|
The Caffeine, Postoperative Delirium, and Change in Outcomes After Surgery (CAPACHINOS-2) Study
RECRUITINGPhase 2Sponsored by University of Michigan
Actively Recruiting
PhasePhase 2
SponsorUniversity of Michigan
Started2023-02-20
Est. completion2026-04-30
Eligibility
Age70 Years+
Healthy vol.Accepted
Locations1 site
View on ClinicalTrials.gov →
NCT05574400
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.
Eligibility
Age: 70 Years+Healthy volunteers accepted
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
Conditions4
Alzheimer's DiseaseMild Cognitive ImpairmentPostoperative Cognitive DysfunctionPostoperative Delirium
Locations1 site
Browse More Trials
Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.
This site does not provide medical advice. Always consult your doctor before considering enrollment in a clinical trial. Learn more on our About page.
Actively Recruiting
PhasePhase 2
SponsorUniversity of Michigan
Started2023-02-20
Est. completion2026-04-30
Eligibility
Age70 Years+
Healthy vol.Accepted
Locations1 site
View on ClinicalTrials.gov →
NCT05574400