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Cardiovascular Safety Measures for Chronic Kidney Failure (Dialysafe Trial)

N/A

Waitlist Available

Led By Tiffany Veinot, PhD

Research Sponsored by University of Michigan

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

outpatient hemodialysis facilities

Be older than 18 years old

Must not have

individual patients who have poor cognition or cognitive impairment

individual patients who have opted out of data collection

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 52 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial is designed to reduce episodes of low blood pressure during hemodialysis in patients with End Stage Renal Disease.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this trial focuses on non-medical interventions like patient education and provider training, there are no direct medical side effects associated with drugs or procedures.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I receive my dialysis treatments at an outpatient center.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have difficulty thinking, remembering, or making decisions.

Select...

I have chosen not to share my medical data.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 52 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~52 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 52 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Dialysis Session Stability

Secondary study objectives

Dialysis adherence - minutes missed

Dialysis adherence - sessions missed

Fluid Adherence

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: Provider EducationExperimental Treatment1 Intervention

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

Group II: Patient and ProviderExperimental Treatment2 Interventions

This arm includes both Patient Activation and Provider Education interventions

Group III: Patient ActivationExperimental Treatment1 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 InterventionActive Control1 Intervention

Patients in clinic receive usual care.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Patient Activation

2009

N/A

~6210

Provider Education

2015