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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2006 by University of Arizona.
Recruitment status was  Recruiting
Information provided by:
University of Arizona
ClinicalTrials.gov Identifier:
First received: November 29, 2006
Last updated: NA
Last verified: November 2006
History: No changes posted
The purpose of this study is to assess the short-term effect of sympatholysis on sleep quality and inflammation in critically ill patients.

Condition Intervention Phase
Critical Illness
Drug: Dexmedetomidine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Pilot Study of Effect of Dexmedetomidine on Sleep and Inflammation in Critically Ill Patients

Resource links provided by NLM:

Further study details as provided by University of Arizona:

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

Estimated Enrollment: 20
Study Start Date: July 2006
Estimated Study Completion Date: May 2007
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.

Ages Eligible for Study:   21 Years to 85 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00405847

Contact: Sairam Parthasarathy, MD 520-971-6808 spartha@arc.arizona.edu

United States, Arizona
Southern Arizona VA Healthcare System Recruiting
Tucson, Arizona, United States, 85723
Principal Investigator: Sairam Parthasarathy, MD         
Sponsors and Collaborators
University of Arizona
Principal Investigator: Sairam Parthasarathy, MD SAVAHCS and University of Arizona
  More Information

ClinicalTrials.gov Identifier: NCT00405847     History of Changes
Other Study ID Numbers: HSC #06-107 
Study First Received: November 29, 2006
Last Updated: November 29, 2006
Health Authority: United States: Institutional Review Board

Keywords provided by University of Arizona:
Critical illness

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

ClinicalTrials.gov processed this record on May 26, 2016