SuspendedPhase 3

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

Stopped: interim analysis - Results ongoing

France370 participantsStarted 2022-03-15

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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

Exclusion criteria

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial is currently suspended — can you find out why it was paused and whether that raises any concerns about the safety or conduct of the study that would affect my care?
2This study is looking at whether naloxegol can help prevent constipation and gut slowdown in brain-injured patients on opioids — is gut motility already a concern in my treatment plan, and how is it being managed right now?
3One of the main outcomes this trial is tracking is ventilator-acquired pneumonia, which suggests these patients are on breathing machines — does my situation involve mechanical ventilation, and does that make this trial more or less relevant to my case?
4Since this is a Phase 3 trial, there's more safety data than earlier phases, but the suspension means something caused the researchers to pause — would you be able to review what's known so far about naloxegol's safety in brain-injured patients before we consider this option?
5Are there standard-of-care approaches already available for preventing opioid-induced gut problems in brain injury patients that I should consider first, rather than waiting to see if this suspended trial resumes?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Proportion of bowel movement

Timeframe: 6 days

Incidence of ventilator-acquired pneumonia

Timeframe: 7 days

Trial details

NCT IDNCT05008926

SponsorUniversity Hospital, Brest

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-10-26

View on ClinicalTrials.gov More Brain Injuries trials