Effects of Convective Therapies in Dialysis Patients (NCT01583309) | Clinical Trial Compass
CompletedPhase 3
Effects of Convective Therapies in Dialysis Patients
Italy146 participantsStarted 2003-11
Plain-language 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.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial tested convective therapies — like hemodiafiltration — compared to standard hemodialysis in uremia patients, specifically looking at episodes of low blood pressure during treatment; is convective therapy something worth considering for me if I struggle with blood pressure drops during my dialysis sessions?
2Since this was a Phase 3 trial that has already been completed, has the data been published, and does it show any meaningful difference in how often patients experienced symptomatic hypotension with convective therapy versus conventional dialysis?
3If the results from this trial support convective therapy as being safer or better tolerated during sessions, is that type of treatment actually available at the dialysis center where I receive care?
4Could switching to a convective therapy approach affect anything else about my treatment — like session length, frequency, or how I feel afterward — beyond just the blood pressure issue the trial was measuring?
5Given that this trial is now complete, are there other ongoing or newer studies on dialysis tolerance that might be even more relevant to my specific situation, or is the evidence from this trial strong enough to guide a change in my treatment?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Intradialytic symptomatic hypotension
Timeframe: all dialysis sessions, three per week, for 2 years