Efficacy of PRUcalopride in Critically Ill Patients With Paralytic ILeus (NCT04190173) | Clinical Trial Compass
UnknownPhase 3
Efficacy of PRUcalopride in Critically Ill Patients With Paralytic ILeus
Thailand62 participantsStarted 2017-07-01
Plain-language summary
Paralytic ileus is a common intestinal dysfunction in critically ill patients. There are still no established the effective medications except correcting the primary causes and prokinetics trial which limited in efficacy and potential adverse events.
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:
* Medical patients with APACHE II score \>= 15
* Paralytic ileus: small bowel diameter \>= 4 cm or large bowel diameter \>= 6 cm
Exclusion:
* no current prokinetic use
* Severe peritonitis or bowel inflammation
* ESRD needed hemodialysis
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
Change of maximum bowel diameter from baseline at 24 hours
Timeframe: after first dose intervention to next 24 hours
2
Change of maximum bowel diameter from baseline at 48 hours
Timeframe: after first dose intervention to next 48 hours
3
Change of maximum bowel diameter from baseline at 72 hours
Timeframe: after first dose intervention to next 72 hours
4
Change of maximum bowel diameter from baseline at 96 hours
Timeframe: after first dose intervention to next 96 hours
5
Change of maximum bowel diameter from baseline at 120 hours
Timeframe: after first dose intervention to next 120 hours