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Impact of HemoDiaFIltration on Physical Activity and Self- Reported Outcomes (HDFIT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02787161
Recruitment Status : Completed
First Posted : June 1, 2016
Last Update Posted : September 16, 2019
Sponsor:
Collaborator:
Fresenius AG
Information provided by (Responsible Party):
Roberto Pecoits-Filho, Pontifícia Universidade Católica do Paraná

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.

Condition or disease Intervention/treatment Phase
Chronic Kidney Disease Device: Hemodiafiltration Device: Hemodialysis Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 195 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Impact of HemoDiaFIltration on Physical Activity and Self-reported Outcomes: a Randomized Controlled Trial (HD-FIT Trial)
Actual Study Start Date : August 2016
Actual Primary Completion Date : April 2018
Actual Study Completion Date : September 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Hemodialysis
Patients who are treated with high flux hemodialysis will continue the same treatment with high flux hemodialysis.
Device: Hemodialysis
High-flux HD
Other Name: High-flux HD

Experimental: Hemodiafiltration
Patients who are treated with high flux hemodialysis will be switched to hemodiafiltration for 6 months.
Device: Hemodiafiltration
High volume online HDF
Other Name: High volume online HDF




Primary Outcome Measures :
  1. 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 [ Time Frame: Baseline, 3 months and 6 months ]
    To capture activity in the study, we will use the Actigraph ™ device to measure acceleration and count steps during 7 days at baseline, 3 and 6 months evaluations, according to a previously described protocol for dialysis patients. A 4s step filter is an intrinsic property of the Actigraph ™ that screens out erroneous steps that might result as from shuffling, standing up, sitting up, sitting down, and vibrations from a moving vehicle. The Actigraph ™ is lightweight (19g), clips at the waist, and provides feedback with on-instrument digital display of step counts. It interfaces with the internet via bluetooth, allowing upload of date and time stamped step counts.

  2. 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 [ Time Frame: Baseline, 3 months and 6 months ]

Secondary Outcome Measures :
  1. 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 [ Time Frame: Baseline, 3 months and 6 months ]
    Dialysis recovery time will be assessed at baseline and at 3 and 6 months of follow-up in both arms. The dialysis recovery time survey asks the question, " How long does it take to recover from a dialysis session?" . This test has been validated in HD studies, and it is interpreted easily, is easy to respond to, shows stability over time by test-retest, shows both convergent and divergent validity, and is sensitive to change.

  2. 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 [ Time Frame: Baseline, 3 months and 6 months ]
    HRQOL will be assessed at baseline and at 3 and 6 months of follow- up with the Kidney Disease Quality of Life - Short Form (KDQOL-SF), adapted and validated to Brazilian Portuguese. This questionnaire covers different domains to face the multidimensional nature of HRQOL. The eight domains of the SF-36 can be summarized in two summary scores, one for physical functioning (the physical composite score [ PCS]) and one for mental functioning (the mental composite score [MCS]). Questionnaires will be applied at the baseline, and 3 and 6 months in both arms. Analysis will include PCS and MCS.

  3. Pharmacoeconomy (drug use, hospitalization) [ Time Frame: Baseline, 3 months and 6 months ]
    Income, social status, prescription of drugs, hospitalization

  4. Intradialytic events [ Time Frame: Baseline, 3 months and 6 months ]
    Events

  5. Mortality [ Time Frame: Baseline, 3 months and 6 months ]
    Survival



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02787161


Locations
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Brazil
Instituto Médico Nefrológico
Belo Horizonte, Minas Gerais, Brazil
Nefron Contagem
Contagem, Minas Gerais, Brazil
Irmandade da Santa Casa de Misericórdia de Curitiba
Curitiba, Paraná, Brazil
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande Do Sul, Brazil
Hospital São Lucas PUCRS
Porto Alegre, Rio Grande Do Sul, Brazil
Fundação Pro Rim
Joinville, Santa Catarina, Brazil
Instituto de Nefrologia de Taubaté
Taubaté, São Paulo, Brazil
Clínica de Diálise Ingá
Rio de Janeiro, Brazil
Clínica de Doenças Renais - São Lourenço
Rio de Janeiro, Brazil
Clínica de Doenças Renais - Un. Botafogo
Rio de Janeiro, Brazil
CETENE
São Paulo, Brazil
Hospital Alemão Oswaldo Cruz
São Paulo, Brazil
Hospital do Rim e Universidade Federal de São Paulo
São Paulo, Brazil
Sponsors and Collaborators
Pontifícia Universidade Católica do Paraná
Fresenius AG
Investigators
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Study Chair: Roberto Flávio Pecoits-Filho, PI PUC-PR
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Roberto Pecoits-Filho, MD, PhD, FASN, FACP, Pontifícia Universidade Católica do Paraná
ClinicalTrials.gov Identifier: NCT02787161    
Other Study ID Numbers: PUCPR02
First Posted: June 1, 2016    Key Record Dates
Last Update Posted: September 16, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Roberto Pecoits-Filho, Pontifícia Universidade Católica do Paraná:
Chronic Kidney Disease
Hemodialysis
Hemodiafiltration
Renal Replacement Therapy
Physical Activity
Accelerometer
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency