Examining blood flow interactions in brain-injured patients under anesthesia or intensive care
Analysis of the Macro-microcirculatory Coupling in the Course of Using the Vasoactive Substances During Anesthesia-resuscitation of Brain-damaged Patients
This study is testing how different medications that affect blood flow can help improve blood circulation in the brains of patients with severe brain injuries who are under anesthesia or in intensive care.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 85 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 1 site (Paris) |
| Trial ID | NCT05285514 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on patients with severe brain injuries who require careful management of blood pressure during anesthesia or intensive care. It aims to investigate the effects of vasoactive agents on both macro- and microcirculatory parameters to ensure optimal cerebral perfusion pressure (CPP) and organ perfusion. By integrating the impact of these agents on microcirculation, the study seeks to improve patient management strategies in critical care settings. The research will involve monitoring hemodynamic parameters and assessing the microcirculatory response to various treatments.
Who should consider this trial
Good fit: Ideal candidates include adult patients aged 18 and older with brain damage who require general anesthesia or resuscitation and have blood pressure issues necessitating vasoactive agents.
Not a fit: Patients under 18, pregnant women, or those unable to consent will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management of blood pressure and better outcomes for patients with severe brain injuries.
How similar studies have performed: While the study explores a relatively under-researched area, similar studies have shown the importance of microcirculation in critical care, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult patients (≥ 18 years old) * With brain damage * Benefiting from general anesthesia or resuscitation justifying the placement of an arterial catheter and monitoring of cardiac output * With hypotension or arterial hypertension requiring intravenous administration of a vasoactive agent to meet the target cerebral perfusion pressure (CPP) of 60-70 mmHg * Not subject to a measure of legal protection (tutorship/curatorship) * Patients informed and having expressed their non-objection to participation in this research, or, where applicable, a person of trust / family member / relative of the patient who is unable to express her or his agreement Exclusion Criteria: * Patients under the age of 18 * Pregnant woman * Patient without affiliation to a social security scheme * Patient, or, where applicable, person of trust / family member / relative of the patient unable to express her or his agreement, opposed to participation in the study * Patient subject to a legal protection measure * Patient benefiting from the State medical assistance (AME) program
Where this trial is running
Paris
- AP-HP, Lariboisière Hospital, Department of Anesthesiology and Intensive Care — Paris, France (Recruiting)
Study contacts
- Principal investigator: Fabrice VALLEE, MD, PhD — AP-HP, Lariboisière Hospital, Department of Anesthesiology and Intensive Care
- Study coordinator: Joaquim MATEO, MD
- Email: joaquim.mateo@aphp.fr
- Phone: +33 (0)1 49 95 83 74
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.