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

Haemodynamic Stability Clinical Trial

Official title:

Uremic Toxin Removal and Hemodynamics in Long-hour Hemodialysis and Hemodiafiltration; a Randomized Cross-over Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01328119
• Other study ID #: NL34908.068.10
• Status: Completed
• Phase: N/A
• First received: March 16, 2011
• Last updated: June 12, 2013
• Start date: October 2011
• Est. completion date: June 2013

Study information

• Verified date: June 2013
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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)

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Haemodynamic Stability
• Uremic Toxins

Intervention

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.

Locations

Country	Name	City	State
Netherlands	Maastricht University Medical Center	Maastricht	Limburg

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

References & 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	haemodynamic response	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.	every 30 minutes until end of dialysis	No