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The NIPA study: A randomized double-blind control clinical trial Naloxegol administration to prevent opioids induced gastrointestinal motility disturbance in brain Injured PAtients.
EU CTIS ID: 2024-512004-19-01
What this study is testing
To evaluate the efficacy of naloxegol administration on the occurrence of early constipation and on the incidence of early ventilator-associated pneumonitis.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- 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)
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.