The NIPA Study Naloxegol Administration to Prevent Opioids Induced Gastrointestinal Motility Disturbance in Brain Injured PAtients (NIPA)

  • End date
    Apr 13, 2024
  • participants needed
  • sponsor
    University Hospital, Brest
Updated on 13 April 2022
mechanical ventilation


Impaired gastrointestinal transit (IGT) especially constipation, is common among patients under mechanical ventilation, occurring in up to 80 % of the patients during the first week, and has been associated with worse outcome in intensive care unit (ICU). Although IGT in critically ill patients is multifactorial and some components are due to complex disease, there is increasing evidence that exogenous opioids contribute to bowel dysmotility.

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.


Multicenter, randomized, double-blind, placebo-controlled experimental study of Naloxegol.

Condition Brain Injuries
Treatment Placebo, Naloxegol
Clinical Study IdentifierNCT05008926
SponsorUniversity Hospital, Brest
Last Modified on13 April 2022


Yes No Not Sure

Inclusion Criteria

intracranial hypertension requiring therapy other than analgo-sedation (thiopental, targeted temperature management, decompressive craniectomy)
Acute or chronic renal failure with creatinine clearance <60ml / min
Known or suspected acute gastrointestinal obstruction
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
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)
Concomitant treatment with vascular endothelial growth factor (VEGF) inhibitor
Allergy to Naloxegol or one of its excipients
Recent history of myocardial infarction within the past 6 months, symptomatic congestive cardiovascular disease, QT ≥ 500 msec
Patient with a medical decision for rapid palliative care
Pregnancy and / or breastfeeding
Child Pugh C stage cirrhosis
Patient under legal protection or deprived of liberty
Patient with another life-threatening injury
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

Exclusion Criteria

Patient who received opioids for more than 24 hours
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