N/A
N=1,431
Enhancing the Cardiovascular Safety of Hemodialysis Care (Dialysafe)
Kidney Failure · End Stage Renal Disease · Hypotension · Cardiovascular Diseases · Patient Safety
Bottom Line
View on ClinicalTrials.gov: NCT03171545 ↗Enrolled (actual)
1,431
Serious AEs
0.0%
Results posted
Jan 2026
Primary outcome: Primary: Dialysis Session Stability — 0.202; 0.199; 0.172; 0.182 Proportion of sessions
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Patient Activation (Behavioral); Provider Education (Behavioral)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- University of Michigan
- Primary completion
- Nov 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Dialysis Session Stability |
0.202; 0.199; 0.172; 0.182 | — |
| SECONDARY Fluid Adherence |
2.12; 2.18; 2.35; 2.34 | — |
| SECONDARY Dialysis Adherence - Average Weekly Minutes Missed Over Intervention Period |
5.23; 4.21; 5.28; 4.89 | — |
| SECONDARY Dialysis Adherence - Average Weekly Sessions Missed During Intervention Period |
0.004; 0.008; 0.028; 0.032 | — |
| SECONDARY Patient Symptoms - Post-dialysis Recovery Time |
0.141; 0.181; 0.178; 0.158 | — |
| SECONDARY Patient Symptoms - Symptom Burden |
0.045; 0.069; 0.051; 0.063 | — |
| SECONDARY Quality of Life-KDQOL - MCS |
53.85; 52.62; 54.58; 54.89 | — |
| SECONDARY Quality of Life-KDQOL - PCS |
35.98; 38.01; 39.49; 36.18 | — |
| SECONDARY Hospitalization |
1.55; 1.15; 1.37; 1.23 | — |
| SECONDARY Mortality |
16.99; 9.30; 14.85; 10.44 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03171545). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.