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

Launched by UNIVERSITY HOSPITAL, BREST · Aug 16, 2021

Keywords

ClinConnect Summary

The NIPA Study is a clinical trial that is looking at how well a medication called naloxegol can help prevent constipation and other gastrointestinal issues in patients with brain injuries who are receiving opioids for pain relief. Constipation is a common problem for patients on mechanical ventilation, and it can lead to serious complications like pneumonia and infections. By using naloxegol, which works on the gut without affecting sedation, researchers hope to improve the comfort and recovery of these patients in the intensive care unit (ICU).

To be eligible for this study, participants must be at least 18 years old, admitted to the ICU for specific types of brain injuries, and receiving opioids for a short time (less than 24 hours). They should also be expected to need mechanical ventilation and sedation for at least 48 hours. If someone joins the study, they will receive naloxegol along with regular care, and the team will monitor how well it helps prevent constipation and related complications. It's important to note that certain medical conditions may exclude someone from participating, so those interested should discuss it with their healthcare provider.

Gender

ALL

Eligibility 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.