CTIS2024-512004-19-01Active, not recruitingPhase 1
The NIPA study: A randomized double-blind control clinical trial Naloxegol administration to prevent opioids induced gastrointestinal motility disturbance in brain Injured PAtients. - 2019-000959-14
Centre Hospitalier Regional Et Universitaire De Brest0 sites370 target enrollmentStarted: April 23, 2024Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Enrollment
- 370
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 65+ (—)
- Sex
- All
Inclusion Criteria
- •Age = 18 years, Intensive care unit admission for head trauma or subarachnoid hemorrhage without other life-threatening injury, Sedation for neuro-protective purposes with administration of morphinomimetics (µ-receptor agonists) IVSE (Sufentanil, Fentanyl, Remifentanil, Morphine) for less than 24 hours, Duration of invasive mechanical ventilation and sedation estimated at 48 hours minimum, Intracranial pressure monitoring planned, Enteral feeding via oro/nasogastric tube planned, Affiliated with or benefiting from a social security scheme
Exclusion Criteria
- •Patient having received morphine for sedation for more than 24 hours, Patient with medical decision for rapid palliative management, Pregnancy and/or breast-feeding, Cirrhosis Child Pugh C stage, Patient under legal protection (guardianship, curatorship or unable to express consent prior to current hospitalization) or deprived of liberty, Patient with other life-threatening injury (other than acute brain injury), History of clinically significant alterations to the blood-brain barrier: primary brain tumors, metastases or other inflammatory pathologies in the CNS, active multiple sclerosis, advanced Alzheimer's disease., Patient with refractory HTIC at the time of inclusion: HTIC requiring therapies other than analgesia (thiopental, targeted temperature control, decompression craniectomy), Acute or chronic renal failure with creatinine clearance < 60ml/min, Known or suspected acute gastrointestinal obstruction (occlusive syndrome), Risk of digestive perforation: - history or presence of peptic ulcer disease - Crohn's disease - ogilvie syndrome - acute diverticulitis - infiltrating gastrointestinal tumour - recurrent or advanced ovarian cancer - peritoneal metastasis - recent abdominal trauma with risk of digestive perforation, Concomitant treatment with strong or moderate CYP3A4 inhibitors (e.g. clarithromycin, ketaconazole, itraconazole, telithromycin, ritonavir, indinavir, saquinavir) or strong inducers (carbamazepine, rifampicin, St. John's wort), Concomitant treatment with a vascular endothelial growth factor (VEGF) inhibitor., Allergy to Naloxegol or any of its excipients, Recent history of myocardial infarction within the last 6 months, symptomatic congestive cardiovascular disease, QT = 500 msec
Investigators
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