Study to Evaluate Hemodynamic Effect of Different Loading Doses of Precedex in Post-surgical Intensive Care Unit (ICU) Patients
NCT ID: NCT01169571
Last Updated: 2015-07-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
373 participants
OBSERVATIONAL
2010-09-30
2011-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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PROSPECTIVE
Study Groups
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Group I - No loading dose
No loading dose to be administered during the loading-dose paradigms
Dexmedetomidine
Group II - Loading dose over 10 minutes
Loading dose dexmedetomidine 1 mcg/kg administered over 10 minutes during the loading-dose paradigms
Dexmedetomidine
Group III - Loading dose over 20 minutes
Loading dose dexmedetomidine 1 mcg/kg administered over 20 minutes during the loading-dose paradigms
Dexmedetomidine
Interventions
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Dexmedetomidine
Eligibility Criteria
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Inclusion Criteria
2. Initially intubated and mechanically ventilated adult post-operative subjects in an intensive care setting (e.g., post operative care unit, post anesthesia care unit, etc.) that are expected to require sedation for at least 2 hours.
3. Has an American Society of Anesthesiologist (ASA) classification of 1, 2, 3 or 4.
ASA Physical Status Classification System
* P1 A normal healthy subject
* P2 A subject with mild systemic disease
* P3 A subject with severe systemic disease
* P4 A subject with severe systemic disease that is a constant threat to life
* P5 A moribund subject who is not expected to survive without the operation
* P6 A declared brain-dead subject whose organs are being removed for donor purposes.
4. If female, subject must be postmenopausal, surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy), or practicing at least one of the following methods of birth control:
* hormonal contraceptives (oral, parenteral or transdermal) for at least 3 months prior to study drug administration
* intrauterine device (IUD)
* double-barrier method (condoms, contraceptive sponge, diaphragm or vaginal ring with spermicidal jellies or cream).
Exclusion Criteria
2. Subjects with a 2nd degree Mobitz Type II or 3rd degree heart block, unless the subject has a permanent pacemaker or pacing wires are in situ.
3. Subjects with a known allergy to dexmedetomidine.
4. Hypotension based on repeat assessments prior to (within 15 minutes) starting study drug defined as Systolic BP \<90 mmHg or Diastolic BP \<60 mmHg.
5. Pre-existing bradycardia prior (within 15 minutes) to starting study drug defined as HR \<50 bpm.
6. Subjects who, in the opinion of the Investigator, have any other condition where the risks of dexmedetomidine would be expected to outweigh its benefits (e.g., cardiogenic shock on \>2 vasopressors, death anticipated within 48 hours).
18 Years
ALL
No
Sponsors
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Hospira, now a wholly owned subsidiary of Pfizer
INDUSTRY
Responsible Party
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Locations
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Foothills Medical Centre, University of Calgary
Calgary, Alberta, Canada
University of Alberta Hospital, Department of Anesthesiology and Pain Medicine
Edmonton, Alberta, Canada
Red Deer Regional Hospital Centre, Alberta Health Services
Red Deer, Alberta, Canada
Vancouver, British Columbia, Canada
St. Paul's Hospital
Vancouver, British Columbia, Canada
Capital Health-Queen Elizabeth II Health Sciences Center
Halifax, Nova Scotia, Canada
Kingston General Hospital
Kingston, Ontario, Canada
St. Mary's General Hospital
Kitchener, Ontario, Canada
University Hospital
London, Ontario, Canada
Thunder Bay, Ontario, Canada
Department of Anesthesia, St. Michael's Hospital
Toronto, Ontario, Canada
Toronto General Hospital, University Health Network, Department of Anesthesia and Pain Management
Toronto, Ontario, Canada
McGill University Health Centre (MUHC) Royal Victoria Hospital (RVH)
Montreal, Quebec, Canada
McGill University Health Centre, Montreal General Hospital (MGH)
Montreal, Quebec, Canada
Sir Mortimer B. Davis Jewish General Hospital
Montreal, Quebec, Canada
Universite de Sherbrooke
Sherbrooke, Quebec, Canada
Département d'anesthésiologie, Institut universitaire de cardiologie et de pneumologie de Québec
Québec, , Canada
Countries
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Other Identifiers
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DEX-10-03
Identifier Type: -
Identifier Source: org_study_id
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