New fluid management approach for hemodialysis patients
Using Intradialytic Blood Pressure Slopes to Guide Ultrafiltration in Hemodialysis Patients
This study tests a new way to manage fluid in hemodialysis patients to see if it can help keep their blood pressure stable and reduce the risk of dangerously low blood pressure during treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 69 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | VA Office of Research and Development Federal |
| Locations | 1 site (Dallas, Texas) |
| Trial ID | NCT04163614 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to improve fluid management in hemodialysis patients by utilizing a novel, patient-specific ultrafiltration algorithm based on recent blood pressure patterns. The study compares this new approach to standard care, focusing on the overall change in blood pressure between dialysis sessions and the frequency of dangerously low blood pressure episodes during treatment. The goal is to address the challenges of extracellular volume overload and minimize the risk of intradialytic hypotension, which are significant contributors to high mortality rates in this population. By employing bioimpedance spectroscopy, the trial seeks to provide a more precise method for fluid removal that could enhance patient outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are hemodialysis patients with elevated blood pressure levels.
Not a fit: Patients with severe blood pressure instability or those who do not meet the inclusion criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce mortality and hospitalization rates among hemodialysis patients by improving fluid management.
How similar studies have performed: While there is limited data on the specific use of bioimpedance spectroscopy in routine practice, similar approaches to fluid management have shown promise in improving patient outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Hemodialysis patient * Pre-dialysis systolic blood pressure greater than 140 mmHg averaged over 2 weeks OR post-dialysis systolic blood pressure greater than 130 mmHg averaged over 2 weeks Exclusion Criteria: * HemoDialysis Vintage Less than 2 months * Pregnancy * Mean systolic blood pressure nadir \<95 mmHg in 2 weeks screening * Mean pre- or post-dialysis systolic blood pressure \>180 mmHg * Mean pre to post-HD decrease in blood pressure \>60 mmHg * Routine intradialytic clonidine use * Routine intradialytic midodrine use * Documented antihypertensive medication non-adherence * Mean ultrafiltration rate \>13 mL/kg/hr during 2 week screening * For bioimpedance measurements only: amputation of a major extremity, presence of cardiac defibrillator or pacemaker, presence of a metallic implant (prosthetic joint)
Where this trial is running
Dallas, Texas
- VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX — Dallas, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Peter Noel Van Buren, MD — VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX
- Study coordinator: Peter N Van Buren, MD
- Email: peter.vanburen@va.gov
- Phone: (214) 857-2214
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.