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

• Status: Not yet recruiting
• Trial end date: 2026-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Michigan
• Collaborator: National Institute on Aging (NIA)
• Treatments: Caffeine; Caffeine citrate; Citric Acid; Sodium Citrate

Criteria

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