CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 34 enrolled
Drug / intervention
UF profiling during HD +1 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03301740
NCT03301740N/ACompleted

Ultrafiltration Profiling and Outcomes Among Individuals on Maintenance Hemodialysis

University of North Carolina, Chapel Hill·interventional·Posted Oct 4, 2017·Updated May 15, 2020

In Brief

A clinical study evaluating UF profiling during HD and Conventional HD for End Stage Renal Disease. Completed, enrolled 34 participants across 2 sites.

Detailed 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 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedOct 4, 2017
Enrollment StartMar 12, 2018
Primary CompletionDec 15, 2018
Study CompletionDec 18, 2018
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 8.7 years ago

Interventions

UF profiling during HDother

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 HDother

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