Clinical trial NCT00405847: A Pilot Study of Effect of Dexmedetomidine on Sleep and Inflammation in Critically Ill Patients
Official title: A Pilot Study of Effect of Dexmedetomidine on Sleep and Inflammation in Critically Ill Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Sleep
Critical Illness
Keywords: Sleep
Critical illness
Cytokine
Lead sponsor: University of Arizona
Sponsor class: OTHER
First posted: 2006-11-30
Enrollment: 17
Sex: ALL
Minimum age (years): 21
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: Sleep disruption (Arousals, awakenings and sleep efficiency measured by polysomnography)
measure: Circulating levels of Inflammatory cytokines (TNF-alpha, IL-1, IL-6, IL-10)
Secondary outcomes:
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Southern Arizona VA Healthcare System
state: Arizona
Study officials:
affiliation: SAVAHCS and University of Arizona
name: Sairam Parthasarathy, MD
role: PRINCIPAL_INVESTIGATOR
References: