Ultrafiltration Profiling and Outcomes Among Individuals on Maintenance Hemodialysis
Completed · Not applicable
Conditions studied: End Stage Renal Disease
In brief
The rate of fluid removal (ultrafiltration, UF) during hemodialysis (HD) may contribute to cardiovascular morbidity and mortality among individuals receiving maintenance HD. More rapid UF rates are associated with higher morbidity and mortality. Ultrafiltration profiling, the practice of varying UF rates to maximize fluid removal during periods of greatest hydration and plasma oncotic pressures, is one treatment modification that may reduce UF-related harm without necessitating reduction in interdialytic fluid intake or longer HD treatments. To date, UF profiling has not been adequately studied independent of sodium profiling. This study investigates the comparative effect of UF profiling versus non-profiled conventional HD on select cardiovascular and patient-reported outcomes. Participants will complete two phases of UF profiling and two phases of conventional HD and will act as their own controls.
Key facts
- Study ID
- NCT03301740
- Run by
- University of North Carolina, Chapel Hill
- People needed
- 34
- Starts
- 2018-03-12
- Expected to finish
- 2018-12-18
- Last updated by the study team
- 2020-05-15
Who can join
Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- UF rate >10 mL/h/kg in >30% of treatments in a 30-day screening period (require ≥6 outpatient HD treatments in this period)
- Age 18-85 years
- Ability to converse comfortably in English or Spanish
- Receipt of in-center maintenance HD at Carolina Dialysis clinics in Carrboro or Siler City, North Carolina
- ≥90 days on HD
- Free of bloodstream infection during screening period
- Willingness to undergo all study testing
- Evidence of a signed and dated informed consent document
You may not qualify if…
- Systolic BP unable to be measured by arm cuff
- >1 hospitalization during screening period
- Unstable angina per treating nephrologist
- End-stage cirrhosis per treating nephrologist
- New York Heart Association class IV heart failure per treating nephrologist
- Pregnant
- More than 4 times per week HD
- Incarcerated
- Anticipated kidney transplant within 6 months per treating nephrologist
- Non-adherence to HD prescription (>2 unexplained absences during screening period)
- Sodium profiling or UF profiling in standard HD prescription
- Decisionally challenged, unable to provide informed consent
Where it is running
- Carolina Dialysis - Carrboro — Carrboro, North Carolina, United States
- Carolina Dialysis - Siler City — Siler City, North Carolina, United States
Full record on ClinicalTrials.gov
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