The Caffeine, Postoperative Delirium, and Change in Outcomes After Surgery (CAPACHINOS-2) Study
NCT05574400 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 250
Last updated 2026-04-21
Summary
The objective of this study is to test the effects of caffeine on neurocognitive and clinical recovery after major surgery. Specifically, this trial tests the primary hypothesis that caffeine will reduce the incidence of postoperative delirium.
Conditions
- Postoperative Delirium
- Postoperative Cognitive Dysfunction
- Mild Cognitive Impairment
Interventions
- DRUG
-
Dextrose Water
Dextrose 5% in water
- DRUG
-
Caffeine citrate
Low-dose caffeine citrate (1.5 mg/kg)
- DRUG
-
Caffeine citrate
High-dose Caffeine citrate (3 mg/kg)
Sponsors & Collaborators
-
National Institute on Aging (NIA)
collaborator NIH - lead OTHER
Principal Investigators
-
Phillip Vlisides, MD · Assistant Professor of Anesthesiology
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-02-20
- Primary Completion
- 2026-04-16
- Completion
- 2026-05-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
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