Impact of HemoDiaFIltration on Physical Activity and Self- Reported Outcomes

NCT02787161 | Completed DMC

• 1 other identifier: PUCPR02
• Study Type: interventional
• Target: 195
• Locations: 1 country
• Sites: 13

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.

Conditions

Chronic Kidney Disease

Keywords

Chronic Kidney Disease; Hemodialysis; Hemodiafiltration; Renal Replacement Therapy; Physical Activity; Accelerometer

Outcome Measures

Primary Outcomes (2)

• 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

  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.

  Baseline, 3 months and 6 months

• 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

  Baseline, 3 months and 6 months

Secondary Outcomes (5)

• 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

  Baseline, 3 months and 6 months

• 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

  Baseline, 3 months and 6 months

• Pharmacoeconomy (drug use, hospitalization)

  Baseline, 3 months and 6 months

• Intradialytic events

  Baseline, 3 months and 6 months

• Mortality

  Baseline, 3 months and 6 months

Study Arms (2)

Hemodialysis

ACTIVE COMPARATOR

Patients who are treated with high flux hemodialysis will continue the same treatment with high flux hemodialysis.

Device: Hemodialysis

Hemodiafiltration

EXPERIMENTAL

Patients who are treated with high flux hemodialysis will be switched to hemodiafiltration for 6 months.

Device: Hemodiafiltration

Interventions

Hemodiafiltration DEVICE

High volume online HDF

Also known as: High volume online HDF

Hemodiafiltration

Hemodialysis DEVICE

High-flux HD

Also known as: High-flux HD

Hemodialysis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pontifícia Universidade Católica do Paraná: lead
• Fresenius AG: collaborator

Study Sites (13)

Instituto Médico Nefrológico

Belo Horizonte, Minas Gerais, Brazil

Location

Nefron Contagem

Contagem, Minas Gerais, Brazil

Location

Irmandade da Santa Casa de Misericórdia de Curitiba

Curitiba, Paraná, Brazil

Location

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Location

Hospital São Lucas PUCRS

Porto Alegre, Rio Grande do Sul, Brazil

Location

Fundação Pro Rim

Joinville, Santa Catarina, Brazil

Location

Instituto de Nefrologia de Taubaté

Taubaté, São Paulo, Brazil

Location

Clínica de Diálise Ingá

Rio de Janeiro, Brazil

Location

Clínica de Doenças Renais - São Lourenço

Rio de Janeiro, Brazil

Location

Clínica de Doenças Renais - Un. Botafogo

Rio de Janeiro, Brazil

Location

CETENE

São Paulo, Brazil

Location

Hospital Alemão Oswaldo Cruz

São Paulo, Brazil

Location

Hospital do Rim e Universidade Federal de São Paulo

São Paulo, Brazil

Location

Related Publications (4)

• 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.

  PMID: 35239175 DERIVED

• 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.

  PMID: 33058473 DERIVED

• 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.

  PMID: 32450793 DERIVED

• 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.

  PMID: 30894141 DERIVED

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Motor Activity

Interventions

Hemodiafiltration; Renal Dialysis

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Renal Replacement Therapy; Therapeutics; Sorption Detoxification; Hemofiltration; Extracorporeal Circulation; Surgical Procedures, Operative

Study Officials

• Roberto Flávio Pecoits-Filho, PI

  PUC-PR

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, FASN, FACP

Study Record Dates

• First Submitted: April 20, 2016
• First Posted: June 1, 2016
• Study Start: August 1, 2016
• Primary Completion: April 1, 2018
• Study Completion: September 1, 2018
• Last Updated: September 16, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

BR (13)