Ultrafiltration Profiling and Outcomes Among Individuals on Maintenance Hemodialysis

University of North Carolina (UNC)

Status: Completed

Conditions: End Stage Renal Disease

Treatments: Other: UF profiling during HD; Other: Conventional HD

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03301740

17-1057

1K23DK109401 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 34 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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34 participants in 2 patient groups

UF Profiling Phase First

Experimental group

Description:

First treatment phase begins with linear UF profiling during HD. Participants randomized to starting with the experimental UF profiling phase will receive 9 HD treatments with UF profiling (1st experimental phase). Following a 3 conventional HD treatment wash-out period, participants will then cross over to 9 conventional HD treatments (1st control phase). Following a 2nd 3 conventional HD treatment wash-out period, participants will cross over to 9 HD treatments with UF profiling (2nd experimental phase). Following a 3rd conventional HD treatment wash-out period, participants will cross over to 9 conventional HD treatments (2nd control phase).

Treatment:

Other: Conventional HD

Other: UF profiling during HD

Conventional HD Phase First

Experimental group

Description:

First treatment phase begins with conventional HD. Participants randomized to starting with the control conventional HD phase will receive 9 conventional HD treatments (1st control phase). Following a 3 conventional HD treatment wash-out period, participants will then cross over to 9 HD treatments with UF profiling (1st experimental phase). Following a 2nd 3 conventional HD treatment wash-out period, participants will cross over to 9 conventional HD treatments (2nd control phase). Following a 3rd conventional HD treatment wash-out period, participants will cross over to 9 HD treatments with UF profiling (2nd experimental phase).

Treatment:

Other: Conventional HD

Other: UF profiling during HD