Measuring Nimodipine Levels in Patients with Aneurysmal Subarachnoid Hemorrhage
Determination of Cerebral Nimodipine Concentrations Following Oral, Intra-venous and Intra-arterial Administration - a Descriptive Pharmacokinetic/Pharmacodynamics Study
This study is testing how different ways of giving nimodipine affect its levels in the blood and brain of patients with a type of brain bleed, to see how it might help protect their brain and improve their recovery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 95 Years |
| Sex | All |
| Sponsor | Medical University of Vienna Academic / other |
| Locations | 1 site (Vienna) |
| Trial ID | NCT04649398 on ClinicalTrials.gov |
What this trial studies
This observational study aims to measure the concentrations of nimodipine in the blood, cerebrospinal fluid, and brain tissue following different routes of administration (oral, intravenous, and intra-arterial) in patients with aneurysmal subarachnoid hemorrhage. The study will correlate these concentrations with measures of cerebral metabolism and oxygenation to better understand the drug's neuroprotective effects and potential risks. By investigating the pharmacokinetics of nimodipine, the study seeks to clarify the optimal dosing regimen for improving patient outcomes.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 years old who have experienced an aneurysmal subarachnoid hemorrhage and require intensive care with brain microdialysis.
Not a fit: Patients who have contraindications for nimodipine or do not require intensive care and microdialysis will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved dosing strategies for nimodipine, enhancing patient recovery and reducing the risk of delayed cerebral ischemia.
How similar studies have performed: While the approach of measuring drug concentrations in this context is not widely tested, previous studies have shown the importance of nimodipine in managing subarachnoid hemorrhage, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * patient age \> 18 years * aneurysmal subarachnoid hemorrhage * sedated and mechanically ventilated * application of brain microdialysis as standard care (due to the severity of subarachnoid haemorrhage or secondary deterioration) * oral, intra-venous or intra-arterial administration of nimodipine due to clinical indication Exclusion Criteria: * contraindication for nimodipine * no need of intensive care and bedside cerebral microdialysis as standard care * any disease considered relevant for proper performance of the study or risks to the patient, at the discretion of the investigator
Where this trial is running
Vienna
- Medical University of Vienna — Vienna, Austria (Recruiting)
Study contacts
- Study coordinator: Arthur Hosmann, MD PhD
- Email: arthur.hosmann@meduniwien.ac.at
- Phone: +43/1/40400
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.