The NIPA Study Naloxegol Administration to Prevent Opioids Induced Gastrointestinal Motility Disturbance in Brain Injured PAtients
NCT ID: NCT05008926
Last Updated: 2025-11-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
370 participants
INTERVENTIONAL
2022-03-15
2026-09-15
Brief Summary
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Sedatives and especially opioids are largely used in the brain injured population to control intracranial pression, reduce metabolic rate, manage or prevent seizures, and improve mechanical ventilator synchrony. Therefore, brain injured patients are particularly at risk to develop IGT. The occurrence of IGT is associated with adverse outcomes in intensive care unit. Both gastric reflux and impaired peristaltic contractions are associated with ventilator-acquired pneumonia.
The actual challenge is to prevent motility disorders before it occurs. A preventive strategy could in turn reduce the occurrence of complications related to impaired gastrointestinal transit such as ventilator-acquired pneumonia, bacteremia etc. It could also reduce the complications of feed intolerance and thus reduce morbidity and mortality in ICU.
Naloxegol is a polyethylene glycol derivative of naloxol, which is a derivative of naloxone and a peripherally acting µ-opioid receptor antagonist. Contrary to naloxone, naloxegol has a very low penetration into the central nervous system, therefore it could be a relevant option for ileus prevention without the risk of impaired sedation.
The aim of our study is to assess the efficacy of the administration of naloxegol on the onset of early constipation and early ventilator-acquired pneumonia in brain injured patients receiving opioids for analgosedation.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Naloxegol
Administration of Naloxegol 25 mg per day by nasogastric tube (NG) or orogastric tube (OG). The administration should be started within the first 24 hours after the patient is admitted to intensive care unit and continued for the duration of the administration of the morphine derivative and until 48 hours after its discontinuation.
Management of constipation and gastroparesis according to the recommendations.
Naloxegol
Administration of Naloxegol 25 mg per day by nasogastric tube (SNG) or orogastric tube (SOG). The administration should be started within the first 24 hours after the patient is admitted to intensive care and continued for the duration of the administration of the morphine derivative and until 48 hours after its discontinuation.
Placebo
Administration of the placebo according to the same procedures as the experimental arm.
Placebo
Administration of the placebo according to the same procedures as the experimental arm.
Interventions
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Naloxegol
Administration of Naloxegol 25 mg per day by nasogastric tube (SNG) or orogastric tube (SOG). The administration should be started within the first 24 hours after the patient is admitted to intensive care and continued for the duration of the administration of the morphine derivative and until 48 hours after its discontinuation.
Placebo
Administration of the placebo according to the same procedures as the experimental arm.
Eligibility Criteria
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Inclusion Criteria
2. Admission to intensive care unit for traumatic brain injury or subarachnoid hemorrhage without other life-threatening injury
3. Patients under sedation with administration of opiate-agonists, μ receptor agonists (Sufentanil, Fentanyl, Remifentanil, Morphine) for less than 24 hours
4. Expected duration of invasive mechanical ventilation and sedation of 48 hours or more
5. Intracranial pressure monitoring
6. Enteral feeding by oro / nasogastric tube
7. Affiliated or beneficiary of the French social security system
Exclusion Criteria
2. Patient with refractory intracranial hypertension at the time of inclusion: intracranial hypertension requiring therapy other than analgo-sedation (thiopental, targeted temperature management, decompressive craniectomy)
3. Acute or chronic renal failure with creatinine clearance \<60ml / min
4. Known or suspected acute gastrointestinal obstruction
5. Risk of digestive perforation:
* history of peptic ulcer
* Crohn's disease
* Ogilvie syndrome
* acute diverticulitis
* infiltrating gastrointestinal tumor
* recurrent or advanced ovarian cancer
* peritoneal metastasis
* recent abdominal trauma with risk of digestive perforation
6. Concomitant treatment with a strong or moderate inhibitory effect of CYP 3A4 (For example: clarithromycin, ketaconazole, itraconazole, telithromycin, ritonavir, indinavir, saquinavir) or with a strong inducing effect (carbamazepin, rifampicin, millepertuis)
7. Concomitant treatment with vascular endothelial growth factor (VEGF) inhibitor
8. Allergy to Naloxegol or one of its excipients
9. Recent history of myocardial infarction within the past 6 months, symptomatic congestive cardiovascular disease, QT ≥ 500 msec
10. Patient with a medical decision for rapid palliative care
11. Pregnancy and / or breastfeeding
12. Child Pugh C stage cirrhosis
13. Patient under legal protection or deprived of liberty
14. Patient with another life-threatening injury
15. History of clinically important alterations of the blood-brain barrier: primary brain tumors, metastasis or other inflammatory pathologies in the CNS, active multiple sclerosis, Alzheimer's disease at an advanced stage.
18 Years
ALL
No
Sponsors
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University Hospital, Brest
OTHER
Responsible Party
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Principal Investigators
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Olivier Huet, PU-PH
Role: PRINCIPAL_INVESTIGATOR
CHU Brest
Locations
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CHU de Bordeaux - Réanimation chirurgicale
Bordeaux, France, France
CHU Bordeaux
Bordeaux, , France
CHU Brest
Brest, , France
CHU Clermont-Ferrand
Clermont-Ferrand, , France
CHU de Lille
Lille, , France
CHU de Montpellier
Montpellier, , France
CHU Nantes
Nantes, , France
Hôpital La Pitié Salpétrière (APHP)
Paris, , France
CHU de Strasbourg
Strasbourg, , France
CHU Tours - Hôpital BRETONNEAU
Tours, , France
CHU Tours - Hôpital TROUSSEAU
Tours, , France
Countries
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Central Contacts
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Facility Contacts
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Hugues De Courson, PH
Role: primary
Philippe Aries, PH
Role: primary
Russell Chabanne, PH
Role: primary
Yannick Hourmant, PH
Role: primary
Vincent Degos, PU-PH
Role: primary
Other Identifiers
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29BRC18.0262 (NIPA)
Identifier Type: -
Identifier Source: org_study_id
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