Ultrafiltration Profiling and Outcomes Among Individuals on Maintenance Hemodialysis
| Status: | Completed |
|---|---|
| Conditions: | Renal Impairment / Chronic Kidney Disease, Renal Impairment / Chronic Kidney Disease |
| Therapuetic Areas: | Nephrology / Urology |
| Healthy: | No |
| Age Range: | 18 - 85 |
| Updated: | 1/10/2019 |
| Start Date: | March 12, 2018 |
| End Date: | December 18, 2018 |
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.
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.
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
We found this trial at
2
sites
105 Renee Lynne Court
Carrboro, North Carolina 27510
Carrboro, North Carolina 27510
Principal Investigator: Jennifer Flythe, MD, MPH
Phone: 919-445-2686
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192 Campus Drive
Siler City, North Carolina 27344
Siler City, North Carolina 27344
Principal Investigator: Jennifer Flythe, MD, MPH
Phone: 919-445-2686
Click here to add this to my saved trials