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
  Purpose

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
Sleep
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.

  Eligibility

Ages Eligible for Study:   21 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00405847

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

Locations
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
Investigators
Principal Investigator: Sairam Parthasarathy, MD SAVAHCS and University of Arizona
  More Information

No publications provided

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:
Sleep
Critical illness
Cytokine

Additional relevant MeSH terms:
Critical Illness
Inflammation
Disease Attributes
Pathologic Processes
Dexmedetomidine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Analgesics, Non-Narcotic
Analgesics
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

ClinicalTrials.gov processed this record on July 23, 2014