Sleep Intervention During Acute Lung Injury

• Status: Completed
• Trial end date: 2019-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Arizona
• Collaborator: National Heart, Lung, and Blood Institute (NHLBI)
• Treatments: Dexmedetomidine; Fentanyl; Midazolam

Criteria

Inclusion Criteria:

• Age range 18-85 (inclusive)

• Potential subjects receiving mechanical ventilation

• Potential subjects must have:

1. Acute hypoxemia with a PaO2/FiO2 < 300 mm Hg (for ALI) OR < 200 mm Hg (for ARDS),

2. Bilateral infiltrates (including very mild infiltrates)

3. 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).

Exclusion Criteria:

• 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.

1. Symptomatic bradycardia (ventricular rate < 50 accompanied by hypotension [Systolic blood pressure < 90 mm Hg] or atrio-ventricular block [second degree type II or greater]).

2. Known inability to tolerate beta-blockers or dexmedetomidine.

3. 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