Melatonin in Acute Stroke

University of Florida

Status: Withdrawn

Conditions: Ischemic Stroke; Stroke, Acute

Treatments: Dietary Supplement: Melatonin

Study type: Interventional

Funder types: Other

Identifiers

NCT03843008

IRB201801934

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

0 participants in 2 patient groups

Melatonin Group

Experimental group

Description:

Participants will receive 3mg of melatonin at 18:00 (+/- one hour) each evening up to seven days or for the duration of his or her hospital stay.

Treatment:

Dietary Supplement: Melatonin

No Melatonin Group

No Intervention group

Description:

Participants will receive no melatonin for the length of their hospital stay.