CompletedNot Applicable

Dyspnea Assessment in Hemodialysis Patients

Canada7 participantsStarted 2019-03-29

Plain-language summary

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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.).

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This study measured soft tissue sodium content alongside breathing difficulty in hemodialysis patients — has my care team looked at whether sodium buildup might be contributing to my shortness of breath?
2The trial tracked several lung measurements like airway count, low-attenuation areas, and lung water content using what sounds like imaging — would any of those tests be relevant or available for evaluating my own breathing symptoms?
3Since this study is completed, would it be worth asking if the findings changed how dyspnea is assessed or managed in hemodialysis patients at your practice?
4The trial used two different breathlessness questionnaires — the UCSD Shortness of Breath Questionnaire and the Modified MRC scale — could we use one of those tools to get a clearer picture of how severe my dyspnea actually is?
5This study looked at patients with a mix of conditions including chronic heart disease, chronic lung disease, and end-stage renal disease — given my specific situation, which of those factors does my doctor think is most responsible for my breathing difficulty?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Baseline Modified Medical Research Council scale score.

Timeframe: Baseline

Baseline University of California, San Diego Shortness of Breath Questionnaire score.

Timeframe: Baseline

Baseline pulmonary artery diameter.

Timeframe: Baseline

Baseline lung total blood vessel volume.

Timeframe: Baseline

Baseline lung total airway count.

Timeframe: Baseline

Baseline lung low attenuation area.

Timeframe: Baseline

Baseline lung water content.

Timeframe: Baseline

Baseline soft tissue sodium content.

Trial details

NCT IDNCT03773991

SponsorLondon Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2020-02-25

View on ClinicalTrials.gov More Dyspnea; Uremic trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Baseline Modified Medical Research Council scale score.

Timeframe: Baseline

Baseline University of California, San Diego Shortness of Breath Questionnaire score.

Timeframe: Baseline

Baseline pulmonary artery diameter.

Timeframe: Baseline

Baseline lung total blood vessel volume.

Timeframe: Baseline

Baseline lung total airway count.

Timeframe: Baseline

Baseline lung low attenuation area.

Timeframe: Baseline

Baseline lung water content.

Timeframe: Baseline

Baseline soft tissue sodium content.