Status:
COMPLETED
Study to Evaluate Hemodynamic Effect of Different Loading Doses of Precedex in Post-surgical Intensive Care Unit (ICU) Patients
Lead Sponsor:
Hospira, now a wholly owned subsidiary of Pfizer
Conditions:
Intensive Care Unit
Eligibility:
All Genders
18+ years
Brief Summary
The objective of this study is to characterize the hemodynamic effects of Precedex (dexmedetomidine (DEX)) during 3 loading-dose paradigms in mechanically ventilated post-surgical subjects in an inten...
Eligibility Criteria
Inclusion
- Subject or the subject's legally authorized representative has voluntarily signed and dated the informed consent document approved by the Research Ethics Board (REB).
- 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.
- 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.
- 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
- Subjects \<18 years of age.
- 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.
- Subjects with a known allergy to dexmedetomidine.
- Hypotension based on repeat assessments prior to (within 15 minutes) starting study drug defined as Systolic BP \<90 mmHg or Diastolic BP \<60 mmHg.
- Pre-existing bradycardia prior (within 15 minutes) to starting study drug defined as HR \<50 bpm.
- 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).
Key Trial Info
Start Date :
September 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 1 2011
Estimated Enrollment :
373 Patients enrolled
Trial Details
Trial ID
NCT01169571
Start Date
September 1 2010
End Date
June 1 2011
Last Update
July 24 2015
Active Locations (17)
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1
Foothills Medical Centre, University of Calgary
Calgary, Alberta, Canada, T2N 2T9
2
University of Alberta Hospital, Department of Anesthesiology and Pain Medicine
Edmonton, Alberta, Canada, T6G 2G3
3
Red Deer Regional Hospital Centre, Alberta Health Services
Red Deer, Alberta, Canada, T4N 4E7
4
Vancouver, British Columbia, Canada, V5Z 1M9