ClinicalTrials.gg
TerminatedNCT03025087Updated Aug 20, 2024Results posted

Hydroxychloroquine and Cognitive Function After Surgery

A Phase 4 interventional study of Hydroxychloroquine in Individuals Undergoing Cardiac and General Surgery, sponsored by Duke University. Terminated at 1 site in United States. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2024-08-20.

Sponsored by Duke University · Phase 4, Interventional, and Treatment

Why this study was terminated
Showed no benefit
Phase
Phase 4
Study type
Interventional
Enrollment
24
Allocation
Non-randomized
Ages
50 Years and older
Sex
All
01

Study summary

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

Read the detailed description

Hydroxychloroquine will be administered preoperatively to 30 patients undergoing cardiac 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.

02

Conditions studied

  • Individuals Undergoing Cardiac and General Surgery
03

In context

Lead sponsor

Duke University is the lead sponsor of 2,058 studies on the registry; 274 are open to participants now.

Of its 204 completed or terminated interventional studies of FDA-regulated products, 165 (81%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Male or female, age ≥ 50 years old.
  2. Patients scheduled to undergo cardiac surgery (CABG, CABG + Valve, Valve) with CPB.
  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

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 a history of psychiatric illness and/or anxiety requiring medical treatment.
  9. Patients with impaired liver and/or kidney functions (AST, ALT 2 times the upper limit of normal)
  10. Patients with impaired renal functions (GFR \< 30ml/min)
  11. Patients with less than a 7th-grade education or unable to read and thus unable complete the neuropsychological testing
  12. Patients scoring \< 26 on a baseline Mini Mental State examination (MMSE) or scoring >27 on the Center for Epidemiological Studies - Depression (CES-D) scale
  13. Female subjects of childbearing potential who have had menstrual period within the past two years
  14. Patients with bodily implants unsafe for MRI use
  15. Patients with a history of claustrophobia
  16. Known or suspected hypersensitivity to quinine (chloroquine or hydroxychloroquine)
  17. Patient with pre-existing diagnosis of G6PD deficiency
  18. Patients who have participated in another interventional clinical study within the previous 30 days
  19. Any other concurrent disease or illness that, in the opinion of the investigator, makes the patient unsuitable for the study
  20. 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)
  21. Patients who have received chemotherapy in the last 12 months
  22. 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.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
24 participants (actual)

Study arms

  • Experimental
    Phase 1

    6 evaluable subjects (3 cardiac, 3 noncardiac patients): 1000 mg HCQ on the day prior to surgery.

    Drug: Hydroxychloroquine

  • Experimental
    Phase 2

    6 evaluable subjects (3 cardiac, 3 noncardiac patients): 1000 mg HCQ on the day prior to surgery followed by 400 mg daily until the day of MRI imaging on postoperative day 1-5

    Drug: Hydroxychloroquine

  • Experimental
    Phase 3

    6 evaluable cardiac subjects 1000 mg HCQ on the day prior to surgery followed by 400 mg twice daily (800 mg total) until the day of MRI imaging on postoperative day 1-5.

    Drug: Hydroxychloroquine

  • Experimental
    Phase 4

    6 evaluable cardiac subjects: 1000 mg HCQ on the day prior to surgery followed by 500 mg twice daily (1000 mg total) until the day of MRI imaging on postoperative day 1-5.

    Drug: Hydroxychloroquine

  • Experimental
    Phase 5

    6 evaluable cardiac subjects: 1000 mg HCQ 1-2 hours after separation from CPB followed by the highest tolerated dose from the previous 4 phases divided into 2 equal daily doses until the day of MRI imaging on postoperative day 1-5.

    Drug: Hydroxychloroquine

Interventions

06

What researchers measure

Primary outcomes

  1. Ktrans Volume Transfer Constant

    Ktrans represents the "permeability" or "leakage" constant across the blood-brain barrier and is calculated by measuring the amount of gadolinium-based contrast agent in the extravascular-extracellular space. Ktrans is a constant assessed on the postoperative MRI and has no units of measure.

    Time frame: Postoperative day 1-5

07

Results

Posted Jun 12, 2024

Participant flow

Patients undergoing cardiac or noncardiac surgery were recruited at Duke University Medical Center.

Participant flow — Overall Study
MilestonePhase 1Phase 2Phase 3Phase 4Phase 5
Started1212000
Completed66000
Not completed66000
Withdrew: Physician decision33000
Withdrew: Withdrawal by subject11000
Withdrew: Unable to complete mri22000

Outcome measures

PrimaryKtrans Volume Transfer Constant

Ktrans represents the "permeability" or "leakage" constant across the blood-brain barrier and is calculated by measuring the amount of gadolinium-based contrast agent in the extravascular-extracellular space. Ktrans is a constant assessed on the postoperative MRI and has no units of measure.

Time frame:
Postoperative day 1-5
Reported as:
Mean · unitless
Ktrans Volume Transfer Constant
unitlessPhase 1Phase 2
Ktrans Volume Transfer Constant0.225 ± 0.1080.418 ± 0.069

Adverse events

Collected over 6 weeks. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Phase 10/12 (0%)0/12 (0%)3/12 (25%)
Phase 20/12 (0%)1/12 (8.3%)3/12 (25%)
Phase 3———
Phase 4———
Phase 5———
Most frequent serious events
Most frequent serious events
EventPhase 1Phase 2Phase 3Phase 4Phase 5
Respiratory failureRespiratory, thoracic and mediastinal disorders0/121/12———
Most frequent other events
Most frequent other events
EventPhase 1Phase 2Phase 3Phase 4Phase 5
Atrial fibrillationCardiac disorders0/122/12———
NauseaGastrointestinal disorders1/120/12———
VomitingGastrointestinal disorders1/120/12———
ConstipationGastrointestinal disorders1/120/12———
IleusGastrointestinal disorders1/120/12———
HypotensionCardiac disorders1/121/12———

Baseline characteristics

Data not collected on eight participants. There was no enrollment in Phase 3, Phase 4, or Phase 5.

Age, Continuous
Age, Continuous(years)Phase 1Phase 2Phase 3Phase 4Phase 5Total
Mean64.9 ± 4.564.8 ± 5.8———64.9 ± 5.2
Sex: Female, Male
Sex: Female, Male(Participants)Phase 1Phase 2Phase 3Phase 4Phase 5Total
Female24———6
Male64———10
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Phase 1Phase 2Phase 3Phase 4Phase 5Total
Hispanic or Latino00———0
Not Hispanic or Latino88———16
Unknown or Not Reported00———0
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Phase 1Phase 2Phase 3Phase 4Phase 5Total
American Indian or Alaska Native00———0
Asian01———1
Native Hawaiian or Other Pacific Islander00———0
Black or African American00———0
White87———15
More than one race00———0
Unknown or Not Reported00———0
Region of Enrollment
Region of Enrollment(Participants)Phase 1Phase 2Phase 3Phase 4Phase 5Total
United States88———16
08

Study locations

1 site
  • Duke Health
    Durham, North Carolina 27710, United States
09

References and documents

Study documents

  • Protocol and statistical analysis plan · Nov 29, 2020

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 20, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03025087
Lead sponsor
Duke University
Responsible party
Sponsor
First posted
Jan 19, 2017
Start date
Jun 19, 2017
Primary completion
May 22, 2023
Completion
Apr 19, 2024
Results posted
Jun 12, 2024
Last update
Aug 20, 2024

Study contacts

Joseph P Mathew, MD
principal investigator · Duke Health

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drug tested here: Hydroxychloroquine

Start the discussion