Effects of Zolpidem CR® in Sleep and Heart Recovery in Cardiac Intensive Care Unit Patients

Acute Coronary Syndrome Clinical Trial

Official title:

Effects of Zolpidem CR in Sleep and Clinical Outcomes of Patients in Cardiac Intensive Care Unit

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01920334
• Other study ID #: 1442/11, Ethics Committee
• Secondary ID: CardioHE, AFIP
• Status: Recruiting
• Phase: Phase 4
• First received: August 7, 2013
• Last updated: August 8, 2013
• Start date: July 2013
• Est. completion date: January 2014

Study information

• Verified date: August 2013
• Source: Associação Fundo de Incentivo à Pesquisa
• Contact: Patrick R Burke, MD
• Phone: 55-11-964288591
• Email: doctorburke[@]hotmail.com
• Is FDA regulated: No
• Health authority: Brazil: Associação Fundo de Incentivo à PesquisaBrazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: January 2014
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Sleep Deprivation

Intervention

Drug:
• Zolpidem CR 12.5mg
Patients will be given zolpidem CR 12.5mg each night for, at least, 3 consecutive nights, including the first night on the Cardiac ICU, when the undergo a full-night polysomnography
• Placebo
Patients will receive placebo pills at night, according to their usual sleep time, from the first night on the Cardiac ICU, until their hospital discharge

Locations

Country	Name	City	State
Brazil	Hospital São Paulo	Sao Paulo	SP

Sponsors (2)

Lead Sponsor	Collaborator
Associação Fundo de Incentivo à Pesquisa	Conselho Nacional de Desenvolvimento Científico e Tecnológico

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Sleep quality analogue visual scale	After receiving the drug or placebo at night, the next morning the patients fill in the sleep quality visual analogue scale	3 consecutive mornings	No
Other	The Pittsburgh Sleep Quality Index	Before the patient receives the drug/placebo, he fills in the Pittsburgh Sleep Quality Index	1 day, before the intervention	No
Other	Epworth Sleepiness Scale	Before receiving the drug or placebo at night, patients fill in the Epworth Sleepiness Scale	1 day, before the intervention	No
Other	Insomnia Severity Index	Before receiving the drug or placebo at night, patients fill in the Insomnia Severity Index	1 day, before the intervention	No
Primary	Sleep efficiency	A full-night polysomnography is conducted in the first night on the ICU	1 day - the first night	No
Secondary	Troponin T	The serum troponin T is measured previously of the intervention and daily for 3 consecutive days	Within the first 3 days after an acute coronary syndrome diagnosis	No
Secondary	Creatine-kinase MB	The serum creatine-kinase MB is measured previously of the intervention and daily for 3 consecutive days	Within the first 3 days after an acute coronary syndrome diagnosis	No