CompletedNot Applicable

Enhancing the Cardiovascular Safety of Hemodialysis Care (Dialysafe)

United States1,431 participantsStarted 2023-01-11

Plain-language summary

The purpose of this study is reduce episodes of intradialytic hypotension, low blood pressure during a hemodialysis session, in patients with End Stage Renal Disease (ESRD). Recruitment will take place on the clinic level rather than the patient level.

Who can participate

Age range

21 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.

Selection is at both the clinic level and individual patient level. Clinic Inclusion Criteria: * outpatient hemodialysis facilities * at least 70 adult (\>21 years old) patients to guarantee sample size Clinic Exclusion Criteria: * facilities involved in another study * facilities in immediate jeopardy * facilities with 1-star quality ratings * facilities designated as COVID-19 isolation facilities Individual Patient Exclusion Criteria: * individual patients who are currently incarcerated * individual patients who have poor cognition or cognitive impairment * individual patients unable to comprehend the patient information sheet due to lack of facility in English or Spanish * individual patients who have opted out of data collection

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.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

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

Dialysis Session Stability

Timeframe: 24 weeks

Trial details

NCT IDNCT03171545

SponsorUniversity of Michigan

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-11-17

Results submitted2025-10-31

View on ClinicalTrials.gov More Kidney Failure trials

Who can participate

Age range

21 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.