Status:
COMPLETED
Acute Neurological ICU Sedation Trial (ANIST)
Lead Sponsor:
Johns Hopkins University
Conditions:
Sedation
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
Dexmedetomidine (Precedex, Hospira) is a "super" selective alpha2-agonist - 8-10x more avid binding to alpha2 receptors than clonidine - and may have particularly favorable characteristics as a contin...
Detailed Description
Dexmedetomidine has shown promise in small case series to be an efficacious sedative agent in the intensive care unit (ICU) setting, in both post-surgical and medical patients. A recent publication re...
Eligibility Criteria
Inclusion
- Objective 1:
- Neuroscience patients in the Neuro Critical Care Unit (NCCU) who are:
- 18-80 years of age;
- Mechanically ventilated patients;
- Requiring continuous sedation for a minimum of 9-11 hours (depending on whether or not pt is post-operative), yet frequent neurological examinations or Patients with a Nursing Instrument for Communication of Sedation Score (NICSS) \> 0
- Patient or family able to provide consent.
- Considered to have guarded yet stable neurological state. Not fluctuating intracranial pressure (ICP), cerebral perfusion pressure (CPP), or ongoing known cerebral ischemia if ICP monitoring in place.
- Objective 1:
Exclusion
- Pregnancy.
- ICP\> 30 mm Hg despite therapy if ICP monitored.
- CPP \<70 mm Hg if monitored.
- Occurrence of: new cerebral stroke, hemorrhage, or change in edema by CT, increase in ICP if monitored.
- Neuromuscular paralysis.
- Non-functional cognitive exam - not following commands.
- Renal insufficiency: Serum Creatinine \>2.0 mg/dl or estimated Cr Clearance \<40.0 ml/min.
- Hepatic disease: aspartate aminotransferase (AST), alanine aminotransferase (ALT) \> 300, or international normalized ratio (INR) \> 1.7 not on anticoagulants.
- Severe chronic obstructive pulmonary disease (COPD) with baseline arterial partial pressure of carbon dioxide (pCO2)\>50.
- Suspected alcohol or substance withdrawal.
- Hypotension - requiring pressor therapy to maintain baseline adequate CPP or mean arterial pressure (MAP).
- Cardiac arrhythmia - sinus bradycardia (HR \<60), atrial fibrillation (\>6 PVC's/min)
- Bradycardia- heart rate less than 60 beats per minute.
- Patient does not require mechanical ventilation.
- Objective 2: Inclusion Criteria:
- Critically ill neuroscience patients who are:
- 18-80 years of age;
- Mechanically ventilated;
- Require Intracranial Pressure (ICP) monitoring by either subarachnoid bolt (SA bolt), or by an Intra-Ventricular Catheter (IVC).
- Amenable for placement of intra-cerebral oxygen sensor or jugular bulb catheter.
- Have glaucoma coma score (GCS) score \> 5 that requires sedation.
- Requiring continuous sedation for minimum of 9-11 hours (depending on whether or not pt is post-operative) , yet frequent neurological examinations every 1-2 hours or Patients with a NICSS score \> 0
- Patient or family able to provide consent.
- Objective 2:
Key Trial Info
Start Date :
May 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2007
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT00390871
Start Date
May 1 2005
End Date
December 1 2007
Last Update
May 16 2019
Active Locations (1)
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1
Johns Hopkins University
Baltimore, Maryland, United States, 21287