Mitigating Delirium With Fluvoxamine Treatment for Non-Cardiac Surgery (MD FluNCS)
Overview
- Phase
- Phase 3
- Intervention
- Fluvoxamine
- Conditions
- Not specified
- Sponsor
- Washington University School of Medicine
- Enrollment
- 46
- Locations
- 2
- Primary Endpoint
- Average Monthly participant enrollment rate
- Status
- Recruiting
- Last Updated
- 11 days ago
Overview
Brief 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.
Detailed 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 pathogenesis of postoperative delirium, a matter of conjecture. The investigators will directly test systemic inflammation as a proxy for neuroinflammation. The investigation will test whether fluvoxamine may be associated with reduced systemic inflammation, markers of neural dysfunction, and delirium severity. This potential therapeutic approach has potential generalizability to different clinical settings and already proved useful for COVID-19. The investigators combine the need to develop a collaborative clinical trials platform across diverse healthcare settings with key mechanistic studies that will advance our understanding of the pathogenesis of delirium. These studies will leverage high-density EEG recordings and state-of-the-art plasma biomarker collection, providing key data on the biological plausibility for a fluvoxamine effect.
Investigators
Eligibility Criteria
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)
Arms & Interventions
Fluvoxamine
100 mg of fluvoxamine on the morning of surgery (POD 0), 100 mg on the evening of surgery (POD 0), 100 mg on the morning of POD 1, and 100 mg on the evening of POD 1. All administered as PO capsules.
Intervention: Fluvoxamine
Placebo
Placebo capsule on the morning of surgery (POD 0), Placebo capsule on the evening of surgery (POD 0), Placebo capsule on the morning of POD 1, and Placebo capsule on the evening of POD 1. All administered PO.
Intervention: Placebo
Outcomes
Primary Outcomes
Average Monthly participant enrollment rate
Time Frame: 12- months, duration of the study
Feasibility assessed as number of eligible participants enrolled per month by an audit of the study screening and recruitment logs.
Secondary Outcomes
- Average Monthly screen failure rate(12- months, duration of the study)
- Average Monthly rate of withdrawal(12- months, duration of the study)
- Average Monthly screen failure rate(12- months, duration of the study)
- Average Monthly rate of withdrawal(12- months, duration of the study)