Clinical trial NCT01920334: Effects of Zolpidem CR® in Sleep and Heart Recovery in Cardiac Intensive Care Unit Patients
Official title: Effects of Zolpidem CR in Sleep and Clinical Outcomes of Patients in Cardiac Intensive Care Unit
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Acute Coronary Syndrome
Sleep Deprivation
Keywords: coronary disease
heart diseases
enzymes
sleep
troponin
zolpidem
Lead sponsor: Associação Fundo de Incentivo à Pesquisa
Sponsor class: OTHER
Collaborators: name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
First posted: 2013-08-12
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 release).

The study hypothesis is that sleeping better can improve the heart recovery in patients with a diagnosis of acute coronary syndrome.

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, may be related to echo and electrocardiographic changes that may potentially be predictors of cardiac arrhythmias.

The objective is to evaluate the effects of early treatment with zolpidem controlled release (CR®) compared to a placebo on clinical and polysomnographic parameters for patients in a cardiac ICU who had recently been diagnosed with acute coronary syndrome.

A double blind, randomized, placebo-controlled study will be conducted in cardiac ICU patients who had been diagnosed with acute coronary syndrome. The patients in group A will receive placebo and patients in group B will receive zolpidem CR® 12.5 mg from the first night of hospitalization until their discharge. Patients will undergo overnight full polysomnography on the first night in the ICU and will complete a sleep diary with a visual analogue scale to evaluate sleep quality in the morning after the first 3 nights of hospitalization. The results of the routine ICU laboratory tests including the serum levels of cardiac enzymes \[troponin T and creatine kinase MB (CK-MB)\] will be collected preceding the first dose of the drug/placebo, and then daily thereafter.

Eligibility criteria: Inclusion Criteria:

* Patients from 18 to 75 years of age
* Diagnosis of acute coronary syndrome
* Capable of swallowing pills
* Capable of filling in the questionaires

Exclusion Criteria:

* 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

Primary outcomes:
measure: Sleep efficiency
timeFrame: 1 day - the first night
Secondary outcomes:
measure: Troponin T
timeFrame: Within the first 3 days after an acute coronary syndrome diagnosis
measure: Creatine-kinase MB
timeFrame: Within the first 3 days after an acute coronary syndrome diagnosis
Other outcomes:
measure: Sleep quality analogue visual scale
timeFrame: 3 consecutive mornings
measure: The Pittsburgh Sleep Quality Index
timeFrame: 1 day, before the intervention
measure: Epworth Sleepiness Scale
timeFrame: 1 day, before the intervention
measure: Insomnia Severity Index
timeFrame: 1 day, before the intervention
Locations:
city: Sao Paulo
country: Brazil
facility: Hospital São Paulo
state: SP
Study officials:
affiliation: Associação Fundo de Incentivo à Pesquisa
name: Patrick R Burke, MD
role: PRINCIPAL_INVESTIGATOR
References: