Ischemic Stroke, Stroke, Acute
Conditions
Brief summary
This study will measure Interleukin 6 (IL-6), a well-documented inflammatory biomarker that is increased in the acute phase of stroke, and to compare its levels after the administration of melatonin - a well-documented anti-inflammatory and anti-oxidant - that regulates circadian rhythm, which helps promote sleep.
Detailed description
Stroke is a major cause of debilitation in the first world, with few therapeutic options when it comes to improvement in quality of life and morbidity, besides physical and occupational therapy. It affects people of all nationalities, creeds, and socioeconomic classes through a narrow array of mechanisms. With all those mechanisms, a common outcome is shared: derangement of the brain parenchymal architecture. This derangement is non-selective in its destruction with obscuration of the blood brain barrier and the glymphatic system, and with bleeding as a common sequela; the oxidative stress of the hemoglobin-heme-iron compound causing further injury. This study will measure Interleukin 6 (IL-6), a well-documented inflammatory biomarker that is increased in the acute phase of stroke, and to compare its levels after the administration of melatonin - a well-documented anti-inflammatory and anti-oxidant - that regulates circadian rhythm, which helps promote sleep. Any increased time spent in a restful state because of melatonin increases the clearance of waste products after a catastrophic event, like in stroke.
Interventions
DIETARY_SUPPLEMENTMelatonin
Participants in the Melatonin Group will receive 3mg of melatonin each evening for up to seven days for a maximum total of 21mg of melatonin.
Sponsors
University of Florida
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
At discharge, the patient will be assessed via a blinded-physician for NIHSS and this value will be recorded.
Intervention model description
Patients will receive 3mg of melatonin or no melatonin for up to seven days or for the duration of his or hospital stay for a maximum total of 21mg of melatonin.
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Adult patients admitted to the Neuroscience Critical Care Unit with a confirmed ischemic stroke * Patients with a clinical history and examination consistent with an ischemic stroke (stroke must be confirmed by a brain CT and/or MRI scan) * Eligible patients will have been treated with TPA and/or thrombectomy.
Exclusion criteria
* Prisoners * Patients with severe cognitive impairment and/or aphasia (if no family member is available to sign consent) * Recent (\<1 month) infection * Pregnant females
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in serum Interleukin 6 (IL 6) | Baseline, Week 1 | Determine whether Interleukin 6 (IL-6) is lowered after the administration of melatonin. At 6:00 (+/- one hour) each morning for the duration of the hospital stay, patient will have IL-6 biomarker assayed. This testing will continue for the duration of the hospital stay, or for seven days (whichever comes first). |
Countries
United States
Outcome results
None listed