Abstract: TH-PO1169
Effect of Hemodiafiltration (HDFIT) on Physical Activity and Self-Reported Outcomes: Primary Results of the Brazilian HDFIT Trial
Session Information
- Late-Breaking Clinical Trials Posters
October 25, 2018 | Location: Exhibit Hall, San Diego Convention Center
Abstract Time: 10:00 AM - 12:00 PM
Category: Dialysis
- No subcategory defined
Authors
- Pecoits-Filho, Roberto, Pontificia Universidade Catolica do Parana, Curitiba, PR, Brazil
- Larkin, John W., Pontificia Universidade Catolica do Parana, Curitiba, PR, Brazil
- Gonçalves, Priscila Bezerra, Pontificia Universidade Catolica do Parana, Curitiba, PR, Brazil
- Sheth, Shimul, Renal Research Institute, New York, New York, United States
- Han, Hao, Fresenius Medical Care North America, Waltham, Massachusetts, United States
- Poli de Figueiredo, Carlos Eduardo, Pontificia Universidade Catolica do Rio Grande do Sul, Porto Alegre, RS, Brazil
- Cuvello neto, Americo Lourenço, Hospital Alemão Oswaldo Cruz, Sao Paulo, Brazil
- Barra, Ana Beatriz Lesqueves, Fresenius Medical Care, Rio de Janeiro, Brazil
- Raimann, Jochen G., Renal Research Institute, New York, New York, United States
- Canziani, Maria Eugenia F., Universidade Federal de Sao Paulo, Sao Paulo, SP, Brazil
Group or Team Name
- HDFIT Study Investigators
Background
Advantages of hemodiafiltration (HDF) in solute removal and clinical outcomes compared to hemodialysis have been reported. HDFIT investigated the effects of HDF on physical activity (PA), quality of life (QOL) and other outcomes.
Methods
HDFIT (NCT02787161) is a multicenter RCT conducted in 13 clinics in Brazil that studied if HDF effects PA measured by accelerometry (ActiGraph, Pensacola, USA), self-reported QOL as per SF-36, and laboratories. Stable HD patients (vintage 3-24 months) were randomized to either high-volume online HDF or high-flux HD (control). We compared differences in changes from baseline (BL) at months 3 and 6 for 1) step counts and moderate-to-vigorous PA (MVPA) over 24 hrs after HD (primary outcome) and 2) self-reported SF-36 vitality scores and post-dialysis recovery time (secondary outcome), and 3) laboratory parameters. Linear mixed-effects models (LMM; adjusted for age, sex, and baseline values) quantified effect sizes of switching to HDF. Data are reported as percentage of the effect size to the BL mean value (control) with 95% CIs.
Results
We randomized 195 patients (age 53±15 yrs; 71% male; 29% diabetes) from Aug/16 to Oct/17. Exchangeability at BL was achieved for the primary outcomes (BL step count 5184±3374 (HDF) vs 5050±4262 (HD), P=0.69; min of MVPA 27±32 (HDF) vs 27±42 (HD), P=0.95). HDF tended to increase the step count by 3.0% (95%CI -2.3 to 8.3) and the min of MVPA by 2.3% (95%CI -6.9 to 11.5; Figure 1A), and reduce the recovery time by 15% (-31 to 2) vs HD (Figure 1B). SF-36 Vitality scores were not affected by HDF. Effect sizes of HDF on laboratories are consistent with increased solute clearance (Figure 1C).
Conclusion
HDF produces higher clearance of solutes compared to HD. Despite borderline significance, HDF has a positive absolute effect on increasing step counts and minutes of MVPA, and reducing post-dialysis recovery time compared to HD.
Funding
- Commercial Support – Fresenius Medical Care and Pontificia Universidade Catolica do Parana