Low-intensity Versus Medium-intensity Continuous Kidney Replacement Therapy for Critically Ill Pa… (NCT06014801) | Clinical Trial Compass
RecruitingPhase 2/3
Low-intensity Versus Medium-intensity Continuous Kidney Replacement Therapy for Critically Ill Patients
Japan400 participantsStarted 2023-10-30
Plain-language summary
This clinical trial aims to investigate whether the low treatment intensity (12 mL/kg/hr, low-dose hemodialysis/filtration) or the medium treatment intensity (25 mL/kg/hr, standard-dose hemodialysis/filtration) is more effective and safer for continuous renal replacement therapy in critically ill patients.
Who can participate
Age range
18 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
. Adults (18 years of age or older, regardless of the time since ICU admission) currently admitted to an intensive care unit\*.
. A diagnosis of acute kidney injury is made according to the Kidney Disease: Improving Global Outcomes (KDIGO) international diagnostic criteria (one of the following is met)
. The treating intensivist believes that continuous kidney replacement therapy is necessary
Exclusion criteria
. Receiving chronic dialysis or scheduled for initiation of chronic dialysis
. Undergoing any kidney replacement therapy or blood purification therapy within 48 hours
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 is comparing two different intensities of continuous kidney replacement therapy — low versus medium — so what does that actually mean for how much time I'd spend connected to the machine each day, and how would that fit with my current condition in the ICU?
2The main thing this trial is measuring is a combination of death and how long I'd need kidney replacement therapy over 28 days — given where I am right now, what does my doctor think my realistic outlook looks like on either of those two measures?
3Since this is a Phase 2/3 trial, there's still some uncertainty about whether one intensity is clearly safer or more effective than the other — are there already any preliminary findings or safety signals my doctor is aware of that might point toward one approach being better for someone in my situation?
4Would I be randomly assigned to low- or medium-intensity treatment without my care team being able to choose based on my specific needs, and is there any risk that the assigned intensity might not be the best match for how severe my kidney injury is?
5Before considering this trial, should I ask whether the standard of care my hospital already uses — either low or medium intensity — might be just as good an option for me, without the uncertainties that come with being part of a research study?
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
Composite of death and duration of kidney replacement therapy at 28 days
Timeframe: 28 days or hospital discharge whichever comes first
. When kidney replacement therapy using other dialysate or replacement fluids, such as citrate dialysis, is preferred due to coexisting bleeding disorders or allergy to acetate
. Concomitant blood purification therapy other than hemofiltration/dialysis, such as plasma exchange
. The patient is in a very critical condition and the treating physician believes that survival for more than 24 hours is unlikely
. Previous participation in the study
. After receiving a full explanation of the study and with full understanding, a patient do not consent to participate in the study of their own (or their substitute decision maker's) will.
. The principal investigator (or an investigator) thinks it to be inappropriate to participate in this study.