Dialysis Membranes and Hemodynamic Tolerance Clinical Trial
Official title:
Assessment of Subjective and Hemodynamic Tolerance of Different High- and Low-flux Dialysis Membranes in Patients Undergoing Chronic Intermittent Hemodialysis: a Randomized Controlled Trial
| Verified date | July 2013 |
| Source | Ospedale Regionale di Locarno |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Switzerland: Swissmedic |
| Study type | Interventional |
Background:
High- and low-flux dialysis membranes made of different materials may correlate with various
hemodynamic tolerance profiles. This study aims to investigate hemodynamic response and
incidence of hypotensive episodes by comparing some of the most commonly used high- and
low-flux dialyzers.
Methodology:
The study was designed as an open label, randomized, cross-over investigation, including 25
patients undergoing chronic hemodialysis. Four polysulfone dialyzers of 1.8 m2, A
(Revaclear, Gambro), B (Helixone high flux, Fresenius), C (Xevonta, BBraun) and D (Helixone
low flux, Fresenius), were compared with each other. The hemodynamic profile was assessed
with a non-invasive technique and patients were asked to provide tolerance feedback through
a questionnaire.
| Status | Completed |
| Enrollment | 25 |
| Est. completion date | January 2013 |
| Est. primary completion date | January 2013 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 95 Years |
| Eligibility |
Inclusion Criteria: - age 18 and older - ability to understand the information presented and sign the informed consent - chronic hemodialysis for at least 8 weeks - stable dialysis prescriptions and modality in the 2 weeks prior to protocol implementation Exclusion Criteria: - mental illness; - inability to understand the information presented and sign the informed consent; - acute disease requiring hospitalization at the time of patient enrolment - pregnancy and breast feeding |
Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Switzerland | Ospedale Regionale di Locarno | Locarno | Ticino |
| Lead Sponsor | Collaborator |
|---|---|
| Ospedale Regionale di Locarno |
Switzerland,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | comparative evaluation of mean hemodynamic parameters (i.e. systolic and diastolic blood pressure, peripheral resistance and cardiac output) during dialysis | 4 weeks | No | |
| Primary | comparative evaluation of subjective tolerance across the various membranes | As to the assessment of subjective tolerance, we decided to administer the questionnaire designed by Cruz et al. [Cruz DN, Mahnensmith RL, Brickel HM, Perazella MA. Midodrine and cool dialysate are effective therapies for symptomatic intradialytic hypotension. Am. J. Kidney Dis. 1999 Mag;33(5):920-926] then modified by Teruel et al. [Teruel JL, Martins J, Merino JL, Fernández Lucas M, Rivera M, Marcén R, et al. Temperature of the dialysis bath and hemodialysis tolerance. Nefrología: PublicaciónOficial De La Sociedad Española Nefrologia. 2006;26(4):461-468] and to integrate it with a 1 to 10 numerical scale to assess patient well-being | 4 weeks | No |
| Primary | comparative evaluation of Kt/V and of beta-2 microglobulin removal | 4 weeks | No | |
| Secondary | comparative analysis of the incidence of symptomatic and non-symptomatic systolic pressure drops (> 20 mmHg) | 4 weeks | No |