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 range21 Years

SexALL

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

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

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