The primary hypothesis of the study is that the use of icodextrin leads to a reduction in extracellular volume compared to glucose 2.27%, but that the effects of icodextrin and glucose 2.27% on plasma will not differ.
ID
Source
Brief title
Condition
- Renal disorders (excl nephropathies)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
In this study the effects of glucose 2.27% and icodextrin 7.5% will be compared
for the long dwell on plasma volume, extracellular volume and blood pressure
control.
Secondary outcome
xx
Background summary
Peritoneal dialysis (PD) patients are mostly overhydrated. Overhydration could
induce hypertension and increase the cardiac workload. In PD, ultrafiltration
of bodywater occurs by dialysis fluids containing different concentrations of
glucose. More ultrafiltration could be realised by using icodextrin, a dialysis
fluid which contains polymers of glucose. Although use of icodextrin or glucose
fluids is not different for blood pressure as expected, because of the better
ultrafiltration capacity of icodextrin. In this study we will compare the
effect of icodextrin in peritoneal dialysis with glucose-containing dialysis
fluids. Especially regulation of the blood pressure and the distribution of
the body water will be studied.
Study objective
The primary hypothesis of the study is that the use of icodextrin leads to a
reduction in extracellular volume compared to glucose 2.27%, but that the
effects of icodextrin and glucose 2.27% on plasma will not differ.
Study design
Patients will be studied according to a randomized cross-over design. The total
duration of the study is 3 months. During a period of one month all patients
are prescribed 2.27% glucose solutions for the long dwell. After the run-in
period patients will receive one-monthly treatment with icodextrin for the log
dwell followed by one-monthly treatment with glucose 2.27% for the long dwell
(A-B), or will start with glucose 2.27% and followed by icodextrin (B-A).
Intervention
Blood sampling
24-hours blood pressure monitoring
I-125 albumine method for assessment of plasma volume
Bromide dilution method for assessment of the extracellular volume
Multifrequency bioimpedance analysis for assessment of the total body water
Assessment of peritoneal ultrafiltration volume and sodium removal by 24-hours
dialysate collection
Assessment of residual renal function by 24-hours urine collection
Study burden and risks
There are no other risks for the patients than known in peritoneal dialysis.
Postbus 5800
6202 AZ Maastricht
NL
Postbus 5800
6202 AZ Maastricht
NL
Listed location countries
Age
Inclusion criteria
clinical stable patients treated with peritoneal dialysis
Exclusion criteria
chronic heart failure NYHA III or higher
known hypersensitivity to icodextrin
pacemaker
pregnancy
younger than 18 years
inability to give informed consent
within one month of peritonitis
patients unable to stop icodextrin on clinical grounds
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 |
---|---|
EudraCT | EUCTR2006-006211-80-NL |
CCMO | NL15242.068.07 |