MENDS Study: Trial in Ventilated ICU Patients Comparing an Alpha2 Agonist Versus a Gamma Aminobutyric Acid (GABA)-Agonist to Determine Delirium Rates, Efficacy of Sedation, Analgesia and Discharge Cognitive Status

• Status: Completed
• Trial end date: 2016-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Delirium has recently been shown as a predictor of death, increased cost, and longer length of stay in ventilated patients. Sedative and analgesic medications relieve anxiety and pain, but may contribute to patients' transitioning into delirium. It is possible that modifying the paradigm for sedation using novel therapies targeted at different receptors, such as dexmedetomidine targeting alpha2 receptors and sparing the GABA receptors, could provide efficacious sedation yet reduce the development, duration, and severity of acute brain dysfunction (delirium).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vanderbilt University; Vanderbilt University Medical Center
• Treatments: Dexmedetomidine; gamma-Aminobutyric Acid; Lorazepam

Criteria

Inclusion Criteria:

• Male or female adult patients admitted to the medical and surgical ICU for critical illnesses requiring mechanical ventilation with expectation of being mechanically ventilated for greater than 24 hours

Exclusion Criteria:

• Subjects who are less than 18 years of age

• Subjects who are pregnant (a pregnancy test will be performed on all women of child bearing age)

• Inability to obtain informed consent from the patient or his/her surrogate

• Subjects in the ICU due to a lack of beds elsewhere in the hospital, triage issues, or withdrawal of care decisions rather than severity of illness

• Subjects admitted with alcohol or drug overdoses, suicide attempts, or alcohol/delirium tremens

• Subjects who are physiologically benzodiazepine dependent, and at risk for withdrawal syndromes

• Subjects with chronic pain syndromes on maintenance narcotics

• Subjects treated within the last 30 days with a drug or device that has not received regulatory approval as of study entry

• Subjects with a psychiatric history for which they are on neuroleptic treatment

• Subjects with documented moderate to severe dementia

• Subjects with anoxic brain injuries, strokes, neurotrauma, or neuromuscular disorders such as myasthenia gravis or Guillain Barre syndrome

• Medical team following patient unwilling to use the sedation regimens

• Subjects whose family and/or physician have not committed to aggressive support for 72 hours or who are likely to withdraw within 72 hours

• Subjects who are moribund and not expected to survive 24 hours

• Subjects not expected to survive hospital discharge due to preexisting uncorrectable medical condition

• Documented allergy to study medications

• Subjects who have either Child-Pugh Class B or C cirrhosis

• Subjects with active coronary artery disease at time of screening as defined by any recent evidence of ischemia, documented myocardial infarction, or coronary intervention within the past 6 months.

• Subjects with advanced heart block at time of screening