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

Critical Illness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00405847
• Other study ID #: HSC #06-107
• Status: Completed
• Phase: Phase 4
• First received: November 29, 2006
• Last updated: October 26, 2016
• Start date: July 2006
• Est. completion date: May 2007

Study information

• Verified date: October 2016
• Source: University of Arizona
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: May 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 85 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Critical Illness
• Inflammation
• Sleep

Intervention

Drug:
• Dexmedetomidine

Locations

Country	Name	City	State
United States	Southern Arizona VA Healthcare System	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
University of Arizona

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sleep disruption (Arousals, awakenings and sleep efficiency measured by polysomnography)
Primary	Circulating levels of Inflammatory cytokines (TNF-alpha, IL-1, IL-6, IL-10)