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

History of Changes

Tracking Information
First Received Date ^ICMJE	March 16, 2011
Last Updated Date	June 12, 2013
Start Date ^ICMJE	October 2011
Primary Completion Date	January 2013 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: March 31, 2011)	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.
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01328119 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: March 31, 2011)	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.
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Uremic Toxin Removal and Hemodynamics in Long-hour Hemodialysis and Hemodiafiltration
Official Title ^ICMJE	Uremic Toxin Removal and Hemodynamics in Long-hour Hemodialysis and Hemodiafiltration; a Randomized Cross-over Study
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Uremic Toxins Haemodynamic Stability
Intervention ^ICMJE	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.
Study Arm (s)	hemodialysis patients conventional hemodialysis patients Intervention: Other: 4-hour HD, 4-hour HDF, 8-hour HD and 8-hour HDF
Publications *	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.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	20
Completion Date	June 2013
Primary Completion Date	January 2013 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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)
Gender	Both
Ages	18 Years to 80 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Netherlands

Administrative Information
NCT Number ^ICMJE	NCT01328119
Other Study ID Numbers ^ICMJE	NL34908.068.10
Has Data Monitoring Committee	Not Provided
Responsible Party	Maastricht University Medical Center
Study Sponsor ^ICMJE	Maastricht University Medical Center
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Maastricht University Medical Center
Verification Date	June 2013
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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