Cardiovascular Safety Measures for Chronic Kidney Failure

(Dialysafe Trial)

Overseen By Rajiv Saran, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Michigan

Disqualifiers: Incarceration, Cognitive impairment, Language barrier, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

1431 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Tiffany Veinot, PhD

Principal Investigator

University of Michigan

Eligibility Criteria

This trial is for adult patients with End Stage Renal Disease who are undergoing outpatient hemodialysis. Facilities must have at least 70 such patients and not be rated as poor quality, involved in other studies, designated COVID-19 isolation centers, or in immediate jeopardy.

Inclusion Criteria

I receive my dialysis treatments at an outpatient center.

I am over 21 years old.

Exclusion Criteria

individual patients unable to comprehend the patient information sheet due to lack of facility in English or Spanish

I have difficulty thinking, remembering, or making decisions.

You are currently in prison.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Implementation of multimodal provider education and patient activation interventions to improve dialysis session stability

48 weeks

Regular dialysis sessions, 3 times a week

Follow-up

Participants are monitored for safety and effectiveness after the intervention period

4 weeks

Treatment Details

Interventions

• Patient Activation
• Provider Education

Trial Overview The Dialysafe study aims to reduce low blood pressure episodes during hemodialysis by implementing patient activation strategies and educating healthcare providers at the clinic level.

Participant Groups

Group I: Provider Education Experimental Treatment 1 Intervention

This arm focuses on dialysis facility care teams. It includes team training, online education, and checklists.

Group II: Patient and Provider Experimental Treatment 2 Interventions

This arm includes both Patient Activation and Provider Education interventions

Group III: Patient Activation Experimental Treatment 1 Intervention

This arm focuses on patients. It includes peer mentoring by trained End Stage Renal Disease (ESRD) patients. Mentors will hold 5 multimedia-aided meetings with other patients that include motivational interviewing and role modeling.

Group IV: No Intervention Active Control 1 Intervention

Patients in clinic receive usual care.

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

National Kidney Foundation, United States

Collaborator

National Kidney Foundation

Collaborator

National Kidney Foundation

Collaborator

Trials

33

Recruited

85,800+

University of California, Irvine

Collaborator

Trials

580

Recruited

4,943,000+

Fresenius Medical Care North America

Industry Sponsor

Trials

40

Recruited

78,400+