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

University of Arizona

Status and phase

Completed

Phase 4

Conditions

Critical Illness

Sleep

Treatments

Drug: Dexmedetomidine

Study type

Interventional

Funder types

Other

Identifiers

NCT00405847

HSC #06-107

Details and patient eligibility

About

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

Full 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.

Enrollment

17 patients

Sex

All

Ages

21 to 85 years old

Volunteers

No 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