Status:
COMPLETED
Ultrafiltration Profiling and Outcomes Among Individuals on Maintenance Hemodialysis
Lead Sponsor:
University of North Carolina, Chapel Hill
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
End Stage Renal Disease
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief Summary
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 as...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 12 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 18 2018
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT03301740
Start Date
March 12 2018
End Date
December 18 2018
Last Update
May 15 2020
Active Locations (2)
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1
Carolina Dialysis - Carrboro
Carrboro, North Carolina, United States, 27510
2
Carolina Dialysis - Siler City
Siler City, North Carolina, United States, 27344