Abstract: TH-PO1192
A Randomized Crossover Trial of Ultrafiltration (UF)-Profiled Hemodialysis (HD) for UF Rate-Related Harm
Session Information
- Late-Breaking Clinical Trials Posters
November 07, 2019 | Location: Exhibit Hall, Walter E. Washington Convention Center
Abstract Time: 10:00 AM - 12:00 PM
Category: Dialysis
- No subcategory defined
Authors
- Flythe, Jennifer E., University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States
- Tugman, Matthew James, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States
- Narendra, Julia, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States
- Assimon, Magdalene M., University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States
- Li, Quefeng, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States
- Wang, Yueting, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States
- Brunelli, Steven M., DaVita Clinical Research, Needham, Massachusetts, United States
- Hinderliter, Alan L., University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States
Background
Rapid UF is associated with adverse outcomes among HD patients. UF profiling, the practice of varying UF rates to maximize fluid removal during periods of greatest hydration and oncotic pressure, may reduce UF rate-related complications.
Methods
In this 4-phase, blinded crossover trial, participants (UF rates >10 mL/h/kg in ≥30% of screening treatments) were assigned in random order to receive HD with conventional UF vs. UF-profiled HD; each 3-wk treatment period was followed by a 1-wk washout period. Participants crossed into each treatment arm twice (2 phases/arm). Each patient was their own control. The primary outcomes were intradialytic hypotension (IDH, nadir systolic BP <90mmHg), rise in serum troponin T from pre- to post-HD (≥10%), and change in left ventricular global longitudinal strain (GLS) from baseline to peak intra-HD stress (%). Secondary outcomes included intra-HD symptoms and blood volume monitor-measured plasma refill (hematocrit fall by ≥0.5%), a volume status measure.
Results
On average, the 34 randomized patients (mean age 56y, 24% female, mean HD vintage 6.3y) had UF rates ≥10 mL/h/kg in 56% treatments during the 4-wk screening period. All but 2 patients completed the 15-wk study (long hospitalization, transplant). With UF-profiled HD, patients had significantly lower odds of light-headedness and plasma refill (i.e. less post-HD hypervolemia) compared to HD with conventional UF. There was no significant difference in IDH. There was a non-significant trend toward a lower odds of troponin T rise with UF-profiled HD.
Conclusion
UF-profiled HD did not reduce the odds of IDH or troponin T rise but did reduce the odds of light-headedness and post-HD plasma refill.
Selected outcomes
Outcome | Odds ratio (95% confidence interval), UF-profiled HD vs. conventional HD* |
Intradialytic hypotension | 1.2 (0.8, 1.7) |
Troponin T rise (%) | 0.5 (0.2, 1.3) |
Left ventricular GLS change (%) | Results pending |
Cramping | 0.9 (0.4, 2.1) |
Light-headedness | 0.2 (0.06, 0.9)** |
Plasma refill | |
0.2 (0.05, 0.9)** |
* Difference of outcomes between the UF-profiled intervention arm and the conventional UF control arm were assessed with likelihood ratio tests using various generalized linear mixed models depending on outcome type. ** p<0.05.
Funding
- NIDDK Support