CTIS2024-512004-19-01进行中（未招募）1 期
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
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 370
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •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
排除标准
- •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
研究者
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