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

Primary Purpose

Sleep, Critical Illness

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Dexmedetomidine
Sponsored by
University of Arizona
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sleep focused on measuring Sleep, Critical illness, Cytokine

Eligibility Criteria

21 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Southern Arizona VA Healthcare System

Outcomes

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)

Secondary Outcome Measures

Full Information

First Posted
November 29, 2006
Last Updated
October 26, 2016
Sponsor
University of Arizona
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1. Study Identification

Unique Protocol Identification Number
NCT00405847
Brief Title
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

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
July 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Arizona

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep, Critical Illness
Keywords
Sleep, Critical illness, Cytokine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Randomized
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Primary Outcome Measure Information:
Title
Sleep disruption (Arousals, awakenings and sleep efficiency measured by polysomnography)
Title
Circulating levels of Inflammatory cytokines (TNF-alpha, IL-1, IL-6, IL-10)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sairam Parthasarathy, MD
Organizational Affiliation
SAVAHCS and University of Arizona
Official's Role
Principal Investigator
Facility Information:
Facility Name
Southern Arizona VA Healthcare System
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85723
Country
United States

12. IPD Sharing Statement

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

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