Dyspnea Assessment in Hemodialysis Patients
Λέξεις-κλειδιά
Αφηρημένη
Περιγραφή
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.
Study Procedures:
Blood Collection: blood will be collected from a venous access for standard-of-care tests, uremia and inflammation biomarkers.
Dyspnea Assessment: dyspnea will be assessed with the following self-administered questionnaires: Modified Medical Research Council Breathlessness Scale, the University of California, San Diego Shortness of Breath Questionnaire Pulmonary Function Tests: spirometry and plethysmography pre and post salbutamol administration, carbon monoxide diffusion (DLCO) and the fractional exhaled nitric oxide (FeNO) will be evaluated.
Six Minute Walk Test: the subjects able to do so will perform a six minute walk test, their dyspnea and overall fatigue at baseline and at the end of the exercise will be evaluated using the Borg Scale.
Lung MRI: a proton MRI with ultrashort echo time (UTE) acquisition sequences for the study of lung parenchyma and lung water will be employed. Images will be acquired twice, both pre and post a bronchodilator (salbutamol) challenge.
Sodium MRI: a proton T1 weighted fast-low-angle-shot (FLASH)- sequence will be acquired to delineate the anatomy of the lower leg. Then, a sodium MRI study of the subjects' legs (~5 cm below the knee) will be obtained with the custom-made sodium coil at 3.0 Tesla.
Water content will also be quantified using proton-MRI with fat-suppressed inversion recovery sequence with proton density contrast.
Chest CT: a high-resolution chest CT scan will be performed using a 64-slice CT scanner. A low radiation dose protocol will be employed. A qualitative and quantitative evaluation of pulmonary airways, blood vessels and parenchyma will be performed.
2D Transthoracic Echocardiography: images will be taken in the left lateral decubitus. Images and loops from standard parasternal long axis and short axis, subcostal, apical 4, 2 and 3- chamber views will be recorded and analyzed for: global longitudinal strain, left ventricular ejection fraction, left ventricular mass, left atrial volume, right ventricular diameter, right atrial volume, right ventricular wall thickness, tricuspid annular plane systolic excursion, pulmonary artery systolic pressure, E/A ratio, E/E' ratio at the basal interventricular septum, aortic, mitral, tricuspid and pulmonary valve qualitative and quantitative function.
Ημερομηνίες
| Τελευταία επαλήθευση: | 09/30/2019 |
| Πρώτα υποβλήθηκε: | 11/28/2018 |
| Υποβλήθηκε εκτιμώμενη εγγραφή: | 12/09/2018 |
| Δημοσιεύτηκε για πρώτη φορά: | 12/11/2018 |
| Υποβλήθηκε τελευταία ενημέρωση: | 10/01/2019 |
| Δημοσιεύτηκε η τελευταία ενημέρωση: | 10/03/2019 |
| Ημερομηνία έναρξης της πραγματικής μελέτης: | 03/28/2019 |
| Εκτιμώμενη κύρια ημερομηνία ολοκλήρωσης: | 11/30/2020 |
| Εκτιμώμενη ημερομηνία ολοκλήρωσης μελέτης: | 11/30/2020 |
Κατάσταση ή ασθένεια
Παρέμβαση / θεραπεία
Diagnostic Test: Maintenance Hemodialysis Patients
Diagnostic Test: Maintenance Hemodialysis Patients
Diagnostic Test: Maintenance Hemodialysis Patients
Diagnostic Test: Maintenance Hemodialysis Patients
Diagnostic Test: Maintenance Hemodialysis Patients
Diagnostic Test: Maintenance Hemodialysis Patients
Diagnostic Test: Maintenance Hemodialysis Patients
Diagnostic Test: Maintenance Hemodialysis Patients
Diagnostic Test: Maintenance Hemodialysis Patients
Φάση
Ομάδες βραχιόνων
| Μπράτσο | Παρέμβαση / θεραπεία |
|---|---|
| Maintenance Hemodialysis Patients Patients on chronic hemodialysis therapy due to end-stage renal disease.
Proton Lung MRI
Sodium MRI of the leg
Chest CT
Transthoracic Echocardiography
Fractional Exhaled Nitric Oxide
Six-Minute Walk Test
Pulmonary Function Tests
Blood sampling
Self-administered dyspnea questionnaires | Diagnostic Test: Maintenance Hemodialysis Patients Proton Lung Magnetic Resonance Imaging |
Κριτήρια καταλληλότητας
| Επιλέξιμες ηλικίες για μελέτη | 18 Years Προς την 18 Years |
| Φύλα επιλέξιμα για μελέτη | All |
| Μέθοδος δειγματοληψίας | Non-Probability Sample |
| Δέχεται υγιείς εθελοντές | Ναί |
| Κριτήρια | Inclusion Criteria: - 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.). |
Αποτέλεσμα
Πρωτεύοντα αποτελέσματα
1. Baseline Modified Medical Research Council scale score. [Baseline]
2. Baseline University of California, San Diego Shortness of Breath Questionnaire score. [Baseline]
3. Baseline pulmonary artery diameter. [Baseline]
4. Baseline lung total blood vessel volume. [Baseline]
5. Baseline lung total airway count. [Baseline]
6. Baseline lung low attenuation area. [Baseline]
7. Baseline lung water content. [Baseline]
8. Baseline soft tissue sodium content. [Baseline]
Δευτερεύοντα αποτελέσματα
1. One year changes in Modified Medical Research Council scale score. [Baseline and one year]
2. Correlation between baseline modified Medical Research Council scale score and one year morbidity. [Baseline and one year]
3. Correlation between baseline modified Medical Research Council scale score and one year mortality. [Baseline and one year]
4. Correlation between modified Medical Research Council scale score and soft tissue sodium content. [Baseline and one year]
5. Correlation between modified Medical Research Council scale score and pulmonary artery diameter. [Baseline and one year]
6. Correlation between modified Medical Research Council scale score and lung total blood vessel volume. [Baseline and one year]
7. Correlation between modified Medical Research Council scale score and lung total airway count. [Baseline and one year]
8. Correlation between modified Medical Research Council scale score and lung low attenuation areas. [Baseline and one year]
9. Correlation between modified Medical Research Council scale score and lung total water content. [Baseline and one year]
10. One year changes in University of California, San Diego Shortness of Breath Questionnaire score. [Baseline and one year]
11. Correlation between baseline University of California, San Diego Shortness of Breath Questionnaire score and one year morbidity. [Baseline and one year]
12. Correlation between baseline University of California, San Diego Shortness of Breath Questionnaire score and one year mortality. [Baseline and one year]
13. Correlation between University of California, San Diego Shortness of Breath Questionnaire score and pulmonary artery diameter. [Baseline and one year]
14. Correlation between University of California, San Diego Shortness of Breath Questionnaire score and soft tissue sodium content. [Baseline and one year]
15. Correlation between University of California, San Diego Shortness of Breath Questionnaire score and lung total blood vessel volume. [Baseline and one year]
16. Correlation between University of California, San Diego Shortness of Breath Questionnaire score and lung total airway count. [Baseline and one year]
17. Correlation between University of California, San Diego Shortness of Breath Questionnaire score and lung low attenuation areas. [Baseline and one year]
18. Correlation between University of California, San Diego Shortness of Breath Questionnaire score and lung total water content. [Baseline and one year]
19. One year changes in lung total blood vessel volume. [Baseline and one year]
20. One year changes in lung total airway count. [Baseline and one year]
21. One year changes in lung water content. [Baseline and one year]
22. One year changes in lung low attenuation areas. [Baseline and one year]
23. One year changes in pulmonary artery diameter. [Baseline and one year]
24. Baseline pulmonary artery systolic pressure. [Baseline]
25. One year changes in pulmonary artery systolic pressure. [Baseline and one year]
26. Baseline fractional exhaled nitric oxide. [Baseline]
27. One year changes in fractional exhaled nitric oxide. [Baseline and one year]
28. Baseline forced expiratory volume at one second/forced vital capacity ratio. [Baseline]
29. One year changes in forced expiratory volume at one second/forced vital capacity ratio. [Baseline and one year]
30. Baseline diffusing capacity of the lung for carbon monoxide. [Baseline]
31. One year changes in diffusing capacity of the lung for carbon monoxide. [Baseline and one year]
32. Baseline six minute walk distance. [Baseline]
33. One year changes in six minute walk distance. [Baseline and one year]
34. One year changes in soft tissue sodium content. [Baseline and one year]
