Ultrafiltration Profiling and Outcomes Among Individuals on Maintenance Hemodialysis

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-12

Study Completion Date

2018-12-18

Brief Summary

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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.

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Detailed Description

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Conditions

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End Stage Renal Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

The study is a 4-phase crossover trial in which participants are successively alternated between conventional HD and conventional HD + linear UF profiling across 4 phases with intervening wash-out periods. The study compares conventional HD (the participant's standard HD prescription with no UF profiling) to conventional HD + linear UF profiling. Participants will be randomly allocated to conventional HD or conventional HD + linear UF profiling for phase 1. Participants will undergo 9 treatments during each phase for a total of 18 conventional HD treatments and 18 UF profiled treatments. Participants will undergo 3 wash-out HD treatments between phases.

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

The study will be double-blinded in that participants will not be informed of the treatment paradigm. Investigators, including those performing transthoracic echocardiography (TTE) interpretation, will be blinded to treatment paradigm. Ultrasonographers performing intra-HD TTEs will be blinded to treatment paradigm.

Study Groups

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UF Profiling Phase First

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).

Group Type EXPERIMENTAL

UF profiling during HD

Intervention Type OTHER

Experimental arm: Linear UF profiling (linearly decreasing UF rate with a UF rate starting at 1.33 times the rate that would be needed at a constant UF rate to achieve the desired post-weight; pre-programmed "profile 2" on a Fresenius 2008K machine, the machine used in all participating clinics). Ultrafiltration profiling will be performed using Fresenius 2008K dialysis machines in accordance with manufacturer instructions.

Conventional HD

Intervention Type OTHER

Control arm: Conventional HD (routine care) is the participant's standard HD prescription without UF profiling.

Conventional HD Phase First

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).

Group Type EXPERIMENTAL

UF profiling during HD

Intervention Type OTHER

Experimental arm: Linear UF profiling (linearly decreasing UF rate with a UF rate starting at 1.33 times the rate that would be needed at a constant UF rate to achieve the desired post-weight; pre-programmed "profile 2" on a Fresenius 2008K machine, the machine used in all participating clinics). Ultrafiltration profiling will be performed using Fresenius 2008K dialysis machines in accordance with manufacturer instructions.

Conventional HD

Intervention Type OTHER

Control arm: Conventional HD (routine care) is the participant's standard HD prescription without UF profiling.

Interventions

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UF profiling during HD

Experimental arm: Linear UF profiling (linearly decreasing UF rate with a UF rate starting at 1.33 times the rate that would be needed at a constant UF rate to achieve the desired post-weight; pre-programmed "profile 2" on a Fresenius 2008K machine, the machine used in all participating clinics). Ultrafiltration profiling will be performed using Fresenius 2008K dialysis machines in accordance with manufacturer instructions.

Intervention Type OTHER

Conventional HD

Control arm: Conventional HD (routine care) is the participant's standard HD prescription without UF profiling.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No