Naloxegol to prevent gastrointestinal issues in brain-injured patients
The NIPA Study: A Randomized Double-blind Control Clinical Trial Naloxegol Administration to Prevent Opioids Induced Gastrointestinal Motility Disturbance in Brain Injured PAtients
This study is testing if Naloxegol can help prevent constipation and related problems in patients with brain injuries who are on sedation and breathing machines.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 370 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Brest Academic / other |
| Locations | 11 sites (Bordeaux, France and 10 other locations) |
| Trial ID | NCT05008926 on ClinicalTrials.gov |
What this trial studies
This multicenter, randomized, double-blind, placebo-controlled study investigates the use of Naloxegol to prevent impaired gastrointestinal transit (IGT) in patients with traumatic brain injuries or subarachnoid hemorrhage who are under sedation and mechanical ventilation. Given the high incidence of constipation and related complications in this population, the study aims to assess whether Naloxegol can effectively mitigate these issues before they arise. Participants will receive either Naloxegol or a placebo while being monitored for gastrointestinal motility disturbances. The study is designed to provide insights into improving outcomes for critically ill patients in intensive care units.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are admitted to the ICU for traumatic brain injury or subarachnoid hemorrhage and require sedation with opioids for less than 24 hours.
Not a fit: Patients who have received opioids for more than 24 hours or have refractory intracranial hypertension may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly improve gastrointestinal health and overall outcomes for brain-injured patients in intensive care.
How similar studies have performed: While the approach of using Naloxegol in this specific patient population is novel, similar studies have shown promise in addressing gastrointestinal motility issues in critically ill patients.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age ≥ to 18 years old 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: 1. Patient who received opioids for more than 24 hours 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.
Where this trial is running
Bordeaux, France and 10 other locations
- CHU de Bordeaux - Réanimation chirurgicale — Bordeaux, France, France (Not_yet_recruiting)
- CHU Bordeaux — Bordeaux, France (Recruiting)
- CHU Brest — Brest, France (Recruiting)
- CHU Clermont-Ferrand — Clermont-Ferrand, France (Not_yet_recruiting)
- CHU de Lille — Lille, France (Not_yet_recruiting)
- CHU de Montpellier — Montpellier, France (Recruiting)
- CHU Nantes — Nantes, France (Recruiting)
- Hôpital La Pitié Salpétrière (APHP) — Paris, France (Recruiting)
- CHU de Strasbourg — Strasbourg, France (Active_not_recruiting)
- CHU Tours - Hôpital BRETONNEAU — Tours, France (Active_not_recruiting)
- CHU Tours - Hôpital TROUSSEAU — Tours, France (Recruiting)
Study contacts
- Principal investigator: Olivier Huet, PU-PH — CHU Brest
- Study coordinator: Olivier Huet, PU-PH
- Email: olivier.huet@chu-brest.fr
- Phone: +33 2 98 34 72 88
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.