Sleep Intervention During Acute Lung Injury
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|ClinicalTrials.gov Identifier: NCT01050699|
Recruitment Status : Completed
First Posted : January 15, 2010
Last Update Posted : August 4, 2021
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|Condition or disease||Intervention/treatment||Phase|
|Critical Illness Sleep Acute Lung Injury Acute Respiratory Distress Syndrome||Drug: Dexmedetomidine Drug: Midazolam and Fentanyl||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||90 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Sleep Intervention During Acute Lung Injury|
|Study Start Date :||August 2009|
|Actual Primary Completion Date :||January 2019|
|Actual Study Completion Date :||January 2019|
Dexmedetomidine plus saline
Intravenous continuous infusion will be initiated with a (optional) loading dose of 1 mcg/Kg over 10 minutes followed by a maintenance infusion of 0.5 mcg/kg/hour for 24 hours.
Other Name: Precedex
Active Comparator: Usual Care
Midazolam and Fentanyl
Drug: Midazolam and Fentanyl
Midazolam (Versed): Loading dose 2-4 mg IV bolus followed by continuous infusion at 1-7 mg/hour.
Open label aliquots for pain (Midazolam 1- 4 mg IV bolus.)
Fentanyl: Loading dose 50-200 mcg IV bolus; Continuous infusion rate 50-300 mcg/hour. Open label aliquots for pain (Fentanyl 50 - 200 mcg IV bolus.)
- Specific Aim 1: To assess the short-term effect of an α2 adrenergic agent on sleep quality in critically ill patients with ALI/ARDS. [ Time Frame: 72 hours ]
- Specific Aim 2: To assess the short-term effect of an α2 adrenergic agent on sleep-modulating inflammatory cytokines in critically ill patients with ALI/ARDS. [ Time Frame: 72 hours ]
- Specific aim 3: To determine the effect of α2 adrenergic agent on the in-vitro production of sleep-modulating inflammatory cytokines by peripheral blood mononuclear cells of patients with ALI/ARDS. [ Time Frame: 48 hours ]
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|Ages Eligible for Study:||18 Years to 85 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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).
- 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
- Potential subjects who are expected to be extubated within 48 hours
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01050699
|United States, Arizona|
|Southern Arizona VA Health Care System|
|Tucson, Arizona, United States, 85723|
|University Medical Center|
|Tucson, Arizona, United States, 85724|
|Principal Investigator:||Sairam Parthasarathy, MD||University of Arizona|
|Responsible Party:||Sairam Parthasarathy, Associate Professor of Medicine, University of Arizona|
|Other Study ID Numbers:||
1R01HL095748-01A1 ( U.S. NIH Grant/Contract )
|First Posted:||January 15, 2010 Key Record Dates|
|Last Update Posted:||August 4, 2021|
|Last Verified:||August 2021|
acute lung injury
acute respiratory distress syndrome
Respiratory Distress Syndrome
Respiratory Distress Syndrome, Newborn
Acute Lung Injury
Wounds and Injuries
Respiratory Tract Diseases
Infant, Premature, Diseases
Infant, Newborn, Diseases
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Molecular Mechanisms of Pharmacological Action