Clinical trial NCT01169571: Study to Evaluate Hemodynamic Effect of Different Loading Doses of Precedex in Post-surgical Intensive Care Unit (ICU) Patients
Official title: Phase 4, Open-Label Study Evaluating the Hemodynamic Effect of Differing Loading Regimens of Precedex in a Post-Surgical Intensive Care Patient Population
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intensive Care Unit
Keywords: Initially intubated
Mechanically ventilated
Post-surgical
Lead sponsor: Hospira, now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2010-07-26
Enrollment: 373
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Initially intubated and mechanically ventilated post-surgical adult male and female subjects in an intensive care setting.

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 intensive care setting.


Eligibility criteria: Inclusion Criteria:

1. Subject or the subject's legally authorized representative has voluntarily signed and dated the informed consent document approved by the Research Ethics Board (REB).
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:

1. Subjects \<18 years of age.
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).

Primary outcomes:
measure: Incidence of clinically meaningful hemodynamic abnormality (CMHA)
timeFrame: During the first 2 hours of study drug administration
Secondary outcomes:
measure: Incidence of clinically meaningful hemodynamic abnormality (CMHA) during the maintenance infusion period.
timeFrame: Maintenance infusion period (2 to 24 hours)
measure: Incidence of adverse events (AEs) between the 3 loading-dose paradigms
timeFrame: Post-dexmedetomidine 24-hour observation period
measure: Incidence of paradoxical hypertension
timeFrame: During the first 2 hours of the post-dexmedetomidine observation period
measure: Incidence of paradoxical hypertension
timeFrame: Post-dexmedetomidine 24-hour observation period
measure: Amount of analgesics administered
timeFrame: 2 hours prior, and for the first 2 hours during, study drug administration
measure: Amount of sedatives administered
timeFrame: 2 hours prior, and for the first 2 hours during, study drug administration
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Foothills Medical Centre, University of Calgary
state: Alberta
city: Edmonton
country: Canada
facility: University of Alberta Hospital, Department of Anesthesiology and Pain Medicine
state: Alberta
city: Red Deer
country: Canada
facility: Red Deer Regional Hospital Centre, Alberta Health Services
state: Alberta
city: Vancouver
country: Canada
state: British Columbia
city: Vancouver
country: Canada
facility: St. Paul's Hospital
state: British Columbia
city: Halifax
country: Canada
facility: Capital Health-Queen Elizabeth II Health Sciences Center
state: Nova Scotia
city: Kingston
country: Canada
facility: Kingston General Hospital
state: Ontario
city: Kitchener
country: Canada
facility: St. Mary's General Hospital
state: Ontario
city: London
country: Canada
facility: University Hospital
state: Ontario
city: Thunder Bay
country: Canada
state: Ontario
city: Toronto
country: Canada
facility: Department of Anesthesia, St. Michael's Hospital
state: Ontario
city: Toronto
country: Canada
facility: Toronto General Hospital, University Health Network, Department of Anesthesia and Pain Management
state: Ontario
city: Montreal
country: Canada
facility: McGill University Health Centre (MUHC) Royal Victoria Hospital (RVH)
state: Quebec
city: Montreal
country: Canada
facility: McGill University Health Centre, Montreal General Hospital (MGH)
state: Quebec
city: Montreal
country: Canada
facility: Sir Mortimer B. Davis Jewish General Hospital
state: Quebec
city: Sherbrooke
country: Canada
facility: Universite de Sherbrooke
state: Quebec
city: Quebec
country: Canada
facility: Département d'anesthésiologie, Institut universitaire de cardiologie et de pneumologie de Québec
Study officials:
References: