Hydroxychloroquine and Cognitive Function After Surgery
Status: | Recruiting |
---|---|
Healthy: | No |
Age Range: | 50 - Any |
Updated: | 6/29/2018 |
Start Date: | June 19, 2017 |
End Date: | March 2020 |
Contact: | Tiffany L Bisanar, RN, BSN |
Email: | tiffany.bisanar@duke.edu |
Phone: | 919-681-0866 |
The purpose of this study is to determine whether hydroxychloroquine decreases the relative
leakage of the brain barrier after surgery.
leakage of the brain barrier after surgery.
Hydroxychloroquine will be administered preoperatively to 30 patients undergoing cardiac or
noncardiac surgery. All patients will undergo magnetic resonance imaging (MRI) with
gadolinium in the post-operative period before hospital discharge in order to assess blood
brain barrier permeability.
noncardiac surgery. All patients will undergo magnetic resonance imaging (MRI) with
gadolinium in the post-operative period before hospital discharge in order to assess blood
brain barrier permeability.
Inclusion Criteria:
1. Male or female, age ≥ 50 years old.
2. Patients scheduled to undergo cardiac surgery (CABG, CABG + Valve, Valve) with CPB or
general surgery (e.g. orthopedic, abdominal, urological).
3. Patient has voluntarily signed and dated the study-specific informed consent form
approved by Duke University Health System Institutional Review Board (DUHS IRB)
Exclusion Criteria:
1. Cardiac surgery scheduled to be performed without cardiopulmonary bypass
2. Patients requiring emergent operation
3. Patients with a history of myocardial infarction within 7 days of surgery
4. Patients with a history of porphyria, psoriasis, chronic dermatitis, or retinal
disease
5. Patients receiving preoperative digoxin
6. Patients with symptomatic cerebrovascular disease with substantial residual deficit
7. Patients with a history of alcohol abuse within 2 years of screening
8. Patients with history of psychiatric illness
9. Patients with impaired liver and/or kidney functions (AST, ALT 2 times the upper limit
of normal and/or serum creatinine of more than 2.0 mg/dl
10. Patients with less than a 7th grade education or unable to read and thus unable
complete the neuropsychological testing
11. Patients scoring < 26 on a baseline Mini Mental State examination (MMSE) or scoring
>27 on the Center for Epidemiological Studies - Depression (CES-D) scale
12. Female subjects of childbearing potential who have had menstrual period within the
past two years
13. Patients with bodily implants unsafe for MRI use
14. Patients with a history of claustrophobia
15. Known or suspected hypersensitivity to quinine (chloroquine or hydroxychloroquine)
16. Patient with pre-existing diagnosis of G6PD deficiency
17. Patients who have participated in another interventional clinical study within the
previous 30 days
18. Any other concurrent disease or illness that, in the opinion of the investigator,
makes the patient unsuitable for the study
We found this trial at
1
site
Durham, North Carolina 27710
Principal Investigator: Joseph P Mathew, MD
Phone: 919-681-0866
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