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

CompletedPhase 2

Sponsor: University of Michigan

Conditions: Postoperative Delirium, Postoperative Cognitive Dysfunction, Mild Cognitive Impairment

Interventions: Dextrose Water, Caffeine citrate, Caffeine citrate

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 70 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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. Active carcinoid syndrome
12. Severe audiovisual impairment
13. Non-English speaking

Locations (1)

Ann Arbor, Michigan, United States