Mitigating Delirium With Fluvoxamine Treatment for Non-Cardiac Surgery (MD FluNCS)
Washington University School of Medicine
Summary
The investigation will establish biological plausibility and infrastructure required for a multisite clinical trial evaluating the re-purposing of fluvoxamine to mitigate postoperative delirium risk in geriatric patients undergoing non-cardiac non-intracranial surgery.
Description
Delirium is a disturbance in attention, cognition, and consciousness, an acute physiological consequence of medical events, such as hospital admission, surgery, sepsis, and pharmacological intervention. There are currently no standard pharmacologic interventions to prevent delirium in any setting. The investigation will lay the groundwork for a larger-scale Phase 3 trial geared toward advancing long-term goal of improving public health and quality of life for those at risk of postoperative delirium and related sequelae. The study assumes that neuroinflammation is a key contributor to the path…
Eligibility
- Age range
- 60+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * English-speaking * elective non-cardiac or non-intracranial surgery requiring at least a 2-day hospital length of stay Exclusion Criteria: * Received investigational drug within the last 7 weeks * lack of capacity to provide informed consent * prior known intolerance or allergy to SSRIs or fluvoxamine * planned postoperative ventilation * drug or alcohol dependence * preoperative use of non-NSAID medications with drug-drug interactions of Class X (Avoid Combination) or D (Consider Therapy Modification) * risk of serotonin syndrome (St John's Wort, SSRIs, or TCA)
Interventions
- DrugFluvoxamine
100mg Fluvoxamine Capsule 1. Day of surgery - Study drug to be taken morning of surgery and evening of surgery 2. Post-operative day 1 - Study drug to be taken morning and evening
- DrugPlacebo
Placebo Capsule 1. Day of surgery - Study drug to be taken morning of surgery and evening of surgery 2. Post-operative day 1 - Study drug to be taken morning and evening
Location
- Washington University School of Medicine/Barnes-Jewish HospitalSt Louis, Missouri