Mitigating Delirium With Fluvoxamine Treatment for Non-Cardiac Surgery

Official title

Mitigating Delirium With Fluvoxamine Treatment for Non-Cardiac Surgery (MD FluNCS)

Overview

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.

Interventions

• Drug Fluvoxamine
  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
• Drug Placebo
  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

Primary outcome measures

• Average Monthly participant enrollment rate [Time frame: 12- months, duration of the study]

Secondary outcome measures (2)

• Average Monthly screen failure rate [Time frame: 12- months, duration of the study]
• Average Monthly rate of withdrawal [Time frame: 12- months, duration of the study]

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Quadruple blind

Primary purpose

Prevention

Study locations

United States · 1 center

• Washington University School of Medicine/Barnes-Jewish Hospital — St Louis

Identifiers

NCT: NCT06969287 · 202411151 · R21AG086855

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗