ileus after cardiac surgery MedDRA version: 20.0 Level: LLT Classification code 10017501 Term: Functional disturbances following cardiac surgery System Organ Class: 100000004863 MedDRA version: 20.1 Level: LLT Classification code 10051798 Term: Postoperative constipation System Organ Class: 100000004863 MedDRA version: 20.0 Level: LLT Classification code 10071128 Term: Opioid induced constipation System Organ Class: 100000004856
Conditions
Interventions
Trade Name: MOVENTIG 12.5 mg et 25 mg
Pharmaceutical Form: Tablet
INN or Proposed INN: Naloxegol Oxalate
Other descriptive name: NALOXEGOL
Concentration unit: mCi/mg millicurie(s)/milligram
Concentrat
Sponsors
CMC AMBROISE PARE
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - > 18 years old, - Undergoing cardiac surgery with cardiopulmonary bypass, - Having signed a written informed consent form, - Affiliation to the social security system Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 150 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 150
Exclusion criteria
Exclusion criteria: - Allergy or known hypersensitivity to Naloxegol, - Pregnant or breastfeeding women - Severe hepatic failure, history of cirrhosis - Moderate or severe renal failure (GFR<30ml/min) - Concomitant treatment with a strong cytochrome P450 3A4 inhibitor - History of acute gastro-intestinal obstruction known or suspected - Clinically relevant alteration of the blood-brain-barrier - Cancer patient with increased risk of gastro-duodunal perforation - Disorder that could alter the integrity of the gastrointestinal lining - Regular treatment with laxative drugs - Concomitant treatment with methadone - Patients unabel 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Prove that the administration of Naloxegol in the perioperative period of cardiac surgery reduces the duration of the postoperative ileus.;Secondary Objective: 1-Demonstrate that the administration of Naloxegol decreases digestive complications. 2-Demonstrate that the administration of Naloxegol decreases respiratory complications (pneumonia, reintubation, length of ventilation) 3-Rate of infections complications 4-Verify the effectiveness of analgesia 5-Compare the length of hospital stay 6-Compare the duration of ICU stay;Primary end point(s): Time (hour) to transit recovry in postoperative of cardic surgery defined by the number of hour between the first anesthesic induction and the first bowel movement;Timepoint(s) of evaluation of this end point: 5 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. rate of digestive complications defined as: - intra-abdominal pressure - Ogilvie syndrome - vomiting - mesenteric ischemia - need of colonoscopy - placement nasogastic tube - solid food intolerance at day 2 2. rate of respiratory complications defined as: - duration (hours) of invasive ventilation then non –invasive ventilation - Reintubation - invasive or not invasive ventilation at day 2 - pneumonia defined. 3. rate of infections complications : Sepsis, sternal wound infection 4. Evaluation of pain with visual analogue scale (VAS) at day 1,2,3 and with post operative opioid consumption 5. Duration of hospital stay 6. Duration of ICU stay ;Timepoint(s) of evaluation of this end point: 30 days | — |
Countries
France
Contacts
Public Contactclinical trial information
CMC Ambroise Pare
Outcome results
None listed