Multimodal Assessment of Dyspnea, Cardiopulmonary Structure and Function in Chronic Hemodialysis Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Baseline Modified Medical Research Council scale score.
研究概览
简要总结
Shortness of breath is very common among patients on dialysis for kidney failure; however, its causes are often not understood. This study will explore the lungs and the heart of these patients to determine the causes of shortness of breath. The amount of salt in the body tissues, which tends to accumulate in dialysis patients and can also cause shortness of breath, will also be measured. Machines that exploit magnetic resonance, ultrasound and x-rays to take images of the body interior will be employed; in addition, breathing tests, questionnaires and blood tests will also be used. 20 patients on dialysis will be recruited and have two visits: one at the beginning of the study and one year later to observe any changes in the lungs, heart and salt accumulation over time.
详细描述
Rationale:
The available evidence suggest that End-Stage Renal Disease (ESRD) and hemodialysis (HD) have harmful effects on the lungs; the investigators hypothesize that these recurring pulmonary insults, in an analogous way as recurring myocardial ischemic injury for the heart, cause long term impairment in the pulmonary parenchyma, airways and circulation. In addition, observational studies have reported that dyspnea is a common symptom among ESRD patients on chronic HD treatment; however, no study up to now has directly addressed the issue, so that the relationship between dyspnea and pulmonary involvement in the HD population remains poorly understood.
The aim of this study is to explore the pathophysiological basis of dyspnea in patients with end stage renal disease on chronic HD, by using state-of-the-art imaging and functional study techniques.
Study Design:
This is an exploratory study involving a single center recruiting patients from the prevalent dialysis population of London, Ontario. 20 patients on maintenance hemodialysis will be recruited. The patients will undergo imaging, functional studies and blood sampling at the Robarts Research Institute on a non-dialysis day, during the short interval in the dialysis schedule, at baseline and after one year.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age equal to or greater than 18 years.
- •Dialysis vintage equal to or greater than 3 months.
- •Exclusion Criteria
- •Smoking history of more than 10 packs/year.
- •Active tobacco and/or cannabis smoking.
- •Diagnosed chronic pulmonary disease.
- •Severe heart failure (NYHA class IV)
- •Active infection (including tuberculosis) or malignancy.
- •Pregnancy.
- •Inability to give consent or understand written information.
- •Peripheral oxygen saturation (by pulse oxymetry) dropping below 80% when performing a 12-seconds breathhold.
- •Inability to perform spirometry or plethysmography maneuvers.
- •Inability to tolerate MRI due to patient size and/or known history of claustrophobia.
- •Subject has an implanted mechanically, electrically or magnetically activated device or any metal in their body which cannot be removed, including but not limited to pacemakers, neurostimulators, biostimulators, implanted insulin pumps, aneurysm clips, bioprosthesis, artificial limb, metallic fragment or foreign body, shunt, surgical staples (including clips or metallic sutures and/or ear implants.).
排除标准
- 未提供
结局指标
主要结局
Baseline Modified Medical Research Council scale score.
时间窗: Baseline
Baseline dyspnea measured by Modified Medical Research Council scale. 0-4 from lowest (no dyspnea) to highest (most severe dyspnea).
Baseline University of California, San Diego Shortness of Breath Questionnaire score.
时间窗: Baseline
Baseline dyspnea measured by University of California, San Diego Shortness of Breath Questionnaire. 0-120 from lowest (no dyspnea) to highest (most severe dyspnea).
Baseline pulmonary artery diameter.
时间窗: Baseline
Baseline pulmonary artery diameter (in millimeters) by chest Computed Tomography.
Baseline lung low attenuation area.
时间窗: Baseline
Baseline lung low attenuation area by chest Computed Tomography.
Baseline lung water content.
时间窗: Baseline
Baseline lung water content in arbitrary units measured by proton Magnetic Resonance Imaging.
Baseline lung total blood vessel volume.
时间窗: Baseline
Baseline lung total blood vessel volume in ml by chest Computed Tomography.
Baseline lung total airway count.
时间窗: Baseline
Baseline lung total airway count by chest Computed Tomography.
Baseline soft tissue sodium content.
时间窗: Baseline
Baseline soft tissue sodium content in mmol/L measured by sodium Magnetic Resonance Imaging.
次要结局
- One year changes in Modified Medical Research Council scale score.(Baseline and one year)
- Correlation between baseline modified Medical Research Council scale score and one year mortality.(Baseline and one year)
- Correlation between modified Medical Research Council scale score and soft tissue sodium content.(Baseline and one year)
- Correlation between baseline modified Medical Research Council scale score and one year morbidity.(Baseline and one year)
- Correlation between modified Medical Research Council scale score and lung total airway count.(Baseline and one year)
- Correlation between modified Medical Research Council scale score and lung low attenuation areas.(Baseline and one year)
- Correlation between modified Medical Research Council scale score and pulmonary artery diameter.(Baseline and one year)
- Correlation between modified Medical Research Council scale score and lung total water content.(Baseline and one year)
- Correlation between baseline University of California, San Diego Shortness of Breath Questionnaire score and one year morbidity.(Baseline and one year)
- Correlation between baseline University of California, San Diego Shortness of Breath Questionnaire score and one year mortality.(Baseline and one year)
- Correlation between modified Medical Research Council scale score and lung total blood vessel volume.(Baseline and one year)
- One year changes in University of California, San Diego Shortness of Breath Questionnaire score.(Baseline and one year)
- Correlation between University of California, San Diego Shortness of Breath Questionnaire score and soft tissue sodium content.(Baseline and one year)
- Correlation between University of California, San Diego Shortness of Breath Questionnaire score and pulmonary artery diameter.(Baseline and one year)
- Correlation between University of California, San Diego Shortness of Breath Questionnaire score and lung total airway count.(Baseline and one year)
- Correlation between University of California, San Diego Shortness of Breath Questionnaire score and lung low attenuation areas.(Baseline and one year)
- Correlation between University of California, San Diego Shortness of Breath Questionnaire score and lung total blood vessel volume.(Baseline and one year)
- Correlation between University of California, San Diego Shortness of Breath Questionnaire score and lung total water content.(Baseline and one year)
- One year changes in lung total blood vessel volume.(Baseline and one year)
- One year changes in lung low attenuation areas.(Baseline and one year)
- One year changes in fractional exhaled nitric oxide.(Baseline and one year)
- One year changes in lung total airway count.(Baseline and one year)
- One year changes in lung water content.(Baseline and one year)
- Baseline pulmonary artery systolic pressure.(Baseline)
- One year changes in pulmonary artery systolic pressure.(Baseline and one year)
- Baseline forced expiratory volume at one second/forced vital capacity ratio.(Baseline)
- One year changes in pulmonary artery diameter.(Baseline and one year)
- One year changes in forced expiratory volume at one second/forced vital capacity ratio.(Baseline and one year)
- Baseline fractional exhaled nitric oxide.(Baseline)
- Baseline diffusing capacity of the lung for carbon monoxide.(Baseline)
- One year changes in diffusing capacity of the lung for carbon monoxide.(Baseline and one year)
- Baseline six minute walk distance.(Baseline)
- One year changes in six minute walk distance.(Baseline and one year)
- One year changes in soft tissue sodium content.(Baseline and one year)
研究者
Chris McIntyre
Professor of Medicine, Medical Biophysics and Paediatrics, University of Western Ontario. Director of The Lilibeth Caberto Kidney Clinical Research Unit, London Health Sciences Centre.
Lawson Health Research Institute