Hydroxychloroquine and Cognitive Function After Surgery

  • STATUS
    Recruiting
  • End date
    Mar 22, 2023
  • participants needed
    30
  • sponsor
    Duke University
Updated on 22 March 2022

Summary

The purpose of this study is to determine whether hydroxychloroquine decreases the relative leakage of the brain barrier after surgery.

Description

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.

Details
Condition Individuals Undergoing Cardiac and General Surgery
Treatment hydroxychloroquine
Clinical Study IdentifierNCT03025087
SponsorDuke University
Last Modified on22 March 2022

Eligibility

Yes No Not Sure

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 and/or anxiety requiring medical treatment
Patients with impaired liver and/or kidney functions (AST, ALT 2 times the upper limit of normal)
Patients with impaired renal functions (GFR < 60ml/min)
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
Major ophthalmologic comorbidities (ex: ruptured globe, retinal vascular occlusive disease, retinal artery occlusion, anterior ischemic optic neuropathy, media opacification due to corneal abnormalities or cataract that prevent ocular and optical coherence tomography examination, glaucoma, age-related macular degeneration, history of intravitreal injections, and macular edema)
Patients who have received chemotherapy in the last 12 months
Patient with a QTc of 450 msec or greater (or 500 msec or greater in those with known IVCD, RBBB, or LBBB) at baseline will be excluded
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