Effects of caffeine on recovery after major surgery
The Caffeine, Postoperative Delirium, and Change in Outcomes After Surgery (CAPACHINOS-2) Study
This study is testing if giving caffeine to older adults after major surgery can help them recover better and reduce the chances of experiencing confusion or delirium.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 250 (estimated) |
| Ages | 70 Years and up |
| Sex | All |
| Sponsor | University of Michigan Academic / other |
| Locations | 1 site (Ann Arbor, Michigan) |
| Trial ID | NCT05574400 on ClinicalTrials.gov |
What this trial studies
This study investigates how caffeine affects neurocognitive recovery and the incidence of postoperative delirium in older adults undergoing major surgery. It aims to determine if caffeine can reduce the occurrence of delirium, which is common in older surgical patients and linked to severe complications. The trial will involve administering caffeine citrate to participants and monitoring their cognitive and clinical outcomes post-surgery. The research is based on the premise that caffeine may enhance cognitive function and improve recovery by optimizing brain activity.
Who should consider this trial
Good fit: Ideal candidates are adults aged 70 and older undergoing non-cardiac surgery requiring general anesthesia with a planned hospital stay of at least 48 hours.
Not a fit: Patients undergoing emergency or outpatient surgery, or those with severe cognitive impairment or contraindications to caffeine, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved recovery outcomes and reduced incidence of postoperative delirium in older surgical patients.
How similar studies have performed: While caffeine has been explored in various contexts, this specific approach to reducing postoperative delirium in older adults is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Ann Arbor, Michigan
- Michigan Medicine — Ann Arbor, Michigan, United States (Recruiting)
Study contacts
- Principal investigator: Phillip Vlisides, MD — Assistant Professor of Anesthesiology
- Study coordinator: Phillip Vlisides, MD
- Email: pvliside@umich.edu
- Phone: (734) 936-4280
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.