Non-invasive Assessment to Predict Tolerance to Fluid Removal on Intermittent Kidney Replacement … (NCT05270759) | Clinical Trial Compass
CompletedNot Applicable
Non-invasive Assessment to Predict Tolerance to Fluid Removal on Intermittent Kidney Replacement Therapy
Canada93 participantsStarted 2022-03-01
Plain-language summary
This prospective cohort study aim to investigate the ability of multiple types of assessments including 1) the modified Venous Excess Ultrasound (VExUS) assessment, 2) non-invasive estimation of absolute blood volume (ABV), and 3) change in carotid Doppler at the start of IKRT to predict IDHE in acutely ill hospitalized patients. The secondary aim will be to determine whether each modality improves the prediction of IHDE compared to the evaluation of the attending physician and whether they also predict cerebral hypoxia during IKRT measured by near-infrared spectroscopy (NIRS). Finally, detailed hemodynamic data including relative blood volume monitoring, tissue oximetry, and other parameters will be collected continuously during IKRT sessions enabling exploratory analyses aimed at identifying hemodynamic phenotypes related to IDHE during IKRT.
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
. Adult patient ≥18 year-old
. Hospitalized at the CHUM in the intensive care unit (ICU) or general ward
. Receiving or planned ≥3x/week IKRT treatments
. Planned on-line hemodiafiltration (HDF) or hemodialysis (HD) sessions with ≥1L of fluid removal per session
Exclusion criteria
. Planned hospital discharge, death, or transition to comfort care within 48 hours according to the attending physician
. End of active care (awaiting hospital discharge)
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.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
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 hypotensive event in the peri-dialytic or post-dialytic period
Timeframe: From the initiation of dialysis to 15 minutes after dialysis
Trial details
NCT IDNCT05270759
SponsorCentre hospitalier de l'Université de Montréal (CHUM)