A Pilot Study of Effect of Dexmedetomidine on Sleep and Inflammation in Critically Ill Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-07-31

Study Completion Date

2007-05-31

Brief Summary

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The purpose of this study is to assess the short-term effect of sympatholysis on sleep quality and inflammation in critically ill patients.

Detailed Description

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Over 1 million patients receive mechanical ventilation every year in the United States. In mechanically ventilated patients, despite sedative infusions, sleep is severely disrupted. Sleep disruption, in turn, can lead to activation of sympathetic nervous system and elevated inflammatory cytokines. Both sympathetic hyperactivity and elevated cytokines have been associated with delirium, which, in turn, is associated with increased mortality and higher healthcare costs. Currently, however, there is very little understanding of the inter-relationship between critical illness, sleep, and neuropsychological well-being. The purpose of this study is to collect preliminary data on the short-term effects of sedation with and without sympatholysis on sleep and inflammation in critically ill patients receiving mechanical ventilation. This pilot study will be accomplished by performing sleep studies and circulating cytokine measurements in critically ill patients randomized to receive two different sedation strategies: Dexmedetomidine versus Midazolam and Fentanyl. The ultimate goal of this program of research is to identify sedation practices that are least associated with adverse short- and long-term consequences, and thereby ultimately help improve sleep quality and quality of life in patients surviving critical illness.

Conditions

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Sleep Critical Illness

Keywords

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Sleep Critical illness Cytokine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Dexmedetomidine

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients requiring mechanical ventilation with a diagnosis of

* Acute Respiratory Distress Syndrome
* Cardiogenic Pulmonary Edema
* Pneumonia
* Chronic obstructive pulmonary disease

Exclusion Criteria

* Patients who are considered too unstable to undergo this investigation by their primary physician
* Comatose patients, or patients with severe debilitating neurological disease
* Renal insufficiency (Sr. Creatinine \> 2 mg/dL)
* Heart block (second or third degree heart block) or sinus bradycardia (heart rate \< 60 beats per minute)
* Pregnancy

Minimum Eligible Age

21 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Sairam Parthasarathy, MD

Role: PRINCIPAL_INVESTIGATOR

SAVAHCS and University of Arizona

Locations

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Southern Arizona VA Healthcare System

Tucson, Arizona, United States

Site Status

Countries

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United States

Other Identifiers

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HSC #06-107

Identifier Type: -

Identifier Source: org_study_id