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

NCT01328119 | Completed

• 1 other identifier: NL34908.068.10
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• removal of uremic toxins

  To measure uremic toxin and electrolyte removal, reduction ratios, dialytic clearances and mass removal in collected dialysate will be determined. Blood samples will be taken from the inlet blood lines immediately before the onset of dialysis and at 15, 30, 60, 120, 240 minutes (4-hour and 8-hour sessions) and at 360 and 480 minutes (8-hour sessions). Furthermore, ultrafiltrate and dialysate will be continuously collected in a fractionated way.

  before dialysis and at 15,30,60,120,240 minutes (4-hour and 8-hour sessions) and at 360 and 480 minutes (8-hour sessions)

Secondary Outcomes (1)

• haemodynamic response

  every 30 minutes until end of dialysis

Study Arms (1)

hemodialysis patients

OTHER

conventional hemodialysis patients

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

Interventions

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

hemodialysis patients

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Maastricht University Medical Center: lead

Study Sites (1)

Maastricht University Medical Center

Maastricht, Limburg, 5800, Netherlands

Location

Related Publications (1)

• 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.

  PMID: 19748715 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2011
• First Posted: April 4, 2011
• Study Start: October 1, 2011
• Primary Completion: January 1, 2013
• Study Completion: June 1, 2013
• Last Updated: June 13, 2013

Record last verified: 2013-06

Locations

NL (1)