The Effect of Ramelteon on Delirium and Sleep in Patients Admitted to the ICU

• Status: Unknown status
• Trial end date: 2020-06-01
• Target enrollment: 0
• Participant gender: All

Summary

Delirium is a disturbance in attention and awareness that occurs over a short period of time. Delirium is common in critically ill patients, and poor sleep quality in the intensive care unit (ICU) often worsens delirium. We aim to lower delirium in the intensive care unit (ICU) by using ramelteon, which is a drug used to improve sleep at night.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rhode Island Hospital

Criteria

Inclusion Criteria:

• Adults ≥ 18 years of age newly admitted to ICU and expected to stay in ICU for at least three days as determined by study personnel.

• Able to take medicine via enteral access.

Exclusion Criteria:

• Taking ramelteon or fluvoxamine

• Expected life expectancy of less than 48 hours.

• Pre-existing dementia

• Alcohol withdrawal admission diagnosis

• Acute neurological condition (brain abscess/tumor, head bleed, stroke, seizure)

• Known allergy/intolerance to ramelteon

• Severe liver dysfunction: Hepatic encephalopathy, cirrhosis (Child-Pugh class C or greater)

• Suicide attempt, admission for acute psychiatric illness

• GI bleed or other inability to use enteral nutrition

• Pregnant patient

• Incarcerated

• Prior enrollment into the study

• On paralytics at the time of admission

• Unable to get enteral feeds/meds