RECRUITING

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

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Conditions

Postoperative DeliriumPostoperative Cognitive DysfunctionMild Cognitive ImpairmentNeurocognitive DisordersAlzheimer's Disease

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-02-20
Study Completion:2026-05-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05574400

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:70 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 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. 2. Stated willingness to comply with all study procedures and availability for the duration of the study.
  3. 3. Provision of signed and dated informed consent form.
  1. 1. Emergency surgery
  2. 2. Outpatient surgery
  3. 3. Severe cognitive impairment precluding the capacity for informed consent
  4. 4. Seizure disorder history
  5. 5. Intolerance or allergy to caffeine (based on subjective reporting or objective documentation)
  6. 6. Weight \>130 kg (as a 3 mg/kg dose would approach the upper limit of daily intake recommended by the FDA)
  7. 7. Enrollment in conflicting research study
  8. 8. Patients in acute liver failure
  9. 9. Acute kidney injury preoperatively
  10. 10. Diagnosis of pheochromocytoma
  11. 11. Severe audiovisual impairment
  12. 12. Non-English speaking

Contacts and Locations

Study Contact

Phillip Vlisides, MD
CONTACT
(734) 936-4280
pvliside@umich.edu
Amy McKinney, MA
CONTACT
(734) 647-8129
adrongo@umich.edu

Principal Investigator

Phillip Vlisides, MD
PRINCIPAL_INVESTIGATOR
Assistant Professor of Anesthesiology

Study Locations (Sites)

Michigan Medicine
Ann Arbor, Michigan, 48109
United States

Collaborators and Investigators

Sponsor: University of Michigan

  • Phillip Vlisides, MD, PRINCIPAL_INVESTIGATOR, Assistant Professor of Anesthesiology

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-02-20
Study Completion Date2026-05-31

Study Record Updates

Study Start Date2023-02-20
Study Completion Date2026-05-31

Terms related to this study

Keywords Provided by Researchers

  • Postoperative Delirium
  • Neurocognitive Disorders
  • Mild Cognitive Impairment
  • Alzheimer's Disease

Additional Relevant MeSH Terms

  • Postoperative Delirium
  • Postoperative Cognitive Dysfunction
  • Mild Cognitive Impairment