Individuals Undergoing Cardiac and General SurgeryPhase 4NCT03025087
Hydroxychloroquine and Cognitive Function After Surgery
A Phase 4 study testing Hydroxychloroquine in people with Individuals Undergoing Cardiac and General Surgery, run by Duke University at 1 site in United States.
Trial summary
The purpose of this study is to determine whether hydroxychloroquine decreases the relative leakage of the brain barrier after surgery. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Individuals Undergoing Cardiac and General Surgery
- What is being tested?
- Hydroxychloroquine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jun 2017to 19 Apr 2024
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, age ≥ 50 years old.
- Patients scheduled to undergo cardiac surgery (CABG, CABG + Valve, Valve) with CPB.
- Patient has voluntarily signed and dated the study-specific informed consent form approved by Duke University Health System Institutional Review Board (DUHS IRB)
Who cannot join
- 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
Show all 22Show fewer
- Patients with a history of alcohol abuse within 2 years of screening
- Patients with a 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 < 30ml/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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- Hydroxychloroquine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Participants will be getting hydroxychloroquine
| Study group | Role | What they receive |
|---|---|---|
| Phase 1 | Experimental | 6 evaluable subjects (3 cardiac, 3 noncardiac patients): 1000 mg HCQ on the day prior to surgery. Receives: Drug: Hydroxychloroquine |
| Phase 2 | Experimental | 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 Receives: Drug: Hydroxychloroquine |
| Phase 3 | Experimental | 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. Receives: Drug: Hydroxychloroquine |
| Phase 4 | Experimental | 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. Receives: Drug: Hydroxychloroquine |
| Phase 5 | Experimental | 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. Receives: Drug: Hydroxychloroquine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Postoperative day 1-5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2017 (estimated)
- Study start19 Jun 2017
- Primary completion22 May 2023
- Study completion19 Apr 2024
Why it stopped: Showed no benefit
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Individuals Undergoing Cardiac and General SurgeryStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joseph P Mathew, MD, Principal investigator, Duke Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03025087
- Sponsor's protocol ID
- Pro00046611
- Status last verified
- Jul 2024
- First submitted
- 17 Jan 2017
- Last updated
- 20 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hydroxychloroquine and Cognitive Function After Surgery
- ClinicalTrials.gov ID
- NCT03025087
- Acronym / sponsor ID
- Pro00046611
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Showed no benefit
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 19 Jun 2017 (actual)
- Primary completion
- 22 May 2023 (actual)
- Study completion
- 19 Apr 2024 (actual)
- First posted
- 19 Jan 2017 (estimated)
- Results
- Posted 12 Jun 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether hydroxychloroquine decreases the relative leakage of the brain barrier after surgery.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Phase 1 | Experimental | Drug: Hydroxychloroquine6 evaluable subjects (3 cardiac, 3 noncardiac patients): 1000 mg HCQ on the day prior to surgery. |
| Phase 2 | Experimental | Drug: Hydroxychloroquine6 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 |
| Phase 3 | Experimental | Drug: Hydroxychloroquine6 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. |
| Phase 4 | Experimental | Drug: Hydroxychloroquine6 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. |
| Phase 5 | Experimental | Drug: Hydroxychloroquine6 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. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female, age ≥ 50 years old.
- Patients scheduled to undergo cardiac surgery (CABG, CABG + Valve, Valve) with CPB.
- Patient has voluntarily signed and dated the study-specific informed consent form approved by Duke University Health System Institutional Review Board (DUHS IRB)
Key exclusion criteria (22 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HydroxychloroquineParticipants will be getting hydroxychloroquine | Drug | Phase 1, Phase 2, Phase 3, Phase 4, Phase 5 |
Primary outcome
Ktrans Volume Transfer Constant
Time frame: Postoperative day 1-5
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Individuals Undergoing Cardiac and General Surgery
Active, not recruitingObservational study
Pulmonary Function, Muscle Strength, and Functional Capacity in Minimally Invasive Cardiac Surgery
Cardiac Surgery, Muscle Weakness | Patient
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joseph P Mathew, MD principal investigator
Duke Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Hydroxychloroquine in people with Individuals Undergoing Cardiac and General Surgery, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Jun 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ktrans Volume Transfer Constant (time frame: Postoperative day 1-5). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2024.