Using lithium to improve brain outcomes after carotid artery surgery
A Lithium-Based Medication to Improve Neurological Outcomes After Surgical Carotid Reconstruction: A Double-Blind, Placebo Control Randomized Trial (BINOS)
This study is testing if giving lithium to patients before carotid artery surgery can help protect their brains and reduce problems like confusion after the operation.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Negovsky Reanimatology Research Institute Government |
| Locations | 2 sites (Moscow and 1 other locations) |
| Trial ID | NCT05126238 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of lithium carbonate on neurological outcomes in patients undergoing elective carotid artery surgery. The study aims to determine if lithium can reduce the incidence of postoperative neurocognitive disorders, such as emergence delirium and cognitive dysfunction, which can occur due to temporary blood flow interruption during surgery. Participants will be randomly assigned to receive either lithium or a placebo prior to their surgery. The trial will assess the effectiveness of lithium in protecting the brain from ischemic damage during the surgical procedure.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old scheduled for elective carotid artery surgery under general anesthesia.
Not a fit: Patients with recent strokes, severe mental disorders, or significant heart or kidney issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve recovery and cognitive outcomes for patients undergoing carotid artery surgery.
How similar studies have performed: Previous studies have shown that lithium may reduce stroke volume, suggesting potential benefits in similar contexts, though this specific application is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * age \> 18 years * elective carotid artery surgery * general anesthesia * written informed consent Exclusion Criteria: * urgent surgery * recent ( \< 1 month) overt stroke * Mini-mental State Examination \< 20 points * The presence of any mental disorder according to the International Classification of Diseases 11th Revision which is confirmed by a psychiatrist. * The presence of any neuromuscular disease according to the International Classification of Diseases 11th Revision * Hypersensitivity or known allergy to lithium carbonate * History of seizure disorder * History of leukemia * Estimated glomerular filtration rate \< 30 ml/min/1.73 m2 * Left ventricular ejection fraction \< 30% * Heart failure equal 3 or 4 class according to the New York Heart Association Functional Classification * Pregnant or breast-feeding women * Inability to undergo a preoperative assessment for any reason * Previously enrolled in this trial
Where this trial is running
Moscow and 1 other locations
- Vishnevsky Center of Surgery — Moscow, Russian Federation (Recruiting)
- Demikhov Municipal Clinical Hospital 68 — Moscow, Russian Federation (Recruiting)
Study contacts
- Principal investigator: Valery Likhvantsev, PhD — Negovsky Reanimatology Research Institute
- Study coordinator: Valery Likhvantsev, PhD
- Email: lik0704@gmail.com
- Phone: +79036235982
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.