The Caffeine, Postoperative Delirium, and Change in Outcomes After Surgery (CAPACHINOS-2) Study

HUM00218290

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.

2023-02-20

2026-04-30

2026-05-31

Recruiting

Early phase I

250

Inclusion Criteria: 1. Adult (\>/= 70 years old) undergoing non-cardiac, non-intracranial neurologic, non-major vascular surgery requiring general anesthesia with a planned admission for at least 48 hours. 2. Stated willingness to comply with all study procedures and availability for the duration of the study. 3. Provision of signed and dated informed consent form. Exclusion Criteria: 1. Emergency surgery 2. Outpatient surgery 3. Severe cognitive impairment precluding the capacity for informed consent 4. Seizure disorder history 5. Intolerance or allergy to caffeine (based on subjective reporting or objective documentation) 6. Weight \>130 kg (as a 3 mg/kg dose would approach the upper limit of daily intake recommended by the FDA) 7. Enrollment in conflicting research study 8. Patients in acute liver failure 9. Acute kidney injury preoperatively 10. Diagnosis of pheochromocytoma 11. Severe audiovisual impairment 12. Non-English speaking

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This will be a three-arm parallel trial.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'maskingDescription': 'This will be a single-center, quadruple-blinded, randomized control trial at Michigan Medicine', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 250, 'type': 'ESTIMATED'}}

2024-03-13