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Completed

NCT Number: NCT00405847

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.

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Key information

Age range

21 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Southern Arizona VA Healthcare System

Tucson, Arizona, 85723, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexmedetomidine

Drug

Primary outcomes

  1. Sleep disruption (Arousals, awakenings and sleep efficiency measured by polysomnography)

  2. Circulating levels of Inflammatory cytokines (TNF-alpha, IL-1, IL-6, IL-10)

Sponsors and collaborators

Lead sponsor

University of Arizona

Other

Registry information

Important dates

Study start
2006
Study completion
2007
First posted
Nov 30, 2006
Registry last updated
Oct 27, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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