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Hydroxychloroquine and Cognitive Function After Surgery (NCT03025087)

The purpose of this study is to determine whether hydroxychloroquine decreases the relative leakage of the brain barrier after surgery.
  • Drug: Hydroxychloroquine
    Participants will be getting hydroxychloroquine
    Ages eligible for Study
    50 Years and older
    Genders eligible for Study
    All
    Accepts Healthy Volunteers
    No
    Inclusion Criteria:
    • Male or female, age ≥ 50 years old.
    • Patients scheduled to undergo cardiac surgery (CABG, CABG + Valve, Valve) with CPB or general surgery (e.g. orthopedic, abdominal, urological).
    • 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:
    • Cardiac surgery scheduled to be performed without cardiopulmonary bypass
    • Patients requiring emergent operation
    • Patients with a history of myocardial infarction within 7 days of surgery
    • Patients with a history of porphyria, psoriasis, chronic dermatitis, or retinal disease
    • Patients receiving preoperative digoxin
    • Patients with symptomatic cerebrovascular disease with substantial residual deficit
    • Patients with a history of alcohol abuse within 2 years of screening
    • Patients with history of psychiatric illness
    • 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
    • Patients with less than a 7th grade education or unable to read and thus unable complete the neuropsychological testing
    • Patients scoring < 26 on a baseline Mini Mental State examination (MMSE) or scoring >27 on the Center for Epidemiological Studies - Depression (CES-D) scale
    • Female subjects of childbearing potential who have had menstrual period within the past two years
    • Patients with bodily implants unsafe for MRI use
    • Patients with a history of claustrophobia
    • Known or suspected hypersensitivity to quinine (chloroquine or hydroxychloroquine)
    • Patient with pre-existing diagnosis of G6PD deficiency
    • Patients who have participated in another interventional clinical study within the previous 30 days
    • Any other concurrent disease or illness that, in the opinion of the investigator, makes the patient unsuitable for the study
    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.
    Status:
    not yet recruiting
    Type:
    Interventional
    Phase:
    Start:
    31 May, 2017
    Updated:
    08 May, 2017
    Participants:
    30
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