N/A
Completed N=1,431
Enhancing the Cardiovascular Safety of Hemodialysis Care (Dialysafe)
Source: ClinicalTrials.gov NCT03171545 ↗Enrolled (actual)
1,431
Serious AEs
0.0%
Results posted
Jan 2026
Primary outcomePrimary: Dialysis Session Stability — 0.202; 0.199; 0.172; 0.182 Proportion of sessions
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.
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 | — |
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. Informational only — not medical advice.