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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT01328119
First received: March 16, 2011
Last updated: June 12, 2013
Last verified: June 2013

March 16, 2011
June 12, 2013
October 2011
January 2013   (final data collection date for primary outcome measure)
removal of uremic toxins [ Time Frame: 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) ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01328119 on ClinicalTrials.gov Archive Site
haemodynamic response [ Time Frame: every 30 minutes until end of dialysis ] [ Designated as safety issue: No ]
BP, heart rate, heart rate variability, cardiac output and systemic vascular resistance will be measured every 30 minutes by the Task Force Monitor. Skin microcirculation will be measured with laser Doppler flowmetry every 120 min until the end of the treatment.
Same as current
Not Provided
Not Provided
 
Uremic Toxin Removal and Hemodynamics in Long-hour Hemodialysis and Hemodiafiltration
Uremic Toxin Removal and Hemodynamics in Long-hour Hemodialysis and Hemodiafiltration; a Randomized Cross-over Study

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Uremic Toxins
  • Haemodynamic Stability
Other: 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.
hemodialysis patients
conventional hemodialysis patients
Intervention: Other: 4-hour HD, 4-hour HDF, 8-hour HD and 8-hour HDF
Perl J, Chan CT. Home hemodialysis, daily hemodialysis, and nocturnal hemodialysis: Core Curriculum 2009. Am J Kidney Dis. 2009 Dec;54(6):1171-84. Epub 2009 Sep 12. Review. No abstract available.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
June 2013
January 2013   (final data collection date for primary outcome measure)

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)
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT01328119
NL34908.068.10
Not Provided
Maastricht University Medical Center
Maastricht University Medical Center
Not Provided
Not Provided
Maastricht University Medical Center
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP