Sleep Intervention During Acute Lung Injury

Completed · Phase 4

Conditions studied: Critical Illness, Sleep, Acute Lung Injury, Acute Respiratory Distress Syndrome

In brief

The central purpose of this proposal is to study the short-term effects of sedation with sympatholysis, using α2 adrenergic agent Dexmedetomidine, on sleep and inflammation in critically ill patients with Acute Lung Injury and Acute Respiratory Disorder Syndrome (ALI/ARDS). An additional objective is to determine the effect of Dexmedetomidine sedation on the in-vitro production of sleep-modulating inflammatory cytokines by peripheral blood mononuclear cells of critically ill patients with ALI/ARDS.

Key facts

Study ID

NCT01050699

Run by

University of Arizona

People needed

90

Starts

2009-08-01

Expected to finish

2019-01-01

Last updated by the study team

2021-08-04

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age range 18-85 (inclusive)
• Potential subjects receiving mechanical ventilation
• Potential subjects must have:
• Acute hypoxemia with a PaO2/FiO2 < 300 mm Hg (for ALI) OR < 200 mm Hg (for ARDS),
• Bilateral infiltrates (including very mild infiltrates)
• No clinical evidence of left atrial hypertension, or a pulmonary artery wedge pressure < 18 mm Hg.
• Potential subjects will be recruited after intubation and following a (systolic BP > 90 mm Hg on 2 or less continuous infusion of pressors) and ventilatory parameters (requiring < 60% fractional inspired O2 concentration [FiO2] and PEEP < 8 cm H2O).

You may not qualify if…

• Acute myocardial infarction or unstable angina or active myocardial ischemia
• Potential subjects who are considered too unstable to undergo this investigation by their primary physician.
• Symptomatic bradycardia (ventricular rate < 50 accompanied by hypotension [Systolic blood pressure < 90 mm Hg] or atrio-ventricular block [second degree type II or greater]).
• Known inability to tolerate beta-blockers or dexmedetomidine.
• Systolic blood pressure < 90 mmHg despite continuous infusions of 2 vasopressors before the start of study drug infusion.
• Potential subjects who are comatose or suffering from severe debilitating neurological disease (Intracerebral hemorrhage).
• History of severe dementia (derived from medical records or family sources).
• Active seizures
• Alcohol abuse by history
• Clinical evidence for decompensated congestive heart failure (elevated jugular venous distension, dependent edema) with echocardiographic evidence for significant systolic heart failure- left ventricular ejection fraction <30%.
• Renal failure (on renal dialysis); Hepatocellular failure (Child-Pugh class C).
• Metastatic or terminal cancer and patients with do-not-resuscitate orders
• Pregnancy
• Potential subjects who are expected to be extubated within 48 hours

Where it is running

• Southern Arizona VA Health Care System — Tucson, Arizona, United States
• University Medical Center — Tucson, Arizona, United States

Full record on ClinicalTrials.gov

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