Uremic Toxin Removal and Hemodynamics in Long-hour Hemodialysis and Hemodiafiltration

NCT ID: NCT01328119

Last Updated: 2013-06-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-10-31
• Study Completion Date: 2013-06-30

Brief Summary

Rationale: The mortality of end-stage renal disease (ESRD) patients on dialysis remains high. This may at least be partly due to the insufficient removal of (especially protein-bound) uremic toxins which have been associated with cardiovascular morbidity and mortality. It is unknown whether the combination of long-hour haemodialysis (HD) with convection increases the removal of these toxins. Long-hour HD and long-hour haemodiafiltration (HDF) may also improve haemodynamic stability which is an important factor in treatment quality. The investigators aim to study the removal of uremic toxins in long-hour HD and HDF and to compare the haemodynamics between 4-hour and 8-hour HD and HDF.

Objectives: The primary aim is to study the removal of (especially protein-bound) uremic toxins in 4-hour and 8-hour HD and HDF. A secondary aim is to compare the haemodynamic response between 4-hour and 8-hour HD and HDF.

Conditions

Uremic Toxins; Haemodynamic Stability

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

hemodialysis patients

conventional hemodialysis patients

Group Type: OTHER

4-hour HD, 4-hour HDF, 8-hour HD and 8-hour HDF

Intervention Type: OTHER

Prevalent conventional HD (CHD) patients (dialysing 3 days a week during 4 hours per dialysis session) will undergo, in random order, a mid-week 4-hour HD session, a mid-week 4-hour HDF session, a mid-week 8-hour HD session, and a mid-week 8-hour HDF session with a 2-week interval between every session to assess the influence of treatment duration and of convection on the removal of uremic toxins and on the haemodynamic responses and autonomic nervous regulation. In between the study dialysis sessions these patients will receive routine CHD treatments.

Interventions

4-hour HD, 4-hour HDF, 8-hour HD and 8-hour HDF

Prevalent conventional HD (CHD) patients (dialysing 3 days a week during 4 hours per dialysis session) will undergo, in random order, a mid-week 4-hour HD session, a mid-week 4-hour HDF session, a mid-week 8-hour HD session, and a mid-week 8-hour HDF session with a 2-week interval between every session to assess the influence of treatment duration and of convection on the removal of uremic toxins and on the haemodynamic responses and autonomic nervous regulation. In between the study dialysis sessions these patients will receive routine CHD treatments.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• prevalent conventional HD patients
• AV-fistula enabling double-needle vascular access with blood flow rate of at least 350 ml/min
• informed consent
• age more than 18 years

Exclusion Criteria

• withdrawal of consent
• acute intercurrent illness (infection, malignancy, cardiovascular event, uncontrolled diabetes)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Maastricht University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Maastricht University Medical Center

Maastricht, Limburg, Netherlands

Countries

Netherlands

References

Perl J, Chan CT. Home hemodialysis, daily hemodialysis, and nocturnal hemodialysis: Core Curriculum 2009. Am J Kidney Dis. 2009 Dec;54(6):1171-84. doi: 10.1053/j.ajkd.2009.06.038. Epub 2009 Sep 12. No abstract available.

Reference Type: BACKGROUND

PMID: 19748715 (View on PubMed)

Other Identifiers

NL34908.068.10

Identifier Type: -

Identifier Source: org_study_id