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Completed

NCT Number: NCT01328119

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

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.

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Key information

Conditions

Uremic Toxins Haemodynamic Stability

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Maastricht University Medical Center

Maastricht, Limburg, 5800, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Primary outcomes

  1. 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)

    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 outcomes

  1. haemodynamic response

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Apr 4, 2011
Registry last updated
Jun 13, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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