细描述

AIM 1:

Purpose: To examine pulmonary and cardiovascular outcomes in COPD patients from the time of their acute hospital admission until discharge.

Rationale: AECOPD is associated with systemic inflammation, prolonged bed-rest and increased CV risk. Proper medical management strategies such as appropriate systemic corticosteroids, mobilization, and bedside education may reduce systemic inflammation and improve vascular function, while improving patient self-efficacy and health outcomes and reducing hospital length of stay (LOS).

Hypothesis: Treatment-specific factors such as pharmacological management, patient education and inpatient mobilization will affect LOS, as well as pulmonary and cardiovascular outcomes at discharge.

Study Design: For this cross-sectional study, consecutive patients admitted to the University of Alberta Hospital Pulmonary ward with a diagnosis of an AECOPD (with BNP <500 pg/ml and Troponin <1.0 mcg/L), not requiring ventilatory support in the form of non-invasive ventilation (NIV), will be approached for recruitment. In-hospital patient management will be left to the discretion of the admitting physician, and will follow the new AHS admission order sets for AECOPD, which are based on current guidelines1. Dr Bhutani assisted in the development of these order sets. The order sets standardize pharmacological and non-pharmacological management of AECOPD; however, variance in patients need and time to delivery of these interventions will be present. Treatment will not be otherwise altered during this study, except the timing of the administration of short acting bronchodilators as it relates to the measurement of arterial stiffness and vascular function. 24 hours after recruitment, the research team will begin collecting patient/clinical treatment information on a daily basis (see Appendix B for list). 48 hours after admission, patients will be given an activity monitor to quantify daily physical activity. On the same day, vascular assessment through the measurement of pulse wave velocity, vascular function, lung function as well as serum markers of systemic inflammation (TNF-alpha, MMP-2, IL-6 and CRP) and exhaled nitric oxide (eNO), will be collected (this is in addition to usual blood work required for patient management). This will be repeated on days 5, 10, day of discharge and day 14 post discharge. Self efficacy and a 6-minute walk test will be performed on the day of discharge and on day 14 following discharge, while three-day physical activity will be determined at 14 days post discharge. BODE index will be determined at discharge and at 14 days post discharge (see Appendix C for data collection schedule).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
50 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Change in Inflammatory markers

时间窗: within 24 hours of Admission, within 24 hours of hospital discharge, 14 day follow up

CRP: C-reactive protein is a non-specific serum marker of inflammation (range \<8 is normal)

Change in Vascular Function

时间窗: Within 24 hours of Admission, within 24 hours of hospital discharge, 14 day follow up

Vascular Function assessed using EndoPat; RHI: Reactive Hyperemia Index

Change in Arterial Stiffness

时间窗: Within 24 hours of Admission, within 24 hours of hospital discharge, 14 day follow up

Pulse wave velocity assessed using Complior

次要结局

  • Readmission-All Cause(up to 1 year)
  • Readmission-AECOPD(up to 1 year)
  • Change in Physical Activity(Within 24 hours of Admission, within 24 hours of hospital discharge, 14 day follow up)
  • Change in Inflammatory marker (IL-6)(Within 24 hours of Admission, within 24 hours of hospital discharge, 14 day follow up)
  • Inflammatory marker (TNF-alpha)(14 days)
  • Length of Stay (LOS)(up to 30 days)
  • Inflammatory Marker (MMP-2)(14 days)
  • Quality of Life (QoL)(14 days)
  • Immunoglobulin Marker (IgM)(Within 24 hours of Admission)
  • Immunoglobulin Marker (IgG)(Within 24 hours of Admission)
  • Immunoglobulin Marker (IgA)(Within 24 hours of Admission)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Michael Stickland

Assistant Professor

University of Alberta

研究点 (1)

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