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
Sponsor:
Information provided by:
University of Arizona
ClinicalTrials.gov Identifier:
NCT00405847
First received: November 29, 2006
Last updated: NA
Last verified: November 2006
History: No changes posted

November 29, 2006
November 29, 2006
July 2006
Not Provided
  • Sleep disruption (Arousals, awakenings and sleep efficiency measured by polysomnography)
  • Circulating levels of Inflammatory cytokines (TNF-alpha, IL-1, IL-6, IL-10)
Same as current
No Changes Posted
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A Pilot Study of Effect of Dexmedetomidine on Sleep and Inflammation in Critically Ill Patients
A Pilot Study of Effect of Dexmedetomidine on Sleep and Inflammation in Critically Ill Patients

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

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
  • Sleep
  • Critical Illness
Drug: Dexmedetomidine
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
20
May 2007
Not Provided

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
Both
21 Years to 85 Years
No
Contact: Sairam Parthasarathy, MD 520-971-6808 spartha@arc.arizona.edu
United States
 
NCT00405847
HSC #06-107
Not Provided
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University of Arizona
Not Provided
Principal Investigator: Sairam Parthasarathy, MD SAVAHCS and University of Arizona
University of Arizona
November 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP