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

Completed · Phase 2

Conditions studied: Delirium

In brief

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).

Key facts

Study ID

NCT00095251

Run by

Vanderbilt University

People needed

100

Starts

2004-08-01

Expected to finish

2016-12-01

Last updated by the study team

2018-09-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Vanderbilt University Medical Center — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.