Status:
COMPLETED
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
Lead Sponsor:
Vanderbilt University
Conditions:
Delirium
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 contrib...
Detailed Description
Delirium occurs in 60-80% of ventilated Intensive Care Unit (ICU) patients and is independently associated with prolonged hospital stay, higher cost, a 3-fold increased risk of dying by six months and...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2016
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00095251
Start Date
August 1 2004
End Date
December 1 2016
Last Update
September 11 2018
Active Locations (1)
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1
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232