Status:
COMPLETED
Effect of Naloxegol on Postoperative Ileus in Patients Undergoing Cardiac Surgery
Lead Sponsor:
CMC Ambroise Paré
Conditions:
Postoperative Ileus (Post Cardiac Surgery Constipation)
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 morbi...
Detailed Description
Digestive complications following cardiac surgery, such as paralytic ileus and Ogilvie syndrome, are frequent and worsen the prognosis of patients. They pose a real problem of care in intensive care, ...
Eligibility Criteria
Inclusion
- \> 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
- 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.
Key Trial Info
Start Date :
October 14 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 3 2022
Estimated Enrollment :
305 Patients enrolled
Trial Details
Trial ID
NCT04433390
Start Date
October 14 2020
End Date
March 3 2022
Last Update
March 8 2022
Active Locations (1)
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1
CMC Ambroise Paré
Neuilly-sur-Seine, Neuilly Sur Seine, France, 92200