Uremia
Conditions
Keywords
blood pressure, cardiovascular instability, symptomatic hypotension, online hemofiltration, online hemodiafiltration
Brief summary
Convective therapies have been proposed for improving chronic dialysis patient outcomes, including intradialytic symptomatic hypotension. To evaluate the frequency of sessions with intradialytic symptomatic hypotension in different types and doses of convective therapies compared with low-flux hemodialysis (HD), the investigators performed a multicentre, open-label, randomized controlled trial.
Interventions
PROCEDUREonline pre-dilution hemofiltration
Online pre-dilution hemofiltration was performed with a synthetic high-flux membrane and an infusate/blood flow ratio of one
Online pre-dilution hemodiafiltration was performed with a synthetic high-flux membrane with an infusate/blood flow ratio of 0.6 and a dialysate plus infusate rate of 700 ml/min.
Sponsors
A. Manzoni Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Dialysis patients aged 18-80 years * thrice-weekly HD or HDF for at least 6 months * body weight less or equal to 90 Kg * stable clinical condition * written consent
Exclusion criteria
* infections * malignancies * active systemic diseases * active hepatitis or cirrhosis * unstable diabetes * diuresis higher than 200 ml/24h * dysfunction of vascular access * blood flow rate less than 300 ml/min
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intradialytic symptomatic hypotension | all dialysis sessions, three per week, for 2 years | Intradialytic symptomatic hypotension was defined as a rapid symptomatic fall of the systolic blood pressure by at least 30 mmHg or that required nursing and/or medical intervention |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Resistance to erythropoiesis-stimulating agents | Monthly for 2 years | Resistance to erythropoiesis-stimulating agents was measured as (EPO therapy in IU/week)/(Hb in g/dL\*body wheight in kg) |
| Calcium-phosphate metabolism | Monthly for 2 years | Outcome measures: phosphatemia, calcemia and PTH |
| Beta2 microglobulin | Every six months for 2 years | — |
Countries
Italy
Outcome results
None listed