The NIPA Study: a Randomized Double-blind Control Clinical Trial Naloxegol Administration to Prevent Opioids Induced Gastrointestinal Motility Disturbance in Brain Injured PAtients

Status: Recruiting
Location: See all (11) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age ≥ to 18 years old

• Admission to intensive care unit for traumatic brain injury or subarachnoid hemorrhage without other life-threatening injury

• Patients under sedation with administration of opiate-agonists, μ receptor agonists (Sufentanil, Fentanyl, Remifentanil, Morphine) for less than 24 hours

• Expected duration of invasive mechanical ventilation and sedation of 48 hours or more

• Intracranial pressure monitoring

• Enteral feeding by oro / nasogastric tube

• Affiliated or beneficiary of the French social security system

Locations
Other Locations
France
CHU Bordeaux
RECRUITING
Bordeaux
CHU de Bordeaux - Réanimation chirurgicale
NOT_YET_RECRUITING
Bordeaux
CHU Brest
RECRUITING
Brest
CHU Clermont-Ferrand
NOT_YET_RECRUITING
Clermont-ferrand
CHU de Lille
NOT_YET_RECRUITING
Lille
CHU de Montpellier
RECRUITING
Montpellier
CHU Nantes
RECRUITING
Nantes
Hôpital La Pitié Salpétrière (APHP)
RECRUITING
Paris
CHU de Strasbourg
ACTIVE_NOT_RECRUITING
Strasbourg
CHU Tours - Hôpital BRETONNEAU
ACTIVE_NOT_RECRUITING
Tours
CHU Tours - Hôpital TROUSSEAU
RECRUITING
Tours
Contact Information
Primary
Olivier Huet, PU-PH
olivier.huet@chu-brest.fr
+33 2 98 34 72 88
Backup
Philippe Aries, PH
philippe.aries@chu-brest.fr
+33 2 98 34 72 88
Time Frame
Start Date: 2022-03-15
Estimated Completion Date: 2026-04
Participants
Target number of participants: 370
Treatments
Experimental: 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.
Placebo_comparator: Placebo
Administration of the placebo according to the same procedures as the experimental arm.
Related Therapeutic Areas
Sponsors
Leads: University Hospital, Brest

This content was sourced from clinicaltrials.gov