Time to transit Recovery After treatment with Naloxegol in cardiac Surgery Intensive care Trial

Phase 1

• Conditions: ileus after cardiac surgery; MedDRA version: 20.0Level: LLTClassification code 10017501Term: Functional disturbances following cardiac surgerySystem Organ Class: 100000004863; MedDRA version: 20.1Level: LLTClassification code 10051798Term: Postoperative constipationSystem Organ Class: 100000004863; MedDRA version: 20.0Level: LLTClassification code 10071128Term: Opioid induced constipationSystem Organ Class: 100000004856; Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]

• Registration Number: EUCTR2020-000087-26-FR
• Lead Sponsor: CMC AMBROISE PARE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-02-26
• Last Update Posted: 8 June 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 300

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

-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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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. <br>2-Demonstrate that the administration of Naloxegol decreases respiratory complications (pneumonia, reintubation, length of ventilation)<br>3-Rate of infections complications<br>4-Verify the effectiveness of analgesia<br>5-Compare the length of hospital stay<br>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 Outcome Measures

Name	Time	Method
Secondary end point(s): 1. rate of digestive complications defined as:<br>- intra-abdominal pressure<br>- Ogilvie syndrome <br>- vomiting<br>- mesenteric ischemia <br>- need of colonoscopy<br>- placement nasogastic tube<br>- solid food intolerance at day 2<br><br>2. rate of respiratory complications defined as:<br>- duration (hours) of invasive ventilation then non –invasive ventilation<br>- Reintubation<br>- invasive or not invasive ventilation at day 2<br>- pneumonia defined. <br><br>3. rate of infections complications : Sepsis, sternal wound infection<br><br>4. Evaluation of pain with visual analogue scale (VAS) at day 1,2,3 and with post operative opioid consumption <br>5. Duration of hospital stay<br>6. Duration of ICU stay<br>;Timepoint(s) of evaluation of this end point: 30 days