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
The purpose of this study is to determine whether hydroxychloroquine decreases the relative leakage of the brain barrier after surgery.
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.
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.
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Exclusion Criteria:
6 evaluable subjects (3 cardiac, 3 noncardiac patients): 1000 mg HCQ on the day prior to surgery.
Drug: Hydroxychloroquine
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
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
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
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
Participants will be getting hydroxychloroquine
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
Patients undergoing cardiac or noncardiac surgery were recruited at Duke University Medical Center.
| Milestone | Phase 1 | Phase 2 | Phase 3 | Phase 4 | Phase 5 |
|---|---|---|---|---|---|
| Started | 12 | 12 | 0 | 0 | 0 |
| Completed | 6 | 6 | 0 | 0 | 0 |
| Not completed | 6 | 6 | 0 | 0 | 0 |
| Withdrew: Physician decision | 3 | 3 | 0 | 0 | 0 |
| Withdrew: Withdrawal by subject | 1 | 1 | 0 | 0 | 0 |
| Withdrew: Unable to complete mri | 2 | 2 | 0 | 0 | 0 |
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.
| unitless | Phase 1 | Phase 2 |
|---|---|---|
| Ktrans Volume Transfer Constant | 0.225 ± 0.108 | 0.418 ± 0.069 |
Collected over 6 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Phase 1 | 0/12 (0%) | 0/12 (0%) | 3/12 (25%) |
| Phase 2 | 0/12 (0%) | 1/12 (8.3%) | 3/12 (25%) |
| Phase 3 | — | — | — |
| Phase 4 | — | — | — |
| Phase 5 | — | — | — |
| Event | Phase 1 | Phase 2 | Phase 3 | Phase 4 | Phase 5 |
|---|---|---|---|---|---|
| Respiratory failureRespiratory, thoracic and mediastinal disorders | 0/12 | 1/12 | — | — | — |
| Event | Phase 1 | Phase 2 | Phase 3 | Phase 4 | Phase 5 |
|---|---|---|---|---|---|
| Atrial fibrillationCardiac disorders | 0/12 | 2/12 | — | — | — |
| NauseaGastrointestinal disorders | 1/12 | 0/12 | — | — | — |
| VomitingGastrointestinal disorders | 1/12 | 0/12 | — | — | — |
| ConstipationGastrointestinal disorders | 1/12 | 0/12 | — | — | — |
| IleusGastrointestinal disorders | 1/12 | 0/12 | — | — | — |
| HypotensionCardiac disorders | 1/12 | 1/12 | — | — | — |
Data not collected on eight participants. There was no enrollment in Phase 3, Phase 4, or Phase 5.
| Age, Continuous(years) | Phase 1 | Phase 2 | Phase 3 | Phase 4 | Phase 5 | Total |
|---|---|---|---|---|---|---|
| Mean | 64.9 ± 4.5 | 64.8 ± 5.8 | — | — | — | 64.9 ± 5.2 |
| Sex: Female, Male(Participants) | Phase 1 | Phase 2 | Phase 3 | Phase 4 | Phase 5 | Total |
|---|---|---|---|---|---|---|
| Female | 2 | 4 | — | — | — | 6 |
| Male | 6 | 4 | — | — | — | 10 |
| Ethnicity (NIH/OMB)(Participants) | Phase 1 | Phase 2 | Phase 3 | Phase 4 | Phase 5 | Total |
|---|---|---|---|---|---|---|
| Hispanic or Latino | 0 | 0 | — | — | — | 0 |
| Not Hispanic or Latino | 8 | 8 | — | — | — | 16 |
| Unknown or Not Reported | 0 | 0 | — | — | — | 0 |
| Race (NIH/OMB)(Participants) | Phase 1 | Phase 2 | Phase 3 | Phase 4 | Phase 5 | Total |
|---|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | — | — | — | 0 |
| Asian | 0 | 1 | — | — | — | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | — | — | — | 0 |
| Black or African American | 0 | 0 | — | — | — | 0 |
| White | 8 | 7 | — | — | — | 15 |
| More than one race | 0 | 0 | — | — | — | 0 |
| Unknown or Not Reported | 0 | 0 | — | — | — | 0 |
| Region of Enrollment(Participants) | Phase 1 | Phase 2 | Phase 3 | Phase 4 | Phase 5 | Total |
|---|---|---|---|---|---|---|
| United States | 8 | 8 | — | — | — | 16 |
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Studies of the drug tested here: Hydroxychloroquine