Status:
UNKNOWN
Effects of Zolpidem CR® in Sleep and Heart Recovery in Cardiac Intensive Care Unit Patients
Lead Sponsor:
Associação Fundo de Incentivo à Pesquisa
Collaborating Sponsors:
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Conditions:
Acute Coronary Syndrome
Sleep Deprivation
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief Summary
A double blind, randomized, placebo-controlled study will be conducted in cardiac ICU patients who had been diagnosed with acute coronary syndrome, using a sleep promoting drug (zolpidem controlled re...
Detailed Description
The environment of an Intensive Care Unit (ICU) is notoriously inhospitable to patients who experience a period of sleep deprivation (SD). Recent research has shown that SD, even in the short-term, ma...
Eligibility Criteria
Inclusion
- Patients from 18 to 75 years of age
- Diagnosis of acute coronary syndrome
- Capable of swallowing pills
- Capable of filling in the questionaires
Exclusion
- Class IV heart failure according to the New York heart association functional class,
- Patients in a coma
- Patients receiving mechanical ventilation
- Patients who regularly use benzodiazepines or other medications for inducing sleep
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2014
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT01920334
Start Date
July 1 2013
End Date
January 1 2014
Last Update
August 12 2013
Active Locations (1)
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1
Hospital São Paulo
São Paulo, São Paulo, Brazil, 04023062