Clinical trial NCT02787161: Impact of HemoDiaFIltration on Physical Activity and Self- Reported Outcomes
Official title: Impact of HemoDiaFIltration on Physical Activity and Self-reported Outcomes: a Randomized Controlled Trial (HD-FIT Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Kidney Disease
Keywords: Chronic Kidney Disease
Hemodialysis
Hemodiafiltration
Renal Replacement Therapy
Physical Activity
Accelerometer
Lead sponsor: Pontifícia Universidade Católica do Paraná
Sponsor class: OTHER
Collaborators: name: Fresenius AG
First posted: 2016-06-01
Enrollment: 195
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomized controlled clinical trial that will analyze the impact of high volume online HDF in comparison to high-flux HD on measured physical activity.

Detailed description: HD-FIT is a randomized controlled clinical trial that will analyze the impact of high volume online HDF in comparison to high-flux HD on measured physical activity (number of steps measured in the dialysis day) as a primary endpoint. The analysis of additional accelerometer data, HRQOL and time to recover from a dialysis session will be used as other outcomes. The study will also capture safety data, based on intradialytic events, hospitalization and mortality. Biochemical (according to the local requirements) and drug prescription data will be monitored for pharma-economic analysis. Serum samples will be collected for future analysis of additional biomarkers.

In summary, patients will go through a 4 week run in period on high flux HD. After this, patients will be randomized to the intervention of high volume online HDF for 6 months, or will continue on high flux HD; both groups will be observed for a 12 month follow up period. Patients will be evaluated for physical activity, HRQOL, laboratories and other measures at the baseline, 3 month, and 6 month time points. Evaluation will be repeated in 3 and 6-months. HRQOL, laboratories, and other outcomes will be tracked over the post-interventional follow up period that lasts 12 months after randomization.

Data will be analyzed according to an intention-to-treat principle (i.e., according to assigned instead of received treatment). With an enrollment target of 110 participants in each arm (considering a drop out of 20%) we estimate the 86 patients will complete the follow up in each arm, what will provide the trial a 90% power to detect a 20% effect with respect to the primary outcome (predefined as a 20% increase in average total steps at the dialysis day in the HDF group compared to the HD group). Because of the nature of the intervention, it will not possible to blind the patients, the local study nurses, or the investigators for the treatment assignment.

Fourteen dialysis centers will be invited to participate. Each participating center will receive two 5008S machines and Cordiax dialyzers to be used in the study of 10 patients in each center. Additional patients can be randomized per center with approval of the steering committee. Centralized randomization will based on a 1:1 protocol, stratified by participating center.

Eligibility criteria: Inclusion Criteria:

* Patients treated three times per week with HD for at least 3 months and up to 24 months;
* Clinically stable according to the evaluation of the investigator;
* Kt/V of \> 1.2;
* Patients with an arteriovenous fistula/graft and permanent catheters with adequate flow.

Exclusion Criteria:

* Age below 18 years;
* Life expectancy less than 3 months because of nonrenal disease;
* Participation in another clinical intervention trial;
* Severe non-compliance regarding frequency and duration of dialysis treatment;
* Patients with severe limitation to mobility (amputated, neurologic and muscular disorders) will be excluded from the study.

Primary outcomes:
measure: The difference in the change in step counts per 24 hours on dialysis days from baseline to the 6-month follow up in patients treated with high volume online HDF versus high-flux HD
timeFrame: Baseline, 3 months and 6 months
measure: The difference in the change in minutes of moderate-to-vigorous physical activity (MVPA) per 24 hours on dialysis days from baseline to the 6-month follow up in patients treated with high volume online HDF versus high-flux HD
timeFrame: Baseline, 3 months and 6 months
Secondary outcomes:
measure: The difference in the change in self-reported dialysis recovery time from baseline to the 6-month follow up in patients treated with high volume online HDF versus high-flux HD
timeFrame: Baseline, 3 months and 6 months
measure: The difference in the change in SF-36 scores from baseline to the 6-month follow up in patients treated with high volume online HDF versus high-flux HD
timeFrame: Baseline, 3 months and 6 months
measure: Pharmacoeconomy (drug use, hospitalization)
timeFrame: Baseline, 3 months and 6 months
measure: Intradialytic events
timeFrame: Baseline, 3 months and 6 months
measure: Mortality
timeFrame: Baseline, 3 months and 6 months
Other outcomes:
Locations:
city: Belo Horizonte
country: Brazil
facility: Instituto Médico Nefrológico
state: Minas Gerais
city: Contagem
country: Brazil
facility: Nefron Contagem
state: Minas Gerais
city: Curitiba
country: Brazil
facility: Irmandade da Santa Casa de Misericórdia de Curitiba
state: Paraná
city: Porto Alegre
country: Brazil
facility: Hospital de Clínicas de Porto Alegre
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Hospital São Lucas PUCRS
state: Rio Grande Do Sul
city: Joinville
country: Brazil
facility: Fundação Pro Rim
state: Santa Catarina
city: Taubaté
country: Brazil
facility: Instituto de Nefrologia de Taubaté
state: São Paulo
city: Rio de Janeiro
country: Brazil
facility: Clínica de Diálise Ingá
city: Rio de Janeiro
country: Brazil
facility: Clínica de Doenças Renais - São Lourenço
city: Rio de Janeiro
country: Brazil
facility: Clínica de Doenças Renais - Un. Botafogo
city: São Paulo
country: Brazil
facility: CETENE
city: São Paulo
country: Brazil
facility: Hospital Alemão Oswaldo Cruz
city: São Paulo
country: Brazil
facility: Hospital do Rim e Universidade Federal de São Paulo
Study officials:
affiliation: PUC-PR
name: Roberto Flávio Pecoits-Filho, PI
role: STUDY_CHAIR
References:
citation: Lima JD, Guedes M, Rodrigues SD, Florido ACS, Moreno-Amaral AN, Barra AB, Canziani ME, Cuvello-Neto A, Poli-de-Figueiredo CE, Pecoits-Filho R, Nakao LS. High-volume hemodiafiltration decreases the pre-dialysis concentrations of indoxyl sulfate and p-cresyl sulfate compared to hemodialysis: a post-hoc analysis from the HDFit randomized controlled trial. J Nephrol. 2022 Jun;35(5):1449-1456. doi: 10.1007/s40620-022-01283-3. Epub 2022 Mar 3.
citation: Guedes M, Dambiski AC, Canhada S, Barra ABL, Poli-de-Figueiredo CE, Cuvello Neto AL, Canziani MEF, Strogoff-de-Matos JP, Raimann JG, Larkin J, Canaud B, Pecoits-Filho R; HDFIT Study Investigators. Achieving high convective volume in hemodiafiltration: Lessons learned after successful implementation in the HDFit trial. Hemodial Int. 2021 Jan;25(1):50-59. doi: 10.1111/hdi.12891. Epub 2020 Oct 15.
citation: Larkin JW, Han M, Han H, Guedes MH, Goncalves PB, Poli-de-Figueiredo CE, Cuvello-Neto AL, Barra ABL, de Moraes TP, Usvyat LA, Kotanko P, Canziani MEF, Raimann JG, Pecoits-Filho R; HDFIT Study Investigators. Impact of hemodialysis and post-dialysis period on granular activity levels. BMC Nephrol. 2020 May 25;21(1):197. doi: 10.1186/s12882-020-01853-2.
citation: Pecoits-Filho R, Larkin JW, Poli-de-Figueiredo CE, Cuvello Neto AL, Barra AB, Canhada S, de Campos LG, Woehl J, Goncalves PB, Han H, de Moraes TP, Raimann JG, Canziani MEF; HDFIT Study Investigators. Design and methodology of the impact of HemoDiaFIlTration on physical activity and self-reported outcomes: a randomized controlled trial (HDFIT trial) in Brazil. BMC Nephrol. 2019 Mar 20;20(1):98. doi: 10.1186/s12882-019-1247-8.