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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00405847
Recruitment Status : Completed
First Posted : November 30, 2006
Last Update Posted : October 27, 2016
Information provided by:
University of Arizona

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

Condition or disease Intervention/treatment Phase
Sleep Critical Illness Drug: Dexmedetomidine Phase 4

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Pilot Study of Effect of Dexmedetomidine on Sleep and Inflammation in Critically Ill Patients
Study Start Date : July 2006
Actual Study Completion Date : May 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Sleep disruption (Arousals, awakenings and sleep efficiency measured by polysomnography)
  2. Circulating levels of Inflammatory cytokines (TNF-alpha, IL-1, IL-6, IL-10)

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00405847

United States, Arizona
Southern Arizona VA Healthcare System
Tucson, Arizona, United States, 85723
Sponsors and Collaborators
University of Arizona
Principal Investigator: Sairam Parthasarathy, MD SAVAHCS and University of Arizona Identifier: NCT00405847     History of Changes
Other Study ID Numbers: HSC #06-107
First Posted: November 30, 2006    Key Record Dates
Last Update Posted: October 27, 2016
Last Verified: October 2016

Keywords provided by University of Arizona:
Critical illness

Additional relevant MeSH terms:
Critical Illness
Pathologic Processes
Disease Attributes
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action