To analyze how potassium handling, volume and sodium status change in stable anuric chronic hemodialysis patients (CKD-5D) in response to higher dialysate potassium.
ID
Source
Brief title
Condition
- Nephropathies
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome will be RBC potassium (mmol/L)
Secondary outcome
Secondary endpoints will include serum potassium, potassium removal, serum
sodium, sodium removal, total ultrafiltration volume, total body water, and
systolic blood pressure as well as changes in serum bicarbonate, insulin, and
plasma aldosterone.
Background summary
In hemodialysis patients hyperkalemia is often attributed to dietary potassium
intake. Currently, hemodialysis patients are advised to adhere to a potassium
restricted diet. Some differentiations, however, are to be made. That is,
hyperkalemia may also be caused by changes in the internal potassium balance. A
cohort study showed that urea levels, metabolic acidosis, and hyperglycemia but
not anuria or hyperkalemic drugs were associated with pre-dialysis serum
potassium concentrations.[1] Moreover, as in non-dialysis CKD, TBK has been
shown to be decreased in dialysis patients. Importantly, one study by Adrogué*s
group indicated that lower TBK in hemodialysis patients has prognostic impact.
The median survival was 55 months in TBK-depleted subjects vs. 100 months in
subjects with normal TBK. The same group showed that lowering of serum
potassium by the dialysate resulted in higher blood pressure one hour
post-dialysis. Moreover, serial measurements of total body minerals showed that
a TBK increment was associated with lower total body sodium, although other
studies could not reproduce this observation. In summary, a higher potassium
dialysate concentration (4 mmol/l) may restore TBK. Whether this would also
lead to improved blood pressure regulation, sodium removal, and volume control
is unknown.
Study objective
To analyze how potassium handling, volume and sodium status change in stable
anuric chronic hemodialysis patients (CKD-5D) in response to higher dialysate
potassium.
Study design
Single-blind, interventional cross-over study
Intervention
Hemodialysis patients will be treated for 4 weeks using widely used dialysate
solutions as part of standard care containing potassium either 2 mmol/L or 4
mmol/L in random order.
Study burden and risks
Participating in this research project will not lead to personal benefit.
However, higher dialysate potassium might lead to better (intradialytic) blood
pressure and volume control. Because of study-related non-invasive and invasive
measurements, including skin biopsies, additional burden is expected when
participating in this study. The subjects undergo hemodialysis 3 x 4 hrs/week.
There will be one screening visit and two study visits, which will take place
during regular hemodialysis treatment. The study visits, including
hemodialysis, will take 2 hours extra in total. Study procedures include:
venous blood drawings, skin biopsies, measurements of volume status (using
weight and bioimpedance measurements), ECG recordings and central and
peripheral hemodynamics (by using continuous finger arterial pressure [FinAp]
waveform registration, Nexfin®. Futhermore, we will analyse the
microcirculation under the tongue using a sidestream dark field (SDF) camera. A
higher dialysate potassium concentration may incur development of hyperkalemia.
For that reason, pre-dialysis serum potassium will be measured weekly. In case
serum potassium exceeds >=6 mmol/L or becomes lower thand 3.0 mmol/L patients
will leave the study.
Meibergdreef 9
Amsterdam-Zuidoost 1105 AZ
NL
Meibergdreef 9
Amsterdam-Zuidoost 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
• Adult (age >= 18 years) stable anuric hemodialysis patients that undergo
treatment 3 x 4 hrs/week.
• Written informed consent
Exclusion criteria
• Pre-dialysis serum potassium <4.0 mmol/L or > 6.0 mmol/L or use of potassium
binders
• Patients with previous history of ventricular cardiac arrhythmia.
• Uncontrolled hypertension (systolic BP >180 mmHg on at least 3 of the last 5
dialysis treatments) or intradialytic hypotension on >3 dialysis treatments in
the last month
• Patients with insulin dependent diabetes mellitus
• Patients with a life expectancy < 6 months.
• Expected kidney transplantation < 2 months.
• Cognitively impaired or incapacitated subjects.
• Women who are pregnant, breastfeeding or consider pregnancy in the coming 6
months.
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 | NL66478.018.18 |