Effect of Naloxegol on Postoperative Ileus in Patients Undergoing Cardiac Surgery (NCT04433390) | Clinical Trial Compass
CompletedPhase 3
Effect of Naloxegol on Postoperative Ileus in Patients Undergoing Cardiac Surgery
France305 participantsStarted 2020-10-14
Plain-language summary
Postoperative ileus, defined as the transient postoperative functional inhibition of propulsive bowel activity, commonly occurs in patients after cardiac surgery and contributes to postoperative morbidity.
Naloxegol is a peripheral opioid receptor antagonist. Recent studies showed that naloxegol is effective in the treatment of chronic opioid-induced constipation but there is no data on its use in the management of postoperative ileus after cardiac surgery.
The main objective of this prospective, double-blind, randomized, placebo-controlled trial is to assess the effectiveness of the perioperative use of naloxegol in reducing the duration of the postoperative ileus in patients undergoing cardiac surgery.
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:
* \> 18 years old,
* Undergoing cardiac surgery with cardiopulmonary bypass,
* For women of child bearing potential without contraception, beta-HCG negative result
* Having signed a written informed consent form,
* Affiliation to the social security system.
Exclusion Criteria:
* Allergy or known hypersensitivity to Naloxegol or any of the excipients or any other opioid antagonist
* Pregnant or breastfeeding women
* Severe hepatic failure, history of cirrhosis
* Moderate or severe renal failure (GFR\<60ml/min)
* Concomitant treatment with a strong cytochrome P450 3A4 inhibitor
* History of acute gastro-intestinal obstruction known or suspected
* History of digestive arteritis
* Clinically relevant alteration of the blood-brain-barrier
* Cancer with increased risk of gastro-duodenal perforation
* Disorder that could alter the integrity of the gastrointestinal lining
* Regular treatment with laxative drugs
* Concomitant treatment with methadone
* Patient unable to take a drug by oral route
* Patient under protection of the adults (guardianship, curators or safeguard of justice),
* Patient included or planning to be included in another research protocol relating to medications.
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
Evaluate the effect of perioperative naloxegol administration on the duration of postoperative ileus after cardiac surgery