Primary research question: Is there a difference in plasma- and dialysate clearances of middle molecules and larger molecules, with different electrical charges, between treatment with standard haemodialysis, high-flux haemodialysis and on-line…
ID
Source
Brief title
Condition
- Renal disorders (excl nephropathies)
- Renal and urinary tract therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Dialysate samples: Samples collected: continuously and separated in aliquots
every hour.
Phosphate, Cystatine C, Beta 2 Microglobuline, Vitamin B12, Urea, Creatinin.
Blood samples:
Before start treatment: Haemoglobin, Haematocrit, Albumin, CRP.
Before and during treatment: Samples collected: before treatment, every hour
and at treatment end.
Before artificial kidney and just before venous return. (i.e. after post
dilution substitution)
Phosphate, Cystatine C, Beta 2 Microglobuline, Vitamin B12, Urea, Creatinin,
Albumin, Haematocrit.
Once every type of treatment: D-dimeer en TAT as measures of degree of clotting
in the artificial kidney. Before and after treatment.
Anti- Xa as measure of activity of Nadoparin. Before and after treatment.
C3D as measure of complement activation. After treatment.
Secondary outcome
- Diascan measurement on the Gambro AK 200-Ultra S.
Background summary
In patients with end-stage renal disease (ESRD) treated with standard low-flux
haemodialysis, many solutes still accumulate. This accumulation probably is
responsible for several long-term complications of chronic haemodialysis.
On-line haemodiafiltration combines diffusive- and convective clearance and is
considered to be superior in clearance of middle- and larger molecules. Several
studies have examined the difference between haemodialysis and on-line
haemodiafiltration regarding long-term morbidity and mortality. None of these
studies has examined in detail the plasma clearance and dialysate clearance of
middle- and large molecules.
In this study we will examine the plasma- and dialysate clearances of
phosphate, several middle molecules (500 - 5000 Dalton) and larger molecules.
Phosphate is a small molecule (96 Dalton) but its clearance appears to be very
different from the clearance of other small molecules.
Study objective
Primary research question:
Is there a difference in plasma- and dialysate clearances of middle molecules
and larger molecules, with different electrical charges, between treatment with
standard haemodialysis, high-flux haemodialysis and on-line haemodiafiltration?
Secondary research question:
Is the dialysis Kt/V measured with Diascan comparable to the single pool
(DaugirdasII) Kt/V and/or the equilibrated Kt/V calculated with BUN
measurements in blood samples before, during and after dialysis
Study design
Study design:
Clinical-, prospective-, randomised-, crossover study.
Intervention
Treatment 1: Low-flux haemodialysis
Qb: 350ml/min
Qd: 700ml/min. Temp: 36°C
Gambro AK 200 Ultra S
Gambro Polyflux 17 L
4 hours
Nadoparin: 1st shot and 2nd shot after 2 hours.
Treatment 2:
High-flux haemodialysis
Qb: 350ml/min
Qd: 700ml/min. Temp: 36°C
Gambro AK 200 Ultra S
Gambro Polyflux 170H
4 hours
Nadoparin: 1st shot and 2nd shot after 2 hours.
Treatment 3:
On-line haemodiafiltration Postdilution.
Qb: 350ml/min
Qd: 700ml/min. Temp: 36°C
Qs: 25% of Qb minus UF
Gambro AK 200 Ultra S
Gambro Polyflux 170H
4 hours
Nadoparin: 1st shot and 2nd shot after 2 hours.
Study burden and risks
Nature and extent of the burden and risks are considered minimal.
Postbus 9101
6500HB Nijmegen
Nederland
Postbus 9101
6500HB Nijmegen
Nederland
Listed location countries
Age
Inclusion criteria
Dialysis patients > 18 years of age.
Dialysis > 3 months.
Signed informed consent.
Uncomplicated hemodialysis.
AV fistula with flow > 350ml/min.
Residual function < 1 ml/min.
Hemoglobin level between 6.8 - 8.3 mmol/l.
No bleeding tendency.
Exclusion criteria
Instable dialysis
No bleeding tendency.
No informed consent.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL18545.091.07 |