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

Not Applicable

Completed

• Conditions: Uremic Toxins; Haemodynamic Stability
• Interventions: Other: 4-hour HD, 4-hour HDF, 8-hour HD and 8-hour HDF

• Registration Number: NCT01328119
• Lead Sponsor: Maastricht University Medical Center

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 available

Study Timeline

• Study First Submitted: 2011-03-16
• Study First Submitted QC: 2011-03-31
• Study First Posted: 2011-04-04
• Study Start: 2011-10
• Primary Completion: 2013-01
• Status Verified: 2013-06
• Study Completion: 2013-06
• Last Update Submitted: 2013-06-12
• Last Update Posted: 2013-06-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
hemodialysis patients	4-hour HD, 4-hour HDF, 8-hour HD and 8-hour HDF	conventional hemodialysis patients

Primary Outcome Measures

Name	Time	Method
removal of uremic toxins	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)	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.

Secondary Outcome Measures

Name	Time	Method
haemodynamic response	every 30 minutes until end of dialysis	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.

Trial Locations

Locations (1)

Maastricht University Medical Center; 🇳🇱 Maastricht, Limburg, Netherlands